Trial Outcomes & Findings for Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty (NCT NCT01410240)
NCT ID: NCT01410240
Last Updated: 2014-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
137 participants
Primary outcome timeframe
Pre-operative and 2 days post-operatively
Results posted on
2014-06-06
Participant Flow
Patients were enrolled at 12 clinical sites in the United States, beginning October 2011
137 participants were enrolled and screened. 5 were screen failures. 14 withdrew prior to surgery (1 physician decision, 4 study terminated, 8 withdrawn by participant, 1 sponsor educator not available). 12 were run-in participants. Therefore, 106 of the 137 enrolled were randomized.
Participant milestones
| Measure |
Standard of Care (SoC)
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
FLOSEAL + Standard of Care (SoC) Run-In Participants
This arm/group only includes the 12 initial "run-in" participants (one for each site permitted to familiarize the investigators with the study procedures and the use of FLOSEAL)
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
12
|
|
Overall Study
COMPLETED
|
52
|
52
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Standard of Care (SoC)
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
FLOSEAL + Standard of Care (SoC) Run-In Participants
This arm/group only includes the 12 initial "run-in" participants (one for each site permitted to familiarize the investigators with the study procedures and the use of FLOSEAL)
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Missed week 6 assessments
|
1
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Standard of Care (SoC)
n=53 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC) - Non-Run-In
n=53 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC) - Run-In
n=12 Participants
Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 8.09 • n=99 Participants
|
64.8 years
STANDARD_DEVIATION 7.73 • n=107 Participants
|
59.4 years
STANDARD_DEVIATION 8.49 • n=206 Participants
|
64.8 years
STANDARD_DEVIATION 8.14 • n=7 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
53 participants
n=107 Participants
|
12 participants
n=206 Participants
|
118 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Pre-operative and 2 days post-operativelyPopulation: Full Analysis Set Participants who required a transfusion prior to the primary outcome assessment of Hgb level at postoperative Day 2 were excluded from the primary outcome analysis.
Outcome measures
| Measure |
Standard of Care (SoC)
n=46 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=41 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
|
-3.73 g/dL
Standard Deviation 1.497
|
-3.70 g/dL
Standard Deviation 1.205
|
PRIMARY outcome
Timeframe: Throughout the study period, 1 year and 4 monthsPopulation: Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
* Proportion of Participants who have serious injuries (SIs) related to IP * Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP
Outcome measures
| Measure |
Standard of Care (SoC)
n=65 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=53 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
Participants who have SIs related to IP
|
0.00 Proportion of participants
Interval 0.0 to 0.055
|
0.00 Proportion of participants
Interval 0.0 to 0.067
|
|
Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
Participants who have non-SAEs related to IP
|
0.02 Proportion of participants
Interval 0.0 to 0.083
|
0.00 Proportion of participants
Interval 0.0 to 0.067
|
SECONDARY outcome
Timeframe: Pre-operative and day 1 post-operativelyPopulation: Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
Outcome measures
| Measure |
Standard of Care (SoC)
n=48 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=45 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively
|
-3.02 g/dL
Standard Deviation 1.069
|
-3.15 g/dL
Standard Deviation 1.217
|
SECONDARY outcome
Timeframe: Pre-operative and day 3 post-operativelyPopulation: Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
Outcome measures
| Measure |
Standard of Care (SoC)
n=39 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=31 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively
|
-3.81 g/dL
Standard Deviation 1.427
|
-3.84 g/dL
Standard Deviation 1.324
|
SECONDARY outcome
Timeframe: Pre-operative and day 1 post-operativelyPopulation: Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
Outcome measures
| Measure |
Standard of Care (SoC)
n=48 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=45 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in Hematocrit (Hct) at Postoperative Day 1
|
-9.0 percent
Standard Deviation 3.85
|
-8.8 percent
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: Pre-operative and day 2 post-operativelyPopulation: Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
Outcome measures
| Measure |
Standard of Care (SoC)
n=44 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=40 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in Hematocrit (Hct) at Postoperative Day 2
|
-11.2 percent
Standard Deviation 4.67
|
-10.6 percent
Standard Deviation 4.21
|
SECONDARY outcome
Timeframe: Pre-operative and day 3 post-operativelyPopulation: Full Analysis Set Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
Outcome measures
| Measure |
Standard of Care (SoC)
n=39 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=31 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in Hematocrit (Hct) at Postoperative Day 3
|
-11.1 percent
Standard Deviation 4.46
|
-11.0 percent
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: Intra-operatively (on day of surgery = Day 0)Population: Full Analysis Set
Measured from the time point of the tourniquet inflation to deflation using the same watch/clock
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Total Tourniquet Time
|
49.2 minutes
Standard Deviation 19.76
|
47.3 minutes
Standard Deviation 17.45
|
SECONDARY outcome
Timeframe: Intra-operatively (Day 0)Population: Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 15 Run-In participants
Outcome measures
| Measure |
Standard of Care (SoC)
n=65 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Amount of FLOSEAL Applied
|
18.1 mL
Standard Deviation 5.52
|
—
|
SECONDARY outcome
Timeframe: Time from first incision to complete wound closure (Day 0)Population: Full Analysis Set
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Duration of Surgery
|
74.5 minutes
Standard Deviation 19.73
|
76.9 minutes
Standard Deviation 17.33
|
SECONDARY outcome
Timeframe: Intra-operatively (Day 0) thru Postoperative Day 3Population: Full Analysis Set - participants with transfusion requirement
Outcome measures
| Measure |
Standard of Care (SoC)
n=10 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=12 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Transfusion Requirements - Packed Red Blood Cells
|
484.0 mL
Standard Deviation 173.54
|
403.3 mL
Standard Deviation 157.90
|
SECONDARY outcome
Timeframe: 1 day post-operativelyPopulation: Full Analysis Set
Outcome measures
| Measure |
Standard of Care (SoC)
n=49 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Total Drain Output at Day 1 Post-operatively
|
839.6 mL
Standard Deviation 476.38
|
647.3 mL
Standard Deviation 338.96
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6Population: Full Analysis Set
Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis. While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary.
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Pain Management - Number of Days When Pain Medication Was Used
All pain medications
|
28.7 days
Standard Deviation 13.71
|
31.9 days
Standard Deviation 12.72
|
|
Pain Management - Number of Days When Pain Medication Was Used
Narcotics
|
25.1 days
Standard Deviation 13.66
|
30.3 days
Standard Deviation 12.84
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6Population: Full Analysis Set
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Scores
Baseline (N= 50, 47)
|
4.9 score on a scale
Standard Deviation 3.03
|
4.4 score on a scale
Standard Deviation 2.76
|
|
Visual Analogue Scale (VAS) Pain Scores
Day 3 Postoperative (N= 45, 42)
|
3.2 score on a scale
Standard Deviation 2.60
|
4.1 score on a scale
Standard Deviation 2.43
|
|
Visual Analogue Scale (VAS) Pain Scores
Week 1 Postoperative (N= 40, 40)
|
4.4 score on a scale
Standard Deviation 2.13
|
4.8 score on a scale
Standard Deviation 2.08
|
|
Visual Analogue Scale (VAS) Pain Scores
Week 2 Postoperative (N= 40, 42)
|
3.0 score on a scale
Standard Deviation 1.87
|
3.8 score on a scale
Standard Deviation 2.12
|
|
Visual Analogue Scale (VAS) Pain Scores
Week 6 Postoperative (N= 49, 46)
|
1.3 score on a scale
Standard Deviation 1.34
|
2.4 score on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3Population: Full Analysis Set
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Outcome measures
| Measure |
Standard of Care (SoC)
n=45 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=42 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3
|
-1.6 score on a scale
Standard Deviation 3.18
|
-0.1 score on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1Population: Full Analysis Set
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Outcome measures
| Measure |
Standard of Care (SoC)
n=40 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=40 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1
|
-0.4 score on a scale
Standard Deviation 2.88
|
0.4 score on a scale
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2Population: Full Analysis Set
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Outcome measures
| Measure |
Standard of Care (SoC)
n=40 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=42 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2
|
-1.8 score on a scale
Standard Deviation 2.64
|
-0.5 score on a scale
Standard Deviation 3.18
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6Population: Full Analysis Set
Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.
Outcome measures
| Measure |
Standard of Care (SoC)
n=49 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=46 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6
|
-3.5 score on a scale
Standard Deviation 2.65
|
-2.1 score on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6Population: Full Analysis Set
A well-validated scale to reflect problems in people with lower limb issues. 1. Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain) 2. Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness) 3. Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues) Postoperative (Postop)
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 2 Post-op: Total Score (N= 25, 28)
|
72.5 score on a scale
Standard Deviation 33.24
|
99.6 score on a scale
Standard Deviation 50.09
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Baseline: Pain (N= 50, 47)
|
26.8 score on a scale
Standard Deviation 11.81
|
27.6 score on a scale
Standard Deviation 10.69
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Baseline: Stiffness (N= 50, 47)
|
11.9 score on a scale
Standard Deviation 4.86
|
11.6 score on a scale
Standard Deviation 5.31
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Baseline: Physical Functioning (N= 47, 43)
|
91.3 score on a scale
Standard Deviation 37.75
|
92.3 score on a scale
Standard Deviation 34.51
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Baseline: Average (N= 47, 43)
|
5.4 score on a scale
Standard Deviation 2.18
|
5.5 score on a scale
Standard Deviation 1.97
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Baseline: Total Score (N= 47, 43)
|
129.7 score on a scale
Standard Deviation 52.27
|
130.9 score on a scale
Standard Deviation 47.36
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Day 3 Postoperative: Pain (N= 46, 42)
|
19.1 score on a scale
Standard Deviation 11.87
|
21.5 score on a scale
Standard Deviation 10.28
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Day 3 Postoperative: Stiffness (N= 46, 42)
|
10.2 score on a scale
Standard Deviation 4.64
|
11.1 score on a scale
Standard Deviation 3.37
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Day 3 Post-op: Physical Functioning (N= 15, 16)
|
91.7 score on a scale
Standard Deviation 37.90
|
97.8 score on a scale
Standard Deviation 37.85
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Day 3 Post-op: Average (N= 15, 16)
|
5.2 score on a scale
Standard Deviation 2.12
|
5.6 score on a scale
Standard Deviation 2.05
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Day 3 Post-op: Total Score (N= 15, 16)
|
124.7 score on a scale
Standard Deviation 50.99
|
133.9 score on a scale
Standard Deviation 49.17
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 1 Post-op: Pain (N= 41, 41)
|
23.5 score on a scale
Standard Deviation 11.54
|
24.5 score on a scale
Standard Deviation 11.25
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 1 Post-op: Stiffness (N= 41, 40)
|
11.8 score on a scale
Standard Deviation 4.57
|
12.2 score on a scale
Standard Deviation 4.48
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 1 Post-op: Physical Functioning (N= 18, 24)
|
77.0 score on a scale
Standard Deviation 37.77
|
76.7 score on a scale
Standard Deviation 41.11
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 1 Post-op: Average (N= 18, 24)
|
4.7 score on a scale
Standard Deviation 2.18
|
4.7 score on a scale
Standard Deviation 2.19
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 1 Post-op: Total Score (N= 18, 24)
|
112.3 score on a scale
Standard Deviation 52.42
|
112.3 score on a scale
Standard Deviation 52.66
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 2 Post-op: Pain (N= 41, 43)
|
15.4 score on a scale
Standard Deviation 8.07
|
19.9 score on a scale
Standard Deviation 11.04
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 2 Post-op: Stiffness (N= 41, 42)
|
8.1 score on a scale
Standard Deviation 4.00
|
10.2 score on a scale
Standard Deviation 4.07
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 2 Post-op: Physical Functioning (N= 26, 28)
|
51.3 score on a scale
Standard Deviation 25.74
|
68.5 score on a scale
Standard Deviation 37.20
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 2 Post-op: Average (N= 25, 28)
|
3.0 score on a scale
Standard Deviation 1.39
|
4.1 score on a scale
Standard Deviation 2.09
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 6 Post-op: Pain (N= 49, 47)
|
8.5 score on a scale
Standard Deviation 7.60
|
12.6 score on a scale
Standard Deviation 7.98
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 6 Post-op: Stiffness (N= 49, 46)
|
5.5 score on a scale
Standard Deviation 3.64
|
7.7 score on a scale
Standard Deviation 3.96
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 6 Post-op: Physical Functioning (N= 43, 43)
|
27.5 score on a scale
Standard Deviation 25.78
|
39.9 score on a scale
Standard Deviation 26.98
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 6 Post-op: Average (N= 43, 42)
|
1.7 score on a scale
Standard Deviation 1.51
|
2.5 score on a scale
Standard Deviation 1.52
|
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Week 6 Post-op: Total Score (N= 43, 42)
|
41.6 score on a scale
Standard Deviation 36.24
|
61.1 score on a scale
Standard Deviation 36.56
|
SECONDARY outcome
Timeframe: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6Population: Full Analysis Set
A well-validated scale to reflect problems in people with lower limb issues. 1. Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain) 2. Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness) 3. Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues). Postoperative (Postop)
Outcome measures
| Measure |
Standard of Care (SoC)
n=49 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Day 3: Pain (N= 46, 42)
|
-7.3 score on a scale
Standard Deviation 12.72
|
-5.1 score on a scale
Standard Deviation 12.43
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Day 3: Stiffness (N= 46, 42)
|
-1.7 score on a scale
Standard Deviation 5.79
|
-0.1 score on a scale
Standard Deviation 4.90
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Day 3: Physical Functioning (N= 15, 16)
|
4.7 score on a scale
Standard Deviation 39.93
|
17.0 score on a scale
Standard Deviation 39.37
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Day 3: Average (N= 15, 16)
|
-0.0 score on a scale
Standard Deviation 2.15
|
0.8 score on a scale
Standard Deviation 2.28
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Day 3: Total Score (N= 15, 16)
|
0.0 score on a scale
Standard Deviation 51.66
|
19.2 score on a scale
Standard Deviation 54.70
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 1: Pain (N= 41, 41)
|
-3.2 score on a scale
Standard Deviation 11.54
|
-3.2 score on a scale
Standard Deviation 10.23
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 1: Stiffness (N= 41, 40)
|
-0.2 score on a scale
Standard Deviation 6.36
|
0.5 score on a scale
Standard Deviation 6.05
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 1: Physical Functioning (N= 18, 24)
|
-16.7 score on a scale
Standard Deviation 42.58
|
-7.3 score on a scale
Standard Deviation 44.39
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 1: Average (N= 18, 24)
|
-0.9 score on a scale
Standard Deviation 2.38
|
-0.3 score on a scale
Standard Deviation 2.28
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 1: Total Score (N= 18, 24)
|
-22.0 score on a scale
Standard Deviation 57.04
|
-6.2 score on a scale
Standard Deviation 54.60
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 2: Pain (N= 41, 43)
|
-11.2 score on a scale
Standard Deviation 10.90
|
-7.8 score on a scale
Standard Deviation 11.98
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 2: Stiffness (N= 41, 42)
|
-3.8 score on a scale
Standard Deviation 5.84
|
-1.7 score on a scale
Standard Deviation 6.39
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 2: Physical Functioning (N= 26, 28)
|
-40.3 score on a scale
Standard Deviation 33.65
|
-18.7 score on a scale
Standard Deviation 43.74
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 2: Average (N= 25, 28)
|
-2.3 score on a scale
Standard Deviation 1.95
|
-1.0 score on a scale
Standard Deviation 2.39
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 2: Total Score (N= 25, 28)
|
-55.5 score on a scale
Standard Deviation 46.91
|
-24.5 score on a scale
Standard Deviation 57.34
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 6: Pain (N= 49, 47)
|
-18.3 score on a scale
Standard Deviation 10.46
|
-15.0 score on a scale
Standard Deviation 12.10
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 6: Stiffness (N= 49, 46)
|
-6.5 score on a scale
Standard Deviation 5.54
|
-4.0 score on a scale
Standard Deviation 6.34
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 6: Physical Functioning (N= 42, 40)
|
-63.6 score on a scale
Standard Deviation 38.27
|
-48.9 score on a scale
Standard Deviation 33.69
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 6: Average (N= 42, 39)
|
-3.6 score on a scale
Standard Deviation 2.16
|
-2.8 score on a scale
Standard Deviation 1.95
|
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Change Week 6: Total Score (N= 42, 39)
|
-87.0 score on a scale
Standard Deviation 51.80
|
-66.5 score on a scale
Standard Deviation 46.90
|
SECONDARY outcome
Timeframe: Preoperative, and Postoperative Weeks 1, 2, and 6Population: Full Analysis Set
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline VT (N= 49, 47)
|
47.9 Scores on a scale
Standard Deviation 10.73
|
47.3 Scores on a scale
Standard Deviation 9.98
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline RE (N= 49, 47)
|
40.7 Scores on a scale
Standard Deviation 14.11
|
45.8 Scores on a scale
Standard Deviation 14.29
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline MH (N= 49, 47)
|
48.9 Scores on a scale
Standard Deviation 10.25
|
50.2 Scores on a scale
Standard Deviation 10.32
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline PF (N= 49, 47)
|
24.9 Scores on a scale
Standard Deviation 6.37
|
25.8 Scores on a scale
Standard Deviation 7.81
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline SF (N= 50, 47)
|
42.1 Scores on a scale
Standard Deviation 11.73
|
44.9 Scores on a scale
Standard Deviation 12.18
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: MH (N= 40, 40)
|
48.0 Scores on a scale
Standard Deviation 10.35
|
50.0 Scores on a scale
Standard Deviation 9.96
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: PF (N= 40, 38)
|
26.0 Scores on a scale
Standard Deviation 8.40
|
24.3 Scores on a scale
Standard Deviation 7.06
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: BP (N= 40, 42)
|
38.8 Scores on a scale
Standard Deviation 7.34
|
35.1 Scores on a scale
Standard Deviation 6.01
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: RE (N= 35, 41)
|
38.9 Scores on a scale
Standard Deviation 15.81
|
40.2 Scores on a scale
Standard Deviation 15.97
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: PF (N= 47, 46)
|
37.0 Scores on a scale
Standard Deviation 11.13
|
34.0 Scores on a scale
Standard Deviation 9.75
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: RP (N= 49, 47)
|
41.8 Scores on a scale
Standard Deviation 11.05
|
38.8 Scores on a scale
Standard Deviation 11.03
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: BP (N= 49, 47)
|
47.7 Scores on a scale
Standard Deviation 9.20
|
43.9 Scores on a scale
Standard Deviation 8.43
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: GH (N= 49, 47)
|
54.2 Scores on a scale
Standard Deviation 6.41
|
52.7 Scores on a scale
Standard Deviation 9.44
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: VT (N= 49, 47)
|
53.4 Scores on a scale
Standard Deviation 10.31
|
49.1 Scores on a scale
Standard Deviation 9.63
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: SF (N= 49, 47)
|
48.2 Scores on a scale
Standard Deviation 10.50
|
47.3 Scores on a scale
Standard Deviation 10.94
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: RE (N= 49, 47)
|
46.5 Scores on a scale
Standard Deviation 12.52
|
46.5 Scores on a scale
Standard Deviation 12.57
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: MH (N= 49, 47)
|
54.0 Scores on a scale
Standard Deviation 8.96
|
52.3 Scores on a scale
Standard Deviation 11.24
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: PCS (N= 47, 46)
|
41.7 Scores on a scale
Standard Deviation 8.87
|
38.1 Scores on a scale
Standard Deviation 9.29
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 6: MCS (N= 47, 46)
|
54.5 Scores on a scale
Standard Deviation 8.96
|
55.1 Scores on a scale
Standard Deviation 11.32
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline RP (N= 50, 47)
|
32.9 Scores on a scale
Standard Deviation 10.87
|
33.5 Scores on a scale
Standard Deviation 11.06
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline BP (N= 50, 47)
|
35.5 Scores on a scale
Standard Deviation 7.58
|
36.2 Scores on a scale
Standard Deviation 9.21
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline GH (N= 49, 47)
|
52.3 Scores on a scale
Standard Deviation 6.34
|
50.2 Scores on a scale
Standard Deviation 9.83
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline PCS (N= 48, 47)
|
31.4 Scores on a scale
Standard Deviation 7.11
|
30.3 Scores on a scale
Standard Deviation 8.41
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Baseline MCS (N= 48, 47)
|
52.3 Scores on a scale
Standard Deviation 12.46
|
55.2 Scores on a scale
Standard Deviation 12.28
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: PF (N= 39, 37)
|
23.1 Scores on a scale
Standard Deviation 7.88
|
22.9 Scores on a scale
Standard Deviation 8.16
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: RP (N= 38, 37)
|
25.3 Scores on a scale
Standard Deviation 8.02
|
26.5 Scores on a scale
Standard Deviation 9.99
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: BP (N= 40, 40)
|
33.9 Scores on a scale
Standard Deviation 7.99
|
33.1 Scores on a scale
Standard Deviation 8.09
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: GH (N= 41, 40)
|
52.9 Scores on a scale
Standard Deviation 5.43
|
50.1 Scores on a scale
Standard Deviation 10.09
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: VT (N= 40, 40)
|
43.3 Scores on a scale
Standard Deviation 11.02
|
42.0 Scores on a scale
Standard Deviation 10.64
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: SF (N= 40, 40)
|
33.0 Scores on a scale
Standard Deviation 12.70
|
37.1 Scores on a scale
Standard Deviation 14.12
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: RE (N= 37, 38)
|
36.8 Scores on a scale
Standard Deviation 17.03
|
39.5 Scores on a scale
Standard Deviation 17.97
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: PCS (N= 36, 37)
|
28.4 Scores on a scale
Standard Deviation 7.26
|
26.6 Scores on a scale
Standard Deviation 7.16
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 1: MCS (N= 36, 37)
|
47.9 Scores on a scale
Standard Deviation 12.38
|
51.1 Scores on a scale
Standard Deviation 13.18
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: RP (N= 36, 42)
|
28.1 Scores on a scale
Standard Deviation 9.47
|
26.7 Scores on a scale
Standard Deviation 7.35
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: GH (N= 40, 42)
|
52.4 Scores on a scale
Standard Deviation 6.91
|
51.9 Scores on a scale
Standard Deviation 9.59
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: VT (N= 40, 42)
|
47.6 Scores on a scale
Standard Deviation 6.55
|
45.8 Scores on a scale
Standard Deviation 10.60
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: SF (N= 40, 42)
|
39.4 Scores on a scale
Standard Deviation 9.50
|
37.6 Scores on a scale
Standard Deviation 12.82
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: MH (N= 40, 42)
|
50.7 Scores on a scale
Standard Deviation 10.18
|
51.5 Scores on a scale
Standard Deviation 10.32
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: PCS (N= 33, 37)
|
30.5 Scores on a scale
Standard Deviation 7.72
|
27.8 Scores on a scale
Standard Deviation 7.33
|
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Change Week 2: MCS (N= 33, 37)
|
51.7 Scores on a scale
Standard Deviation 13.00
|
53.2 Scores on a scale
Standard Deviation 10.89
|
SECONDARY outcome
Timeframe: Baseline and Postoperative Weeks 1, 2, and 6Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available. Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) - (Baseline Scores).
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: PF (N= 38, 37)
|
-2.1 Scores on a scale
Standard Deviation 10.18
|
-2.7 Scores on a scale
Standard Deviation 9.09
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: RP (N= 38, 37)
|
-8.0 Scores on a scale
Standard Deviation 10.05
|
-6.6 Scores on a scale
Standard Deviation 11.39
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: BP (N= 40, 40)
|
-2.3 Scores on a scale
Standard Deviation 10.93
|
-3.4 Scores on a scale
Standard Deviation 9.65
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: GH (N= 40, 40)
|
0.1 Scores on a scale
Standard Deviation 6.23
|
-1.1 Scores on a scale
Standard Deviation 7.68
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: VT (N= 39, 40)
|
-5.9 Scores on a scale
Standard Deviation 9.66
|
-5.7 Scores on a scale
Standard Deviation 11.81
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: SF (N= 40, 40)
|
-10.8 Scores on a scale
Standard Deviation 12.75
|
-6.7 Scores on a scale
Standard Deviation 15.30
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: RE (N= 36, 38)
|
-3.9 Scores on a scale
Standard Deviation 16.85
|
-6.2 Scores on a scale
Standard Deviation 20.12
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: MH (N= 39, 40)
|
-2.3 Scores on a scale
Standard Deviation 10.79
|
-0.4 Scores on a scale
Standard Deviation 11.26
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: PCS (N= 34, 37)
|
-3.8 Scores on a scale
Standard Deviation 8.97
|
-3.5 Scores on a scale
Standard Deviation 7.73
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 1: MCS (N= 34, 37)
|
-5.1 Scores on a scale
Standard Deviation 10.60
|
-4.1 Scores on a scale
Standard Deviation 14.13
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: PF (N= 39, 38)
|
1.1 Scores on a scale
Standard Deviation 10.21
|
-1.2 Scores on a scale
Standard Deviation 7.07
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: RP (N= 36, 42)
|
-4.6 Scores on a scale
Standard Deviation 12.48
|
-6.9 Scores on a scale
Standard Deviation 9.08
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: BP (N= 40, 42)
|
2.8 Scores on a scale
Standard Deviation 7.90
|
-1.4 Scores on a scale
Standard Deviation 9.39
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: GH (N= 39, 42)
|
-0.0 Scores on a scale
Standard Deviation 6.26
|
1.0 Scores on a scale
Standard Deviation 8.92
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: VT (N= 39, 42)
|
-0.5 Scores on a scale
Standard Deviation 9.07
|
-2.1 Scores on a scale
Standard Deviation 12.39
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: SF (N= 40, 42)
|
-3.5 Scores on a scale
Standard Deviation 10.95
|
-6.4 Scores on a scale
Standard Deviation 13.14
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: RE (N= 34, 41)
|
-0.7 Scores on a scale
Standard Deviation 16.89
|
-6.6 Scores on a scale
Standard Deviation 16.08
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: MH (N= 39, 42)
|
0.8 Scores on a scale
Standard Deviation 12.36
|
0.5 Scores on a scale
Standard Deviation 12.83
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: PCS (N= 32, 37)
|
-0.9 Scores on a scale
Standard Deviation 7.76
|
-2.4 Scores on a scale
Standard Deviation 6.89
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 2: MCS (N= 32, 37)
|
0.3 Scores on a scale
Standard Deviation 12.90
|
-2.0 Scores on a scale
Standard Deviation 12.83
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: PF (N= 46, 46)
|
12.0 Scores on a scale
Standard Deviation 11.34
|
8.0 Scores on a scale
Standard Deviation 7.89
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: RP (N= 49, 47)
|
8.7 Scores on a scale
Standard Deviation 14.84
|
5.4 Scores on a scale
Standard Deviation 12.20
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: BP (N= 49, 47)
|
12.3 Scores on a scale
Standard Deviation 10.43
|
7.7 Scores on a scale
Standard Deviation 10.00
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: GH (N= 48, 47)
|
1.9 Scores on a scale
Standard Deviation 6.33
|
2.5 Scores on a scale
Standard Deviation 9.73
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: VT (N= 48, 47)
|
5.7 Scores on a scale
Standard Deviation 15.00
|
1.8 Scores on a scale
Standard Deviation 11.95
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: SF (N= 49, 47)
|
5.8 Scores on a scale
Standard Deviation 14.62
|
2.4 Scores on a scale
Standard Deviation 13.64
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: RE (N= 48, 47)
|
5.9 Scores on a scale
Standard Deviation 17.20
|
0.7 Scores on a scale
Standard Deviation 14.76
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: MH (N= 48, 47)
|
5.2 Scores on a scale
Standard Deviation 11.90
|
2.1 Scores on a scale
Standard Deviation 14.52
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: PCS (N= 45, 46)
|
10.4 Scores on a scale
Standard Deviation 10.43
|
7.8 Scores on a scale
Standard Deviation 8.62
|
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Change Week 6: MCS (N= 45, 46)
|
2.1 Scores on a scale
Standard Deviation 12.53
|
-0.2 Scores on a scale
Standard Deviation 13.97
|
SECONDARY outcome
Timeframe: From the day of hospitalization to the day of dischargePopulation: Full Analysis Set
Outcome measures
| Measure |
Standard of Care (SoC)
n=50 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=47 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Length of Hospital Stay
|
3.52 Days
Standard Deviation 0.857
|
3.38 Days
Standard Deviation 0.918
|
SECONDARY outcome
Timeframe: Intra-operativePopulation: Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
Outcome measures
| Measure |
Standard of Care (SoC)
n=65 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=53 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Proportion of Participants With Transfusion Requirements
|
0.25 Proportion of participants
Interval 0.148 to 0.369
|
0.19 Proportion of participants
Interval 0.094 to 0.32
|
SECONDARY outcome
Timeframe: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6Population: Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
Outcome measures
| Measure |
Standard of Care (SoC)
n=65 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=53 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)
|
0.03 Proportion of participants
Interval 0.004 to 0.107
|
0.06 Proportion of participants
Interval 0.012 to 0.157
|
SECONDARY outcome
Timeframe: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6Population: Safety Analysis Set Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants
Outcome measures
| Measure |
Standard of Care (SoC)
n=65 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=53 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery
|
0.26 Proportion of participants
Interval 0.16 to 0.385
|
0.36 Proportion of participants
Interval 0.231 to 0.502
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=45 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=49 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 1 (N= 45, 48)
|
24 participants
|
22 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 2 (N= 45, 49)
|
42 participants
|
47 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 3 (N= 44, 49)
|
43 participants
|
48 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 4 (N= 45, 47)
|
41 participants
|
46 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 5 (N= 39, 42)
|
27 participants
|
31 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 6 (N= 35, 39)
|
17 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 7 (N= 37, 39)
|
20 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 8 (N= 37, 42)
|
19 participants
|
24 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 9 (N= 35, 39)
|
13 participants
|
19 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 10 (N= 32, 38)
|
17 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 11 (N= 35, 41)
|
12 participants
|
21 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 12 (N= 34, 37)
|
10 participants
|
19 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 13 (N= 36, 38)
|
14 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 14 (N= 39, 36)
|
15 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 15 (N= 39, 41)
|
21 participants
|
24 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 16 (N= 39, 41)
|
16 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 17 (N= 37, 41)
|
20 participants
|
21 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 18 (N= 38, 41)
|
13 participants
|
21 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 19 (N= 40, 40)
|
18 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 20 (N= 38, 40)
|
4 participants
|
9 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 21 (N= 38, 40)
|
16 participants
|
10 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 22 (N= 38, 41)
|
12 participants
|
14 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 23 (N= 38, 39)
|
14 participants
|
10 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 24 (N= 39, 39)
|
8 participants
|
12 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 25 (N= 37, 40)
|
9 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 26 (N= 38, 39)
|
8 participants
|
9 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 27 (N= 38, 38)
|
3 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 28 (N= 37, 39)
|
9 participants
|
8 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 29 (N= 38, 39)
|
15 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 30 (N= 36, 40)
|
10 participants
|
17 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 31 (N= 35, 40)
|
7 participants
|
10 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 32 (N= 37, 40)
|
13 participants
|
14 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 33 (N= 37, 39)
|
8 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 34 (N= 37, 39)
|
7 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 35 (N= 38, 39)
|
13 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 36 (N= 38, 39)
|
15 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 37 (N= 35, 38)
|
10 participants
|
10 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 38 (N= 35, 41)
|
9 participants
|
12 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 39 (N= 36, 39)
|
11 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 40 (N= 37, 40)
|
11 participants
|
11 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 41 (N= 32, 36)
|
2 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 42 (N= 30, 35)
|
7 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 43 (N= 25, 31)
|
9 participants
|
12 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 44 (N= 6, 7)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 45 (N= 3, 4)
|
2 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 46 (N= 3, 2)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 47 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 49 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 52 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 53 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 55 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=47 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=50 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 49 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 1 (N= 47, 50)
|
1 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 2 (N= 47, 50)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 3 (N= 46, 50)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 4 (N= 46, 48)
|
0 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 5 (N= 42, 44)
|
5 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 6 (N= 40, 42)
|
7 participants
|
4 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 7 (N= 40, 42)
|
8 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 8 (N= 38, 42)
|
6 participants
|
4 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 9 (N= 37, 41)
|
5 participants
|
7 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 10 (N= 34, 40)
|
5 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 11 (N= 36, 41)
|
7 participants
|
8 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 12 (N= 36, 39)
|
8 participants
|
10 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 13 (N= 38, 39)
|
9 participants
|
11 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 14 (N= 39, 39)
|
10 participants
|
11 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 15 (N= 40, 42)
|
9 participants
|
14 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 16 (N= 40, 41)
|
10 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 17 (N= 38, 41)
|
10 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 18 (N= 40, 41)
|
10 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 19 (N= 41, 41)
|
12 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 20 (N= 40, 40)
|
14 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 21 (N= 39, 40)
|
14 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 22 (N= 39, 41)
|
15 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 23 (N= 39, 40)
|
16 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 24 (N= 40, 39)
|
16 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 25 (N= 39, 40)
|
17 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 26 (N= 39, 39)
|
18 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 27 (N= 39, 39)
|
18 participants
|
21 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 28 (N= 38, 39)
|
19 participants
|
22 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 29 (N= 38, 39)
|
19 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 30 (N= 36, 40)
|
20 participants
|
26 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 31 (N= 37, 40)
|
21 participants
|
27 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 32 (N= 37, 40)
|
23 participants
|
25 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 33 (N= 38, 39)
|
23 participants
|
27 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 34 (N= 37, 39)
|
23 participants
|
27 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 35 (N= 38, 39)
|
23 participants
|
28 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 36 (N= 38, 40)
|
22 participants
|
29 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 37 (N= 36, 39)
|
23 participants
|
28 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 38 (N= 36, 41)
|
24 participants
|
30 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 39 (N= 36, 39)
|
24 participants
|
29 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 40 (N= 37, 40)
|
25 participants
|
30 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 41 (N= 32, 36)
|
23 participants
|
27 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 42 (N= 31, 35)
|
22 participants
|
26 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 43 (N= 25, 31)
|
18 participants
|
24 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 44 (N= 6, 8)
|
5 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 45 (N= 3, 4)
|
2 participants
|
4 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 46 (N= 3, 2)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 47 (N= 1, 1)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 52 (N= 1, 1)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 53(N= 1, 1)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 55 (N= 1, 1)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
1 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=47 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=50 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 32 (N= 37, 40)
|
8 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 33 (N= 38, 39)
|
6 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 34 (N= 37, 39)
|
5 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 35 (N= 38, 39)
|
6 participants
|
7 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 36 (N= 38, 40)
|
5 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 40 (N= 37, 40)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 41 (N= 32, 36)
|
2 participants
|
4 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 42 (N= 31, 35)
|
2 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 37 (N= 36, 39)
|
3 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 38 (N= 36, 41)
|
4 participants
|
4 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 39 (N= 36, 39)
|
3 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 9 (N= 37, 41)
|
26 participants
|
34 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 10 (N= 34, 40)
|
23 participants
|
33 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 11 (N= 36, 41)
|
24 participants
|
32 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 12 (N= 36, 39)
|
24 participants
|
27 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 13 (N= 38, 39)
|
26 participants
|
22 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 14 (N= 39, 39)
|
23 participants
|
21 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 15 (N= 40, 42)
|
19 participants
|
22 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 16 (N= 40, 41)
|
19 participants
|
23 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 17 (N= 38, 41)
|
17 participants
|
21 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 18 (N= 40, 41)
|
17 participants
|
22 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 19 (N= 41,41 )
|
20 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 20 (N= 40, 40)
|
15 participants
|
19 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 21 (N= 39, 40)
|
15 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 22 (N= 39, 41)
|
12 participants
|
17 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 23 (N= 39, 40)
|
12 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 24 (N= 40, 39)
|
12 participants
|
14 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 25 (N= 39, 40)
|
8 participants
|
11 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 26 (N= 39, 39)
|
9 participants
|
9 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 27 (N= 39, 39)
|
8 participants
|
7 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 28 (N= 38, 39)
|
9 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 29 (N= 38, 39)
|
8 participants
|
7 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 30 (N= 36, 40)
|
5 participants
|
7 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 31 (N= 37, 40)
|
5 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 1 (N= 47, 50)
|
17 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 2 (N= 47, 50)
|
39 participants
|
41 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 3 (N= 46, 50)
|
38 participants
|
46 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 4 (N= 46, 48)
|
38 participants
|
44 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 5 (N= 42, 44)
|
33 participants
|
40 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 6 (N= 40, 42)
|
34 participants
|
38 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 7 (N= 40, 42)
|
32 participants
|
38 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 8 (N= 38, 42)
|
31 participants
|
36 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 43 (N= 25, 31)
|
1 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 44 (N= 6, 8)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 45 (N= 3, 4)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 46 (N= 3, 2)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 47 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 49(N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 52 (N= 1, 1)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 53 (N= 1, 1)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 55 (N= 1, 1)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=47 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=50 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 1 (N= 47, 50)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 2 (N= 47, 50)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 3 (N= 46, 50)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 4 (N= 46, 48)
|
1 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 5 (N= 42, 44)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 6 (N= 40, 42)
|
2 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 7 (N= 40, 42)
|
2 participants
|
4 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 8 (N= 38, 42)
|
2 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 9 (N= 37, 41)
|
5 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 10 (N= 34, 40)
|
6 participants
|
6 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 11 (N= 36, 41)
|
9 participants
|
7 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 12 (N= 36, 39)
|
11 participants
|
10 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 13 (N= 38, 39)
|
12 participants
|
14 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 14 (N= 39, 39)
|
16 participants
|
12 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 15 (N= 40, 42)
|
18 participants
|
14 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 16 (N= 40, 41)
|
20 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 17 (N= 38, 41)
|
19 participants
|
17 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 18 (N= 40, 41)
|
19 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 19 (N= 41, 41)
|
18 participants
|
19 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 20 (N= 40, 40)
|
18 participants
|
22 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 21 (N= 39, 40)
|
17 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 22 (N= 39, 41)
|
20 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 23 (N= 39, 40)
|
20 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 24 (N= 40, 39)
|
20 participants
|
17 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 25 (N= 39, 40)
|
19 participants
|
19 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 26 (N= 39, 39)
|
21 participants
|
21 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 27 (N= 39, 39)
|
18 participants
|
20 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 28 (N= 38, 39)
|
18 participants
|
19 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 29 (N= 38, 39)
|
17 participants
|
19 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 30 (N= 36, 40)
|
16 participants
|
17 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 31 (N= 37, 40)
|
17 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 32 (N= 37, 40)
|
14 participants
|
18 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 33 (N= 38, 39)
|
15 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 34 (N= 37, 39)
|
15 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 35 (N= 38, 39)
|
14 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 36 (N= 38, 40)
|
15 participants
|
17 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 37 (N= 36, 39)
|
13 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 38 (N= 36, 41)
|
10 participants
|
16 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 39 (N= 36, 39)
|
13 participants
|
14 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 40 (N= 37, 40)
|
11 participants
|
15 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 41 (N= 32, 36)
|
9 participants
|
11 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 42 (N= 31, 35)
|
7 participants
|
11 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 43 (N= 25, 31)
|
7 participants
|
9 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 44 (N= 6, 8)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 45 (N= 3, 4)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 46 (N= 3, 2)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 47 (N= 1, 1)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 49 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 52 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 53 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 55 (N= 1, 1)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=47 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=50 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 41 (N= 32, 36)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 42 (N= 31, 35)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 52 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 53(N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 55 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 1 (N= 47, 50)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 2 (N= 47, 50)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 3 (N= 46, 50)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 4 (N= 46, 48)
|
2 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 5 (N= 42, 44)
|
7 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 6 (N= 40, 42)
|
5 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 7 (N= 40, 42)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 8 (N= 38, 42)
|
6 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 9 (N= 37, 41)
|
5 participants
|
4 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 10 (N= 34, 40)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 11 (N= 36, 41)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 12 (N= 36, 39)
|
3 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 13 (N= 38, 39)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 14 (N= 39, 39)
|
3 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 15 (N= 40, 42)
|
4 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 16 (N= 40, 41)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 17 (N= 38, 41)
|
4 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 18 (N= 40, 41)
|
3 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 19 (N= 41, 41)
|
4 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 20 (N= 40, 40)
|
3 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 21 (N= 39, 40)
|
2 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 22 (N= 39, 41)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 23 (N= 39, 40)
|
3 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 24 (N= 40, 39)
|
2 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 25 (N= 39, 40)
|
3 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 26 (N= 39, 39)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 27 (N= 39, 39)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 28 (N= 38, 39)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 29 (N= 38, 39)
|
2 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 30 (N= 36, 40)
|
2 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 31 (N= 37, 40)
|
2 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 32 (N= 37, 40)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 33 (N= 38, 39)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 34 (N= 37, 39)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 35 (N= 38, 39)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 36 (N= 38, 40)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 37 (N= 36, 39)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 38 (N= 36, 41)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 39 (N= 36, 39)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 40 (N= 37, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 43 (N= 25, 31)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 44 (N= 6,8 )
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 45 (N= 3, 4)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 46 (N= 3, 2)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 47 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Day 49 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=47 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=50 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 22 (N= 39, 41)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 1 (N= 47, 50)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 2 (N= 47, 50)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 3 (N= 46, 50)
|
3 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 4 (N= 46, 48)
|
4 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 5 (N= 42, 44)
|
6 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 6 (N= 40, 42)
|
4 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 7 (N= 40, 42)
|
6 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 8 (N= 38, 42)
|
5 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 9 (N= 37, 41)
|
5 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 10 (N= 34, 40)
|
7 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 11 (N= 36, 41)
|
6 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 12 (N= 36, 39)
|
6 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 13 (N= 38, 39)
|
6 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 14 (N= 39, 39)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 15 (N= 40, 42)
|
5 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 16 (N= 40, 41)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 17 (N= 38, 41)
|
4 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 18 (N= 40, 41)
|
4 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 19 (N= 41, 41)
|
3 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 20 (N= 40, 40)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 21 (N= 39, 40)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 23 (N= 39, 40)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 24 (N= 40, 39)
|
4 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 25 (N= 39, 40)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 26 (N= 39, 39)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 27 (N= 39, 39)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 28 (N= 38, 39)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 29 (N= 38, 39)
|
1 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 30 (N= 36, 40)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 31 (N= 37, 40)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 32 (N= 37, 40)
|
1 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 33 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 34 (N= 37, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 35 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 36 (N= 38, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 37 (N= 36, 39)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 38 (N= 36, 41)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 39 (N= 36, 39)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 40 (N= 37, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 41 (N= 32, 36)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 42 (N= 31, 35)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 43 (N= 25, 31)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 44 (N= 6, 8)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 45 (N= 3, 4)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 46 (N= 3, 2)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 47 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 49 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 52 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 53 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 55 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=47 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=50 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 41 (N= 32, 36)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 1 (N= 47, 50)
|
23 participants
|
27 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 2 (N= 47, 50)
|
4 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 3 (N= 46, 50)
|
3 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 4 (N= 46, 48)
|
2 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 5 (N= 42, 44)
|
1 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 6 (N= 42, 42)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 7 (N= 40, 42)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 8 (N= 38, 42)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 9 (N= 37, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 10 (N= 34, 40)
|
1 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 11 (N= 36, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 12 (N= 36, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 13 (N= 38, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 14 (N= 39, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 15 (N= 40, 42)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 16 (N= 40, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 17 (N= 38, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 18 (N= 40, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 19 (N= 41, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 20 (N= 40, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 21 (N= 39, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 22 (N= 39, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 23 (N= 39, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 24 (N= 40, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 25 (N= 39, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 26 (N= 39, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 27 (N= 39, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 28 (N= 38, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 29 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 30 (N= 36, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 31 (N= 37, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 32 (N= 37, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 33 (N= 38, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 34 (N= 37, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 35 (N= 38, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 36 (N= 38, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 37 (N= 36, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 38 (N= 36, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 39 (N= 36, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 40 (N= 37, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 42 (N= 31, 35)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 43 (N= 25, 31)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 44 (N= 6, 8)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 45 (N= 3, 4)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 46 (N= 3, 2)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 47 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 49 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 52 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 53 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 55 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Full Analysis Set
The number of participants responding affirmative in their rehabilitation diaries for each day
Outcome measures
| Measure |
Standard of Care (SoC)
n=47 Participants
SoC: conventional hemostatic techniques such as cautery and manual compression
|
FLOSEAL + Standard of Care (SoC)
n=50 Participants
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
|---|---|---|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 58 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 1 (N= 47, 50)
|
2 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 2 (N= 47, 50)
|
13 participants
|
12 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 3 (N= 46, 50)
|
13 participants
|
13 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 4 (N= 46, 48)
|
10 participants
|
12 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 5 (N= 42, 44)
|
5 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 6 (N= 40, 42)
|
5 participants
|
5 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 7 (N= 40, 42)
|
4 participants
|
2 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 8 (N= 38, 42)
|
5 participants
|
3 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 9 (N= 37, 41)
|
4 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 10 (N= 34, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 11 (N= 36, 41)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 12 (N= 36, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 13 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 14 (N= 39, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 15 (N= 40, 42)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 16 (N= 40, 41)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 17 (N= 38, 41)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 18 (N= 40, 41)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 19 (N= 41,41 )
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 20 (N= 40, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 21 (N= 39, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 22 (N= 39, 41)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 23 (N= 39, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 24 (N= 40, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 25 (N= 39, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 26 (N= 39, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 27 (N= 39, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 28 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 29 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 30 (N= 36, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 31 (N= 37, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 32 (N= 37, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 33 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 34 (N= 37, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 35 (N= 38, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 36 (N= 38, 40)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 37 (N= 36, 39)
|
0 participants
|
1 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 38 (N= 36, 41)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 39 (N= 36, 39)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 40 (N= 37, 40)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 41 (N= 32, 36)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 42 (N= 31, 35)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 43 (N= 25, 31)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 44 (N= 6, 8)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 45 (N= 3, 4)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 46 (N= 3, 2)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 47 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 48 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 49 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 50 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 51 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 52 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 53 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 54 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 55 (N= 1, 1)
|
0 participants
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 56 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 57 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 59 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Day 60 (N= 0, 1)
|
NA participants
No participants provided a response/assessment to this parameter for this time point
|
0 participants
|
Adverse Events
FLOSEAL + Standard of Care (SoC)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard of Care (SoC)
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FLOSEAL + Standard of Care (SoC)
n=65 participants at risk
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
Standard of Care (SoC)
n=53 participants at risk
SoC: conventional hemostatic techniques such as cautery and manual compression
|
|---|---|---|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.5%
1/65 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
0.00%
0/53 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.5%
1/65 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
0.00%
0/53 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.5%
1/65 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
0.00%
0/53 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Surgical and medical procedures
CORONARY ARTERY BYPASS
|
0.00%
0/65 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
1.9%
1/53 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
1.5%
1/65 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
0.00%
0/53 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DISCHARGE
|
1.5%
1/65 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
0.00%
0/53 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
Other adverse events
| Measure |
FLOSEAL + Standard of Care (SoC)
n=65 participants at risk
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
|
Standard of Care (SoC)
n=53 participants at risk
SoC: conventional hemostatic techniques such as cautery and manual compression
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
1.5%
1/65 • Number of events 1 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
5.7%
3/53 • Number of events 3 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
|
Vascular disorders
Hypotension
|
6.2%
4/65 • Number of events 4 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
0.00%
0/53 • Throughout the study period 1 year and 4 months
The FLOSEAL + Standard of Care (SoC) arm/group includes the 12 Run-In participants. Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
|
Additional Information
Maurice Bagot D'Arc, MD, Sr Medical Director Medical Affairs , BioSurgery
Baxter BioScience
Results disclosure agreements
- Principal investigator is a sponsor employee Baxter's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥30 days prior to submission or communication. Baxter may request an additional delay of ≤60 days(e.g., for intellectual property protection)
- Publication restrictions are in place
Restriction type: OTHER