Trial Outcomes & Findings for Subchondroplasty® Knee RCT (NCT NCT03112200)
NCT ID: NCT03112200
Last Updated: 2026-05-14
Results Overview
The primary objective of this study is to determine whether Subchondroplasty with arthroscopy is superior to arthroscopy alone for treatment of bone marrow lesions in the knee. Superiority will be evaluated in terms of Composite Clinical Success (CCS) requiring freedom from subsequent secondary surgical intervention (SSSI) and among those free from SSSI, a clinically meaningful reduction in self-reported pain based on a validated measure of subject-reported pain (improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) pain of at least 10 points at 12 months). For the purpose of this study, SSSI will include any partial or total joint arthroplasty or any bone grafting or bone substitute procedure in the study knee.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
Superiority will be statistically tested at month 12 at p<0.01
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Subchondroplasty With Arthroscopy
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
43
|
|
Overall Study
COMPLETED
|
77
|
40
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
| Measure |
Subchondroplasty With Arthroscopy
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Overall Study
Failure
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Other
|
4
|
0
|
Baseline Characteristics
Subchondroplasty® Knee RCT
Baseline characteristics by cohort
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=1512 Participants
|
33 Participants
n=504 Participants
|
104 Participants
n=2016 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
27 Participants
n=2016 Participants
|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 9.0 • n=1512 Participants
|
58 years
STANDARD_DEVIATION 9.3 • n=504 Participants
|
57.5 years
STANDARD_DEVIATION 9.0 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=1512 Participants
|
19 Participants
n=504 Participants
|
66 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=1512 Participants
|
24 Participants
n=504 Participants
|
65 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Decline to Respond
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=1512 Participants
|
37 Participants
n=504 Participants
|
112 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=1512 Participants
|
3 participants
n=504 Participants
|
9 participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=1512 Participants
|
40 participants
n=504 Participants
|
122 participants
n=2016 Participants
|
|
KOOS Subscale Scores
Pain
|
42.5 units on a scale
STANDARD_DEVIATION 15.3 • n=1512 Participants
|
42.9 units on a scale
STANDARD_DEVIATION 15.0 • n=504 Participants
|
42.6 units on a scale
STANDARD_DEVIATION 15.2 • n=2016 Participants
|
|
KOOS Subscale Scores
Activities of Daily Living
|
47.4 units on a scale
STANDARD_DEVIATION 17.1 • n=1512 Participants
|
50.7 units on a scale
STANDARD_DEVIATION 19.4 • n=504 Participants
|
48.48 units on a scale
STANDARD_DEVIATION 17.88 • n=2016 Participants
|
|
KOOS Subscale Scores
Symptoms
|
48.4 units on a scale
STANDARD_DEVIATION 21.4 • n=1512 Participants
|
49.7 units on a scale
STANDARD_DEVIATION 18.5 • n=504 Participants
|
48.83 units on a scale
STANDARD_DEVIATION 20.50 • n=2016 Participants
|
|
KOOS Subscale Scores
Sports and Recreation
|
17.6 units on a scale
STANDARD_DEVIATION 20.2 • n=1512 Participants
|
17.6 units on a scale
STANDARD_DEVIATION 18.4 • n=504 Participants
|
17.6 units on a scale
STANDARD_DEVIATION 19.63 • n=2016 Participants
|
|
KOOS Subscale Scores
Quality of Life
|
17.3 units on a scale
STANDARD_DEVIATION 14.2 • n=1512 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 17.0 • n=504 Participants
|
18.05 units on a scale
STANDARD_DEVIATION 15.17 • n=2016 Participants
|
|
Numeric Pain Score
|
6.5 Score (0-10)
STANDARD_DEVIATION 1.8 • n=1512 Participants
|
5.9 Score (0-10)
STANDARD_DEVIATION 2.2 • n=504 Participants
|
6.3 Score (0-10)
STANDARD_DEVIATION 1.94 • n=2016 Participants
|
|
EQ-5D Index Score
|
0.1 Index Score
STANDARD_DEVIATION 0.3 • n=1512 Participants
|
0.2 Index Score
STANDARD_DEVIATION 0.4 • n=504 Participants
|
.13 Index Score
STANDARD_DEVIATION .34 • n=2016 Participants
|
|
Imaging Completed at Baseline
|
68 Participants
n=1512 Participants
|
33 Participants
n=504 Participants
|
101 Participants
n=2016 Participants
|
|
Number of Bone Lesions
1
|
59 Participants
n=1512 Participants
|
30 Participants
n=504 Participants
|
89 Participants
n=2016 Participants
|
|
Number of Bone Lesions
2
|
29 Participants
n=1512 Participants
|
13 Participants
n=504 Participants
|
42 Participants
n=2016 Participants
|
|
EQ-5D Overall Health
|
75.7 Points on a scale (0-100)
STANDARD_DEVIATION 16.8 • n=1512 Participants
|
76.0 Points on a scale (0-100)
STANDARD_DEVIATION 14.1 • n=504 Participants
|
75.8 Points on a scale (0-100)
STANDARD_DEVIATION 16.06 • n=2016 Participants
|
PRIMARY outcome
Timeframe: Superiority will be statistically tested at month 12 at p<0.01The primary objective of this study is to determine whether Subchondroplasty with arthroscopy is superior to arthroscopy alone for treatment of bone marrow lesions in the knee. Superiority will be evaluated in terms of Composite Clinical Success (CCS) requiring freedom from subsequent secondary surgical intervention (SSSI) and among those free from SSSI, a clinically meaningful reduction in self-reported pain based on a validated measure of subject-reported pain (improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) pain of at least 10 points at 12 months). For the purpose of this study, SSSI will include any partial or total joint arthroplasty or any bone grafting or bone substitute procedure in the study knee.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Composite Clinical Success
Yes
|
68 Participants
|
38 Participants
|
|
Composite Clinical Success
No
|
16 Participants
|
4 Participants
|
|
Composite Clinical Success
Did not answer
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months post-surgeryComparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Change From Baseline KOOS Subscale Scores at 12 Months
Pain
|
73.3 score on a scale
Standard Deviation 21.0
|
79.4 score on a scale
Standard Deviation 22.7
|
|
Change From Baseline KOOS Subscale Scores at 12 Months
Actibities of Daily Living
|
79.3 score on a scale
Standard Deviation 19.8
|
83.5 score on a scale
Standard Deviation 21.6
|
|
Change From Baseline KOOS Subscale Scores at 12 Months
Symptom
|
71.3 score on a scale
Standard Deviation 19.9
|
76.8 score on a scale
Standard Deviation 19.8
|
|
Change From Baseline KOOS Subscale Scores at 12 Months
Sports and Recreation
|
55.1 score on a scale
Standard Deviation 29.1
|
60.7 score on a scale
Standard Deviation 31.2
|
|
Change From Baseline KOOS Subscale Scores at 12 Months
Quality of Life
|
54.2 score on a scale
Standard Deviation 26.6
|
61.5 score on a scale
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: 12 months post-surgeryComparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Change From Baseline Numeric Pain Score at 12 Months
|
2.9 score on a scale (0-10)
Standard Deviation 2.4
|
2.3 score on a scale (0-10)
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 12 months post-surgeryComparison of mean EQ-5D Index score
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Change From Baseline EQ-5D Index Score at 12 Months
|
0.6 Index score
Standard Deviation 0.4
|
0.7 Index score
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 6-weeks post-surgeryPatient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Global Satisfaction Score at 6-Weeks
|
6.9 Score on a scale (0-10)
Standard Deviation 2.5
|
7.7 Score on a scale (0-10)
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 24 months post-surgeryComparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Change From Baseline KOOS Subscale Scores at 24 Months
Sports and Recreation
|
55.9 score on a scale
Standard Deviation 32.2
|
59.1 score on a scale
Standard Deviation 34.5
|
|
Change From Baseline KOOS Subscale Scores at 24 Months
Quality of Life
|
55.9 score on a scale
Standard Deviation 25.6
|
61.7 score on a scale
Standard Deviation 29.3
|
|
Change From Baseline KOOS Subscale Scores at 24 Months
Pain
|
76.6 score on a scale
Standard Deviation 19.9
|
79.2 score on a scale
Standard Deviation 25.1
|
|
Change From Baseline KOOS Subscale Scores at 24 Months
Activities of Daily Living
|
80.4 score on a scale
Standard Deviation 18.9
|
80.3 score on a scale
Standard Deviation 26.9
|
|
Change From Baseline KOOS Subscale Scores at 24 Months
Symptom
|
74.0 score on a scale
Standard Deviation 20.3
|
75.5 score on a scale
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: 24 months post-surgeryComparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Change From Baseline Numeric Pain Score at 24 Months
|
2.5 score on a scale (0-10)
Standard Deviation 2.4
|
2.3 score on a scale (0-10)
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 12 months post-surgeryComparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Change From Baseline EQ-5D Overall Health Score at 12 Months
|
82.5 Points (0-100)
Standard Deviation 16.5
|
87.1 Points (0-100)
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 24 months post-surgeryComparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Change From Baseline EQ-5D Overall Health Score at 24 Months
|
80.9 Points (0-100)
Standard Deviation 17.6
|
88.6 Points (0-100)
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 3 Months post-surgeryPatient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Global Satisfaction Score at 3 Months
|
7.4 Score on a scale (0-10)
Standard Deviation 2.5
|
7.6 Score on a scale (0-10)
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 months post-surgeryPatient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Global Satisfaction Score at 6 Months
|
7.5 Score on a scale (0-10)
Standard Deviation 2.6
|
7.3 Score on a scale (0-10)
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 12 months post-surgeryPatient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Global Satisfaction Score at 12 Months
|
7.6 Score on a scale (0-10)
Standard Deviation 2.7
|
7.8 Score on a scale (0-10)
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 24 months post-surgeryPatient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied.
Outcome measures
| Measure |
Subchondroplasty With Arthroscopy
n=88 Participants
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 Participants
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Global Satisfaction Score at 24 Months
|
7.6 Score on a scale (0-10)
Standard Deviation 3.0
|
8.4 Score on a scale (0-10)
Standard Deviation 2.6
|
Adverse Events
Subchondroplasty With Arthroscopy
Serious events: 13 serious events
Other events: 30 other events
Deaths: 0 deaths
Arthroscopy Alone
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subchondroplasty With Arthroscopy
n=88 participants at risk
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 participants at risk
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Surgical and medical procedures
Total knee replacement (study knee)
|
5.7%
5/88 • Number of events 5 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Displaced MFC fracture
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
Revision amputation, left small finger at middle phalanx
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Total knee arthroplasty (contralateral, non-study knee)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
Right arm fracture requiring ORIF
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Reproductive system and breast disorders
Right breast cancer with surgical intervention and radiation therapy
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Unicompartmental knee arthroplasty (study knee)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Surgical and medical procedures
Right rotator cuff repair, biceps tenodesis
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Surgical and medical procedures
Knee debridement, medial and lateral meniscectomy (contralateral, non-study knee)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
L1 vertebral fracture due to osteoarthritis
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Surgical and medical procedures
Knee arthroscopy, lysis of adhesions, anterior notch adhesions, & manipulation under anesthesia
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Severe back and leg pain
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
Other adverse events
| Measure |
Subchondroplasty With Arthroscopy
n=88 participants at risk
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
|
Arthroscopy Alone
n=43 participants at risk
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
* Partial meniscectomy
* Lavage
* Debridement
* Loose body removal
* Synovectomy
* Removal of osteophytes in the notch or locations other than those adjacent to BML(s)
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increased knee pain (not related)
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Knee Effusion (possibly, probably, or definitely related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
AccuFill Leakage (possibly, probably, or definitely related)
|
2.3%
2/88 • Number of events 2 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
Deep Vein Thrombosis (possibly, probably, or definitely related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
Pulmonary Embolism (possibly, probably, or definitely related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Knee Osteoarthritis (possibly, probably, or definitely related)
|
2.3%
2/88 • Number of events 2 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Increased knee pain (possibly, probably, or definitely related)
|
6.8%
6/88 • Number of events 6 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Stiffness with flexion contracture (possibly, probably, or definitely related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
Extravasation of cement material during implantation (possibly, probably, or definitely related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Cubital and carpal tunnel syndrome
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
General disorders
Increased Pain (non-knee, not related)
|
2.3%
2/88 • Number of events 2 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis (not related)
|
3.4%
3/88 • Number of events 3 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
Fall, accident, or collision
|
3.4%
3/88 • Number of events 3 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Knee effusion (not related)
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Knee Bursitis (not related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff issue
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Lumbago with sciatica
|
0.00%
0/88 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
AccuFill Leakage (not related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Left foot numbness
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Throbbing pain
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
L1 Fracture
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Psoas tendinitis
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Psychiatric disorders
Depression
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Acute midline low back pain with left-sided sciatica
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Surgical and medical procedures
Total knee arthroplasty (not related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Knee swelling (not related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Hip and low back pain (not related)
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spondylosis
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
|
Injury, poisoning and procedural complications
Acute choking while eating
|
1.1%
1/88 • Number of events 1 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
0.00%
0/43 • Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60