Trial Outcomes & Findings for Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears (NCT NCT04361487)
NCT ID: NCT04361487
Last Updated: 2026-02-24
Results Overview
Percentage of participants with freedom from reoperation due to meniscal repair failure at 12 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason.
TERMINATED
33 participants
12 months
2026-02-24
Participant Flow
There were 2 participants enrolled in the study that were excluded from full analysis because the decision was made intraoperatively to not use the study device. These participants were considered screen failures due to intraoperative eligibility criteria and only included in safety adverse event reporting.
Participant milestones
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
Baseline characteristics by cohort
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 10.9 • n=58 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=58 Participants
|
|
Body Mass Index (BMI)
|
27.6 kg/m^2
STANDARD_DEVIATION 4.6 • n=58 Participants
|
|
Tear Type
Horizontal cleavage meniscal tear
|
6 Participants
n=58 Participants
|
|
Tear Type
Complex multi-planar tear
|
25 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
Percentage of participants with freedom from reoperation due to meniscal repair failure at 12 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason.
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=29 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Rate of Freedom From Reoperation at 12 Months After Surgery
|
100 percentage of participants
Interval 88.06 to 100.0
|
SECONDARY outcome
Timeframe: 6 months, 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
Percentage of participants with freedom from reoperation due to meniscal repair failure at 6 months \& 24 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason.
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=30 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Rate of Freedom From Reoperation at 6 & 24 Months After Surgery
6 months
|
100 percentage of participants
Interval 88.43 to 100.0
|
|
Rate of Freedom From Reoperation at 6 & 24 Months After Surgery
24 months
|
100 percentage of participants
Interval 86.28 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
Structural integrity of the meniscus was identified using Magnetic Resonance Imaging (MRI) by the results of the Meniscal Signal Index Meniscus grading. Participants were categorized using the following grading: * Grade 0: Low signal intensity indicative of a normal meniscus. * Grade 1: Irregularly marginated elevated signal with globular shape, suggestive of early meniscal degeneration. * Grade 2: Linear elevated signal (i.e. confirmed fluid signal) not extending into the tibial or femoral articular surface. * Grade 3: Linear elevated signal (i.e. confirmed fluid signal) extending into the tibial or femoral articular surface, suggestive of a tear
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Structural Integrity of Meniscus Assessed by MRI
Baseline · Grade 0
|
0 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
Baseline · Grade 1
|
0 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
Baseline · Grade 2
|
0 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
Baseline · Grade 3
|
31 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
12 months · Grade 0
|
0 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
12 months · Grade 1
|
2 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
12 months · Grade 2
|
0 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
12 months · Grade 3
|
26 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
24 months · Grade 0
|
0 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
24 months · Grade 1
|
1 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
24 months · Grade 2
|
0 Participants
|
|
Structural Integrity of Meniscus Assessed by MRI
24 months · Grade 3
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
Change in Tibiofemoral Joint Space Narrowing (JSN) in the medial compartment was measured in millimeters (mm) as assessed by x-rays.
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=18 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months
|
-0.3 millimeters (mm)
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline to 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
Change in Tibiofemoral Joint Space Narrowing (JSN) in the lateral compartment was measured in millimeters (mm) as assessed by x-rays.
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=18 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months
|
-0.2 millimeters (mm)
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
In-office needle endoscopy is a minimally invasive procedure in which a needle-sized camera is inserted into tissue for observation and/or biopsy purposes. For this study, a needle-sized endoscopy was inserted to record video and images of the meniscal repair site and visually assess healing. Healing by participant was categorized as: * Healed * Incompletely Healed * Failure
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=9 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
In-Office Needle Endoscopy at 6 Months
Healed
|
6 Participants
|
|
In-Office Needle Endoscopy at 6 Months
Incompletely Healed
|
3 Participants
|
|
In-Office Needle Endoscopy at 6 Months
Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
The International Knee Documentation Committee (IKDC) Subjective score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. Possible scores range from 0-100, where 100 indicated the highest level of function and lowest level of symptoms (i.e., better outcome), and 0 indicated the lowest level of function or highest level of symptoms (i.e., worse outcome).
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score
Baseline
|
49.2 score on a scale
Standard Deviation 14.4
|
|
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score
6 months
|
70.2 score on a scale
Standard Deviation 14.5
|
|
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score
12 months
|
76.8 score on a scale
Standard Deviation 15.7
|
|
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score
24 months
|
84.1 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score
Baseline
|
71.3 score on a scale
Standard Deviation 16.0
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score
6 months
|
81.5 score on a scale
Standard Deviation 13.1
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score
12 months
|
85.5 score on a scale
Standard Deviation 14.5
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score
24 months
|
87.5 score on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score
Baseline
|
69.1 score on a scale
Standard Deviation 15.5
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score
6 months
|
83.2 score on a scale
Standard Deviation 11.8
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score
12 months
|
86.6 score on a scale
Standard Deviation 12.5
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score
24 months
|
92.0 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score
Baseline
|
74.9 score on a scale
Standard Deviation 15.5
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score
6 months
|
91.2 score on a scale
Standard Deviation 8.4
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score
12 months
|
92.3 score on a scale
Standard Deviation 11.9
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score
24 months
|
95.2 score on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score
Baseline
|
42.1 score on a scale
Standard Deviation 22.6
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score
6 months
|
68.1 score on a scale
Standard Deviation 19.2
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score
12 months
|
77.7 score on a scale
Standard Deviation 17.5
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score
24 months
|
86.5 score on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used for each subscale with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score
Baseline
|
30.0 score on a scale
Standard Deviation 17.0
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score
6 months
|
57.1 score on a scale
Standard Deviation 22.3
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score
12 months
|
67.7 score on a scale
Standard Deviation 20.5
|
|
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score
24 months
|
75.5 score on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, and 24 monthsPopulation: Full analysis population included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the outcome and time frame specified.
The Lysholm Knee Scoring Scale measures the participant's symptoms and functioning of daily activities by assessing 8 items: limping, using cane or crutches, locking sensation in the knee, giving way sensation from the knee, pain, swelling, climbing stairs, and squatting. The scale is scored on a scale from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning (i.e., a better outcome).
Outcome measures
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=31 Participants
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score
Baseline
|
66.8 score on a scale
Standard Deviation 15.9
|
|
Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score
6 months
|
80.9 score on a scale
Standard Deviation 12.8
|
|
Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score
12 months
|
86.1 score on a scale
Standard Deviation 14.3
|
|
Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score
24 months
|
89.7 score on a scale
Standard Deviation 9.4
|
Adverse Events
NOVOSTITCH™ PRO Meniscal Repair System
Serious adverse events
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=33 participants at risk
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
APNEA
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Reproductive system and breast disorders
MENSTRUAL IRREGULARITIES
|
6.1%
2/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
BONE FRACTURE(S)
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
LIMB FRACTURE
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
General disorders
PAIN
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
Other adverse events
| Measure |
NOVOSTITCH™ PRO Meniscal Repair System
n=33 participants at risk
Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System
NOVOSTITCH™ PRO Meniscal Repair System: Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
|
|---|---|
|
Immune system disorders
HYPERSENSITIVITY/ALLERGIC REACTION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Vascular disorders
UNSPECIFIED VASCULAR PROBLEM
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT INFECTION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
UNSPECIFIED RESPIRATORY PROBLEM
|
6.1%
2/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Eye disorders
CORNEAL ABRASION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Ear and labyrinth disorders
UNSPECIFIED EAR OR LABYRINTH PROBLEM
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Gastrointestinal disorders
GASTRITIS
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Gastrointestinal disorders
UNSPECIFIED GASTROINTESTINAL PROBLEM
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Endocrine disorders
VITAMIN DEFICIENCY
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Reproductive system and breast disorders
BREAST MASS
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Pregnancy, puerperium and perinatal conditions
CONGENITAL DEFECT/DEFORMITY
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
DAMAGE TO LIGAMENT(S)
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
LOSS OF RANGE OF MOTION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
BURNING SENSATION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLORATION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDERS
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Infections and infestations
BACTERIAL INFECTION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Infections and infestations
TOXEMIA
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Infections and infestations
FUNGAL INFECTION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Injury, poisoning and procedural complications
DAMAGE TO LIGAMENT(S)
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
Injury, poisoning and procedural complications
BRUISE/CONTUSION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
General disorders
IMPLANT PAIN
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
General disorders
HEADACHE
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
General disorders
INFLAMMATION
|
3.0%
1/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
General disorders
PAIN
|
27.3%
9/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
|
General disorders
CHEST PAIN
|
6.1%
2/33 • Adverse events were collected during surgery until early termination of the study, up to 2 years.
The Safety population (SAF) was used for adverse event analysis. This included participants enrolled into the study that were implanted with the study device. Additionally, there were 2 participants where implantation of the study device was attempted but was aborted intraoperatively. Adverse events for these 2 participants were included as part of the SAF analysis to ensure any device related adverse events were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 90 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 180 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER