Adults 18 to 70, any sex, with Meniscus Tear or Retention; Meniscus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Freedom From Reoperation at 12 Months After SurgeryPrimary· 12 months
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.
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
100
88.06 – 100
Rate of Freedom From Reoperation at 6 & 24 Months After SurgerySecondary· 6 months, 24 months
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.
6 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
100
88.43 – 100
24 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
100
86.28 – 100
Structural Integrity of Meniscus Assessed by MRISecondary· Baseline, 12 months, and 24 months
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 t
Baseline
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
0
NOVOSTITCH™ PRO Meniscal Repair System
0
NOVOSTITCH™ PRO Meniscal Repair System
0
NOVOSTITCH™ PRO Meniscal Repair System
31
12 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
0
NOVOSTITCH™ PRO Meniscal Repair System
2
NOVOSTITCH™ PRO Meniscal Repair System
0
NOVOSTITCH™ PRO Meniscal Repair System
26
24 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
0
NOVOSTITCH™ PRO Meniscal Repair System
1
NOVOSTITCH™ PRO Meniscal Repair System
0
NOVOSTITCH™ PRO Meniscal Repair System
24
Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 MonthsSecondary· Baseline to 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in the medial compartment was measured in millimeters (mm) as assessed by x-rays.
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
-0.3
± 0.8
Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 MonthsSecondary· Baseline to 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in the lateral compartment was measured in millimeters (mm) as assessed by x-rays.
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
-0.2
± 0.7
In-Office Needle Endoscopy at 6 MonthsSecondary· 6 months
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
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
6
NOVOSTITCH™ PRO Meniscal Repair System
3
NOVOSTITCH™ PRO Meniscal Repair System
0
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective ScoreSecondary· Baseline, 6 months, 12 months, and 24 months
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).
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
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
Baseline
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
69.1
± 15.5
6 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
83.2
± 11.8
12 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
86.6
± 12.5
24 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
92.0
± 9.0
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life ScoreSecondary· Baseline, 6 months, 12 months, and 24 months
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
Baseline
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
74.9
± 15.5
6 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
91.2
± 8.4
12 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
92.3
± 11.9
24 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
95.2
± 7.2
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport ScoreSecondary· Baseline, 6 months, 12 months, and 24 months
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
Baseline
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
42.1
± 22.6
6 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
68.1
± 19.2
12 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
77.7
± 17.5
24 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
86.5
± 14.6
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life ScoreSecondary· Baseline, 6 months, 12 months, and 24 months
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
Baseline
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
30.0
± 17.0
6 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
57.1
± 22.3
12 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
67.7
± 20.5
24 months
Group
Value
95% CI
NOVOSTITCH™ PRO Meniscal Repair System
75.5
± 17.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected during surgery until early termination of the study, up to 2 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
Last refreshed: 24 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04361487.