Study of Suture Repair of Torn Meniscus in the Knee

Study Overview
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Brief Summary
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Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the repair, by assessing the re-operation rate, and by assessing improvements in knee pain and knee function.

Detailed Description
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Potential subjects will undergo Screening for eligibility based on Inclusion/Exclusion criteria. Screening will include an x-ray of the injured knee and evaluation of an MRI of the injured knee within 6 months prior to the scheduled procedure. During the procedure, the meniscal tear will be evaluated by arthroscopy to determine if the tear meets study requirements. If the meniscal tear is determined to meet inclusion/exclusion criteria, the subject will be considered enrolled. If any inclusion/exclusion criteria is not met, the subject will be considered a screen failure and will not be enrolled. For enrolled subjects, specific information regarding the repair and repair technique will be collected during the procedure, including still and video images. Subjects will be contacted 7-15 days post-procedure for safety follow-up. Subjects will return for follow-up visits at approximately post-procedure Days 90, 185, 365 and 730. Identical questionnaires will be completed at each visit to assess knee pain and knee function. Safety information will be collected at each post-procedure visit. Additionally, an in-office arthroscopy of the treated knee will be performed at participating sites at Day 185, an MRI of the treated knee will be performed at Day 365 and an X-ray of the treated knee will be performed at Day 730. The patient will exit the study at the Day 730 visit.

Official Title
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A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)

Conditions
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Meniscal Tear, Meniscus Tear

Intervention / Treatment
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* Device: Suture-based meniscal repair


Participation Criteria
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Eligibility Criteria
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Screening Inclusion Criteria: Subjects of either gender may be eligible for inclusion in the study only if they meet all of the following criteria: Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board 18 to 60 years of age, inclusive at the time of screening; History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way); Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression); If prior ligament reconstruction, the study knee is clinically stable; Preoperative MRI evidence within 6 months consistent with a horizontal/radial/oblique meniscus tear in the symptomatic compartment Arthroscopy Inclusion Criteria: Consented subjects may be included in the study only if, upon arthroscopic inspection, their meniscal study lesion meets all of the following criteria established by the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) (see Appendix 1): Zone location: circumferential location of tear includes locations within 10mm of the peripheral rim of the meniscus; Radial location: any location from anterior to posterior; Tear pattern: primarily horizontal or oblique in orientation (not to exceed 45 degrees from horizontal); Compartment: either lateral or medial, but not both; Opposite compartment meniscal tear (if present) limited to the central portion (i.e., Zone 3/white zone); Tear amenable to repair with all suture-based techniques. Screening Exclusion Criteria: Subjects will be excluded from the study for any of the following reasons: Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher [See Appendix 4]); Body Mass Index (BMI) ≥35 kg/m2; Previous meniscal repair or meniscectomy of the study meniscus; Unstable knee; Malalignment (> 5 degrees) of the study knee, based on X-ray within 6 months requiring osteotomy and/or requiring correction; History of constitutional/systemic inflammatory/arthritic problem or pain condition, history of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, HIV, drug/alcohol abuse, tobacco use, cancer; Expected to undergo any other primary treatment of the knee; Any concomitant painful or disabling disease, condition or post-procedure status of either lower extremity that would interfere with evaluation or rehabilitation of the study knee. Pregnant or planning to become pregnant in the next 2 years. Arthroscopy Exclusion Criteria: Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy: Tear pattern: primarily vertical longitudinal in orientation; Partial meniscectomy of any portion of the study meniscus extends beyond the central portion (i.e., Zone 3/white zone); Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair; Poor meniscal tissue quality such that it will not hold a suture; Any portion of the meniscus repair that, in the opinion of the Investigator, is best treated using an implant other than suture; Bicompartmental Zone 1/red zone and/or Zone 2/red-white zone meniscal tears; Performance of a significant concomitant procedure intended as a therapeutic intervention on the study knee; Arthritis in the surgical knee (International Cartilage Research Society [ICRS] Grade 3b or higher or Modified Outerbridge Grade III or higher)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Suture-based meniscal repair | Device: Suture-based meniscal repair<br>* Suture-based meniscal repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation) | Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure. | 6 months, 1 year, and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion of The International Knee Documentation Committee (IKDC) Subjective score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. | Baseline, 3 months, 6 months, 1 year, and 2 years | 
| Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have 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 and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately. | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have 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 and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately. | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have 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 and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately. | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have 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 and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately. | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have 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 and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately. | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion of the Lysholm Knee Questionnaire. This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning. | Baseline, 3 months, 6 months, 1 year, and 2 years | 
| Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years | Change in knee pain and function will be measured by completion of the Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports. | Baseline, 3 months, 6 months, 1 year, and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meniscal, meniscus, repair, knee, arthroscopy knee, horizontal