Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

Study Overview
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Brief Summary
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This is a retrospective study of meniscal tear repairs at least one-year post repair status. All patients were treated with Ceterix NovoStitch devices. The primary objectives of this study are to assess the clinical repair success rate via reoperation and PROs at greater than 12 months.

Detailed Description
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The study is a retrospective, non-randomized, single-group assignment, open-label study of repairs of meniscal tears status post repair. The following clinical efficacy endpoints will be evaluated at greater than 12 months: Reoperation rate Validated patient-reported outcomes measures Contribution of the following retrospective covariates on failure and outcomes when available: Type of tear, Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction.

Official Title
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Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

Conditions
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Knee Medial Meniscus Tears, Meniscus Lesion, Meniscus; Rupture, Bucket Handle, Meniscus Disorder

Intervention / Treatment
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* Device: Ceterix NovoStitch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to give consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable) In the opinion of the Investigator are able to comply with study-required follow-up Exclusion Criteria: Post-operative interval <1year Concurrent bony fractures Post-operative reinjury (except the meniscus) Pre-operative arthritis grade 3 or higher on modified outerbridge Knee surgery prior to meniscus repair surgery Any kind of infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ceterix NovoStitch|The device allows the physician to place a circumferential compression stitch around meniscal tears. This stitch is placed by passing suture from the tibial side to the femoral side of the meniscus and across the tear. This allows compression across the entire tear surface.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation Rate | Data provided by patients | January 2015-February 2016 | 
| Validated patient-reported outcomes measures | IKDC Subjective | January 2015-February 2016 | 
| Contribution of the following retrospective covariates on failure and outcomes when available | Type of tear Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction | January 2015-February 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Meniscus Tear, Medial Meniscus Tear