Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

Smith & Nephew, Inc.23 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Ceterix NovoStitchDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Agility Center Orthopedics

Bentonville, Arkansas, United States

Outcomes

Primary Outcomes

Reoperation Rate

Data provided by patients

Time frame: January 2015-February 2016

Validated patient-reported outcomes measures

IKDC Subjective

Time frame: 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

Time frame: January 2015-February 2016

Data from ClinicalTrials.gov

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