Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs (STITCHRetro)

Smith & Nephew

Status: Completed

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

Treatments: Device: Ceterix NovoStitch

Study type: Observational

Funder types: Industry

Identifiers

NCT03097744

CTX-CP003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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