NCT03097744

Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-04-20
• Completion: 2018-04-20
• First posted: 2017-03-31
• Last updated: 2020-09-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study