Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

Completed

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

• Registration Number: NCT03097744
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Status Verified: 2019-01
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reoperation Rate	January 2015-February 2016	Data provided by patients
Contribution of the following retrospective covariates on failure and outcomes when available	January 2015-February 2016	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
Validated patient-reported outcomes measures	January 2015-February 2016	IKDC Subjective

Trial Locations

Locations (1)

Agility Center Orthopedics; 🇺🇸 Bentonville, Arkansas, United States