Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

NCT ID: NCT03097744

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-04-20

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn Olson

Role: STUDY_DIRECTOR

Ceterix Orthopaedics

Locations

Agility Center Orthopedics

Bentonville, Arkansas, United States

Countries

United States

References

Saliman JD. The circumferential compression stitch for meniscus repair. Arthrosc Tech. 2013 Jul 12;2(3):e257-64. doi: 10.1016/j.eats.2013.02.016. eCollection 2013.

Reference Type: BACKGROUND

PMID: 24265995 (View on PubMed)

Nepple JJ, Dunn WR, Wright RW. Meniscal repair outcomes at greater than five years: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012 Dec 19;94(24):2222-7. doi: 10.2106/JBJS.K.01584.

Reference Type: BACKGROUND

PMID: 23318612 (View on PubMed)

Other Identifiers

CTX-CP003

Identifier Type: -

Identifier Source: org_study_id