Knee Medial Meniscus Tears, Meniscus Disorder, Meniscus Lesion, Meniscus; Rupture, Bucket Handle
Conditions
Keywords
Lateral Meniscus Tear, Medial Meniscus Tear
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.
Interventions
DEVICECeterix 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.
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rate | January 2015-February 2016 | Data provided by patients |
| Validated patient-reported outcomes measures | January 2015-February 2016 | IKDC Subjective |
| 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 |
Countries
United States
Outcome results
None listed