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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03097744
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Completed
Phase
Start date February 1, 2017
Completion date April 20, 2018

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