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SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures

NCT05491564 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-02-02

No results posted yet for this study

Summary

Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single cohort, longitudinal study is intended to evaluate the effectiveness and safety profile of SoftStitch™ when used as standard of care for All-Inside Meniscal Repair. Electronic Patient Reported Outcome Measures (ePROM), functional assessments of the knee, Adverse Events of interest and Adverse Device Effects will be assessed.

Conditions

  • Meniscus Tear

Interventions

DEVICE

SoftStitch™

The SoftStitch™ meniscal repair system includes a unique knotless all-inside meniscal repair implant with all suture fixation, eliminating the traditional hard plastic PEEK anchors used in the previous devices.

Sponsors & Collaborators

  • Arthrex, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-10-01
Completion
2024-10-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491564 on ClinicalTrials.gov