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Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations

NCT04903106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2026-03-18

Study results available
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Summary

This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.

Conditions

  • Meniscus Tear

Interventions

DEVICE

FAST-FIX FLEX Meniscal Repair System

Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.

DEVICE

FAST-FIX FLEX Meniscal Repair System

Standard of care surgery in which the FASTFIX FLEX device is used during the meniscal allograft transplantation procedure.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2024-11-26
Completion
2024-11-26
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • United Kingdom

Study Locations

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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 NCT04903106 on ClinicalTrials.gov