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S&P of Q-Fix™ All-Suture Anchor System

NCT03594071 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 294

Last updated 2021-02-09

Study results available
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Summary

Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements

Conditions

  • Bankart Lesion
  • Acetabular Labrum Tear
  • SLAP Lesion
  • Acromioclavicular Sprain
  • Capsular Shift/Capsulolabral Reconstruction
  • Deltoid Repair
  • Rotator Cuff Repair
  • Bicep Tendinitis
  • Extra-capsular Repair
  • Medial Collateral Ligament
  • Lateal Collateral Ligament
  • Posterior Oblique Ligament
  • IBT
  • Vastus Medialis
  • Obliquus Advancement
  • Joint Capsule Closure

Interventions

DEVICE

The Q-Fix™ All-Suture Anchor

Observational, post-market, clinical follow-up study

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Langone · GBR - T. J. Smith and Nephew Limited

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2019-12-11
Completion
2019-12-11
FDA Device
Yes

Countries

  • United States

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 NCT03594071 on ClinicalTrials.gov