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

Completed

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT03594071

Run by

Smith & Nephew, Inc.

People needed

294

Starts

2018-08-31

Expected to finish

2019-12-11

Last updated by the study team

2021-02-09

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System
• Subject was ≥ 13 of age at time of surgery

You may not qualify if…

• Subject is ≤ 6 months post-operative
• Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Where it is running

• The Orthopaedic Center- Center for Advanced Orthopaedics — Washington D.C., District of Columbia, United States
• Northshore University Health System — Chicago, Illinois, United States
• Tulane University Medical Center /Tulane Institute of Sport Medicine — New Orleans, Louisiana, United States
• Oklahoma Sports and Orthopedics Institute — Oklahoma City, Oklahoma, United States
• Palmetto Health USC Orthopedic Center — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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