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

Smith & Nephew

Status: Completed

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

Treatments: Device: The Q-Fix™ All-Suture Anchor

Study type: Observational

Funder types: Industry

Identifiers

NCT03594071

17-5010-11

Details and patient eligibility

About

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

Enrollment: 294 patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design