S&P of Q-Fix™ All-Suture Anchor System
Purpose
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
Eligibility
- Eligible Ages
- Over 13 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Retrospective
More Details
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.