Trials / Completed
CompletedNCT03594071
S&P of Q-Fix™ All-Suture Anchor System
Safety and Performance of Q-Fix™ All-Suture Anchor System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 294 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | The Q-Fix™ All-Suture Anchor | Observational, post-market, clinical follow-up study |
Timeline
- Start date
- 2018-08-31
- Primary completion
- 2019-12-11
- Completion
- 2019-12-11
- First posted
- 2018-07-20
- Last updated
- 2021-02-09
- Results posted
- 2021-02-09
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03594071. Inclusion in this directory is not an endorsement.