Trials / Completed
CompletedNCT02200939
Post-Market Evaluation of the Rotation Medical Rotator Cuff System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bioinductive implant | |
| DEVICE | Surgical repair | Surgical repair with commercially-available sutures/suture anchors. |
Timeline
- Start date
- 2014-08-20
- Primary completion
- 2020-11-24
- Completion
- 2020-11-24
- First posted
- 2014-07-25
- Last updated
- 2022-03-02
- Results posted
- 2022-03-02
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02200939. Inclusion in this directory is not an endorsement.