Post-Market Evaluation of the Rotation Medical Rotator Cuff System (NCT02200939) | Clinical Trial Compass
CompletedNot Applicable
Post-Market Evaluation of the Rotation Medical Rotator Cuff System
United States148 participantsStarted 2014-08-20
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 21 years of age
✓. Rotator cuff tear requiring surgery that meets either criterion A or B:
✓. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
✓. MRI of the shoulder within 60 days prior to the study procedure
✓. Willing to comply with the prescribed post-operative rehabilitation program
✓. Willing to be available for each protocol-required follow-up examination
✓. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
✓. Ability to read, understand, and complete subject-reported outcomes in English
Exclusion criteria
✕. Massive rotator cuff tears (≥ 5 cm)
✕. Acute rotator cuff tears less than 12 months from injury
✕. Previous rotator cuff surgery on the index shoulder
✕. Instability of the index shoulder
✕. Chondromalacia of index shoulder ≥ Grade 3
What they're measuring
1
Change in Tendon Thickness
Timeframe: Pre-operatively (baseline) to 3 month, 1 year, and 2 year
2
Integration of Induced Tissue With Underlying Tendon
Timeframe: 3 months, 1 year, and 2 years
3
Fill-In of Partial Thickness Tears and Underlying Tendon Quality