Stopped: withdrawn
The purpose is to assess Rotium, a novel nanoscaffold, impact on healing of a repaired rotator cuff and compare to a repair without Rotium. Animal (sheep) models have shown both quicker and more organized healing when Rotium is used, but there are no studies to confirm these outcomes translate to human population. Hypothesis: Rotium rotator cuff repairs will heal both quicker and better than traditional rotator cuff repair techniques.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Rotator cuff integrity baseline/preoperative
Timeframe: preoperative
Rotator cuff repair integrity @ 2 weeks
Timeframe: postoperative at 2 weeks
Rotator cuff repair integrity @ 4 weeks
Timeframe: postoperative at 4 weeks
Rotator cuff repair integrity @ 6 weeks
Timeframe: postoperative at 6 weeks
Rotator cuff repair integrity @ 3 months
Timeframe: postoperative 3 months
Rotator cuff repair integrity @ 6 months
Timeframe: postoperative at 6 months
Rotator cuff repair integrity @ 12 months
Timeframe: postoperative at 12 months
Postoperative rotator cuff vascularity during healing
Timeframe: postoperative at 2 weeks
Postoperative rotator cuff vascularity during healing
Timeframe: postoperative at 4 weeks
Postoperative rotator cuff vascularity during healing
Timeframe: postoperative at 6 weeks
Postoperative rotator cuff vascularity during healing
Timeframe: postoperative at 3 months
Postoperative rotator cuff vascularity during healing
Timeframe: postoperative at 6 months
Postoperative rotator cuff vascularity during healing
Timeframe: postoperative at 12 months