Rotator Cuff Failure With Continuity (NCT02716441)
Failure With Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes
🩺 Plain-English Summary (8th-Grade Level)
This proposal's objective is to challenge and expand the current definition of rotator cuff healing by investigating tendon retraction - broadly defined as medial translation of the repaired tendon away from the bone with or without a defect - as a common and clinically predictive structural outcome following rotator cuff repair. The investigators' central hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon of rotator cuff healing that is significantly and meaningfully correlated with clinical outcomes. The investigators' approach is to characterize tendon retraction using an array of implanted radio-opaque markers, and investigate its relationship to pre-operative tissue quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a 125-patient prospective cohort study. These patients will complete (1) validated questionnaires and range of motion testing pre-operatively, (2) CT imaging at day of surgery, 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively, (3) MRI at 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively and (4) questionnaires, range of motion and strength testing at 3 and 6 months and 1, 2 and 5 years post-operatively.
Who can join: Review the eligibility criteria below.
Location: Cleveland Clinic Main Campus — Cleveland, Ohio
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic Main Campus — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (866) 223-8100
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rotator Cuff Tear
- Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears — Phoenix, Arizona
- Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears — New York, New York
- FiberLocker® System Augmentation of Rotator Cuff Repairs — Chicago, Illinois
- Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation — New York, New York
- Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears — Toronto, Ontario
Explore by condition: All Rotator Cuff Tear clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.