Biomarkers to Predict Rotator Cuff Repair Healing on Postoperative MRI (NCT07781553)
🩺 Plain-English Summary (8th-Grade Level)
Rotator cuff repair healing is highly variable with healing failure rates ranging from 11 to 94%. To this date, there are no specific biomarkers in shoulder tissues that can be associated with rotator cuff healing after surgery. The purpose of this study is to perform diagnostic imaging study (MRI without contrast), for research purposes, to subjects in the Orthopedics Biobank (IRB#202403832), to identify biomarkers associated with failure of rotator cuff repair healing. We will evaluate biomarkers in synovial fluid and shoulder tissues collected and analyzed as part of the IRB#202403832, and correlate the difference in biomarkers in patients that did and did not have signs of healing in the MRI. Secondarily, we aim to develop a model using demographics, radiographic parameters/MRI measurements and biomarkers to accurately predict rotator cuff repair healing rates at 1-year following surgery. This will be a study from a population of patients who are enrolled in the Orthopedic biorepository under IRB #202403832. Patients who underwent a rotator cuff repair will be invited to get an MRI without contrast of their operated shoulder at a period between 6 months to 1 year post-operative.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (1 items).
Location: University of Iowa — Iowa City, Iowa
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria prisoners pregnant patients patients with prior shoulder surgery on the ipsilateral side adhesive capsulitis patients undergoing concomitant distal clavicle resection worker's compensation patients with postoperative complications.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Iowa — Iowa City, Iowa
💰 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.