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NCT07781553
Biomarkers to Predict Rotator Cuff Repair Healing on Postoperative MRI
Conditions: Rotator Cuff Tears
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Joseph W. Galvin
Location: University of Iowa Iowa City Iowa
Summary
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.
Eligibility Criteria
Inclusion Criteria:
age 18-99 years partial or full thickness posterior superior rotator cuff tear that underwent surgical repair and are consented in the Orthopedics Biobank under IRB# 202403832.
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.
Source: ClinicalTrials.gov (NCT07781553). StuddyBuddy aggregates publicly available trial information.