Biomarkers to Predict Rotator Cuff Repair Healing on Postoperative MRI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorJoseph W. Galvin

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • MRN

    Diagnostic test

    MRN without contrast

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Rotator cuff repairOther 1 intervention

Trial outcomes

Primary outcomes

1

Rotator cuff healing

Rotator cuff healing postoperatively, as assessed on MRI

Time frame
6 months to 1 year post-operative

Secondary outcomes

Other outcomes

Sponsors and contacts

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Joseph W. Galvin

Lead sponsor

University of Iowa

Sponsor institution