Biomarkers to Predict Rotator Cuff Repair Healing on Postoperative MRI

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Joseph W. Galvin
Study ID
NCT07781553
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MRN — DIAGNOSTIC_TEST
    MRN without contrast

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jul 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Rotator cuff repair
    All participants of the Orthopedics Biobank who underwent a rotator cuff repair will be part of arm 1

Primary Outcome Measure

Rotator cuff healing [ Time Frame: 6 months to 1 year post-operative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Joseph Galvin, DO
[email protected]
3193537091
Maria F Bozoghlian, MD
[email protected]
3196785003

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By research site
University of Iowa· Iowa City, IA

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