Biomarkers to Predict Rotator Cuff Repair Healing on Postoperative MRI

NCT07781553 | Recruiting

• 1 other identifier: 202406235
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tears

Keywords

rotator cuff tear; rotator cuff healing

Outcome Measures

Primary Outcomes (1)

• Rotator cuff healing

  Rotator cuff healing postoperatively, as assessed on MRI

  6 months to 1 year post-operative

Study Arms (1)

Rotator cuff repair

OTHER

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

Diagnostic Test: MRN

Interventions

MRN DIAGNOSTIC_TEST

MRN without contrast

Rotator cuff repair

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Joseph W. Galvin: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Joseph Galvin, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Galvin, Other, MD

CONTACT

3193848378; joseph-galvin@uiowa.edu

Maria F Bozoghlian, MD

CONTACT

3196785003; maria-bozoghlian@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)