Recruiting

Biomarkers in Rotator Cuff

Sponsor:

Joseph W. Galvin

Code:

NCT07781553

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MRN

Study Details

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

Study ID

NCT07781553

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Rotator cuff repair

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

Interventions

MRN

MRN without contrast

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Joseph W. Galvin

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • rotator cuff tear; rotator cuff healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joseph W. Galvin on 2026-08-24.