Arthroscopic Rotator Cuff Repair Trial

Starting soon · Not applicable

Conditions studied: Rotator Cuff Tears

In brief

This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft patch augmentation. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active shoulder range of motion, and healing signs on MRI imaging studies at minimum 6-months postoperatively.

Key facts

Study ID

NCT07568392

Run by

Joseph W. Galvin

People needed

80

Starts

2026-06-01

Expected to finish

2027-09-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients > 18 years of age who speak English, indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis.
• Supraspinatus (+/- anterior infraspinatus tendon) full thickness tears.
• Medium (1-3cm) and large (3-5) cm tears. Classification according to anterior to posterior dimensions: small <1cm, medium 1-3 cm, large 3-5 cm, massive >5cm or 2 tendons.
• Patte Grade 1 and 2. Patte Classification: grade 1, tear at insertion; grade 2, retracted to humeral head; grade 3, retracted to glenoid or medial to glenoid.
• Goutallier grade 0-2 fatty infiltration on pre-operative MRI.
• Repairable upper border subscapularis tendon tear.
• Patients undergoing concomitant biceps tenodesis.

You may not qualify if…

• Pregnant women, non-English speakers and prisoners.
• Patients with prior surgery on the ipsilateral shoulder.
• Worker's compensation status.
• Adhesive capsulitis.
• Patient with glenohumeral osteoarthritis, as graded by the modified Samilson and Prieto Classification (grades 1-3).
• Partial thickness rotator cuff tears.
• Any cuff tears requiring medialization of the footprint
• Patients undergoing concomitant distal clavicle resection.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.