Arthroscopic Rotator Cuff Repair Trial

NCT07568392 | Not Yet Recruiting DMC

• 1 other identifier: 202512509
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• ASES Score

  American Shoulder and Elbow Surgeons Score. From 0-100. Higher is better

  1 year post-operative

Secondary Outcomes (1)

• Rotator cuff healing

  6 months post-operative

Other Outcomes (3)

• SANE Score

  1 year post-operative

• VAS Pain Score

  1 year post-operative

• ROM

  1 year post-operative

Study Arms (2)

Cuff repair without patch autograft

ACTIVE COMPARATOR

Arthroscopic rotator cuff repair without patch augmentation

Procedure: Rotator cuff repair without biceps patch augmentation

Cuff repair with patch augmentation

EXPERIMENTAL

Arthroscopic rotator cuff repair with patch augmentation

Procedure: Rotator cuff repair with biceps patch augmentation

Interventions

Rotator cuff repair with biceps patch augmentation PROCEDURE

This is a standard of care practice surgical technique. This arm will undergo arthroscopic rotator cuff repair with the use of called "Biceps Smash" technique which may provide improved tendon thickness and biology with limited morbidity and in a cost effective approach

Cuff repair with patch augmentation

Rotator cuff repair without biceps patch augmentation PROCEDURE

Standard of care technique. Active comparator

Cuff repair without patch autograft

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Joseph W. Galvin: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Joseph Galvin, Other, MD

CONTACT

3193848378; joseph-galvin@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and research staff who collect outcomes will be blinded to arm randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04