Arthroscopic Rotator Cuff Repair Trial

A Prospective Randomized Controlled Trial Comparing Arthroscopic Rotator Cuff Repair With and Without Biceps Tendon Autograft Patch Augmentation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Rotator cuff repair without biceps patch augmentation; Procedure: Rotator cuff repair with biceps patch augmentation

Detailed Description

Rotator cuff tears are common causes of shoulder pain, and it is a highly prevalent condition among a variety of ages. Treatment options for rotator cuff tears include nonsurgical and surgical options. Surgical repair of rotator cuff tears is a widely accepted treatment option; however, re-tear rates are concerning and a frequent complication. Published studies suggest failure rates ranging from 11-94%. Different surgical techniques have been designed to address this potential complication, such as patch augmentation. Recently, patch augmentation with biceps tendon autograft has been utilized as a cost-effective approach. Therefore, the purpose of this study is to evaluate and compare post-operative outcomes and tendon healing rates after rotator cuff repairs with and without patch augmentation with biceps tendon. 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. Both surgical techniques are standard of care procedures performed routinely at University of Iowa Health Care. 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. 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 range of motion, and healing signs on imaging studies at minimum 6-months postoperatively. Participants in both arms will undergo a shoulder MRI without contrast at 6 months post-operatively. This MRI is the same type of MRI perform as diagnosis or control as standard of care practices.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Galvin, Other, MD; Phone Number: 3193848378; Email: joseph-galvin@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cuff repair without patch autograft; Arthroscopic rotator cuff repair without patch augmentation	Procedure: Rotator cuff repair without biceps patch augmentation; Standard of care technique. Active comparator
Experimental: Cuff repair with patch augmentation; Arthroscopic rotator cuff repair with patch augmentation	Procedure: Rotator cuff repair with biceps patch augmentation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES Score	American Shoulder and Elbow Surgeons Score. From 0-100. Higher is better	1 year post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotator cuff healing	Signs of cuff healing in MRI	6 months post-operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SANE Score	From 0-100, how good the shoulder feels. Higher is better	1 year post-operative
VAS Pain Score	0-10. Higher is worse	1 year post-operative
ROM	Range of motion	1 year post-operative

Collaborators and Investigators

• Sponsor: Joseph W. Galvin

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 202512509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No