Clinical Research Directory
Browse clinical research sites, groups, and studies.
Arthroscopic Rotator Cuff Repair Trial
Sponsor: Joseph W. Galvin
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.
Official title: A Prospective Randomized Controlled Trial Comparing Arthroscopic Rotator Cuff Repair With and Without Biceps Tendon Autograft Patch Augmentation
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-06-01
Completion Date
2027-09-30
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
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
Rotator cuff repair without biceps patch augmentation
Standard of care technique. Active comparator