About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant women, non-English speakers and prisoners.
Patients with prior surgery on the ipsilateral shoulder.
Worker's compensation status.
Adhesive capsulitis.
Trial design
Parallel
Treatments tested in this trial
Rotator cuff repair with biceps patch augmentation
Procedure/SurgeryThis 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
Procedure/SurgeryStandard of care technique. Active comparator
Treatment groups
Trial outcomes
Primary outcomes
ASES Score
American Shoulder and Elbow Surgeons Score. From 0-100. Higher is better
Secondary outcomes
Rotator cuff healing
Signs of cuff healing in MRI
Other outcomes
SANE Score
From 0-100, how good the shoulder feels. Higher is better
VAS Pain Score
0-10. Higher is worse
ROM
Range of motion
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Joseph W. Galvin
Lead sponsor
University of Iowa
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: