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
Qualifiers
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
Treatments tested in this trial
- Rotator cuff repair with biceps patch augmentation
- Rotator cuff repair without biceps patch augmentation
Treatment groups
Locations
Sponsors and collaborators
Joseph W. Galvin
Lead sponsor
University of Iowa
Sponsor institution