About this trial
This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.
Eligibility criteria
Qualifiers
Adults with massive rotator cuff tear
Tear must affect at least two tendons
Primary surgery only
Origin of tear can be either degenerative or traumatic
Disqualifiers
Fatty infiltration grade 4 (according to Goutallier)
Bilateral tears
Cases of arthritis or severe osteoarthritis
Structural or pathological condition of the bone or soft tissue that could impair healing
Trial design
Treatments tested in this trial
- Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))
- Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch