InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear

Main Inclusion Criteria: * Age 40 or older. * Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon. * Persistent pain and functional disability of the affected shoulder for at least 3 months. Main Exclusion Criteria : * Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone). * Evidence of significant osteoarthritis or cartilage damage in the shoulder * Evidence of gleno-humeral instability * Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy * Evidence of major joint trauma, infection, or necrosis in the shoulder * Partial-thickness tears of the rotator cuff