Encore Medical, L.P.
The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.
Reverse shoulder arthroplasty (RSA) is performed to provide improvement in pain relief and restoration of function in patients with rotator cuff tear arthropathy and massive irreparable rotator cuff tears . Traditional total shoulder designs failed to address the unique mechanics of shoulders with deficient rotator cuffs. Different prosthesis designs exist for RSA, all of which increase the deltoid lever arm to provide a stable fulcrum for active elevation in a rotator cuff deficient shoulder. The Reverse® Shoulder Prosthesis (RSP®) (DJO Surgical) sought to address issues correlated to the Gr…
Inclusion Criteria: 1. Subject is ≥21 years of age 2. Subject is scheduled for reverse shoulder arthroplasty with the AltiVate Reverse device due to primary diagnosis of severe arthropathy with a grossly deficient rotator cuff 3. Subject's sub scapularis has been determined from MRI to be sufficient to repair 4. Subject is willing and able to comply with the study schedule and assessments 5. Subject is likely to be available for evaluation for the duration of the study 6. Subject is willing and able to sign the informed consent Exclusion Criteria: 1. Subject is indicated for reverse shoulde…
Utilizing fiberwire, high tensile strength suture
Reverse shoulder arthroplasty device