The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).
Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.
Study Type
OBSERVATIONAL
Enrollment
245
The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
Stanford University - Dept. of Orthopedics
Redwood City, California, United States
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States
Orthopaedic Institute at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
Time frame: 2 year
Radiologic Success
Changes in radiolucency compared with Baseline
Time frame: 5 year
Change in ASES score from Baseline
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
Time frame: 5 year
SF36- (Short Form 36)Health Survey
Change from baseline using the SF36-Health Status. There are multiple scales for general health, pain and activities of daily living
Time frame: 5 year
Change in Simple Shoulder Test from Baseline
Change in Simple Shoulder Test from Baseline. Twelve questions about pain and functionality with responses being yes or no
Time frame: 5 year
Subject Satisfaction Survey
Patient Related Outcome of Device Satisfaction (score 1-5 with 1 = best and 5 = worst) Device satisfaction
Time frame: 5 year
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Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Norton Orthopaedic & Sports Medicine Specialists
Louisville, Kentucky, United States
Excelsior Orthopaedics
Amherst, New York, United States
Cincinnati Sports Medicine and Orthopeadic Center
Cincinnati, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Texas Center for Joint Replacement
Plano, Texas, United States
Rimrock Orthopedics
St. George, Utah, United States