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| Name | Class |
|---|---|
| DJO Incorporated | INDUSTRY |
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The purpose of this study is to evaluate the use and efficacy of the ReverseĀ® 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 ReverseĀ® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSP Device | Post Market Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encore Reverse Shoulder Prosthesis (RSPĀ®) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic Success | Changes in radiolucency compared with Baseline | 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. |
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Inclusion Criteria:
Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; Failed shoulder replacement surgery
Exclusion Criteria:
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Subjects who are 60 years of age or older at the time of consent and are suffering from a grossly rotator cuff deficient shoulder joints with severe arthropathy or have a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
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| Name | Affiliation | Role |
|---|---|---|
| Samer S. Hasan, M.D. | Cincinnati Sports Medicine and Orthopaedic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University - Dept. of Orthopedics | Redwood City | California | 94063 | United States | ||
| Coastal Orthopedics & Sports Medicine |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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|
| 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 | 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 | 5 year |
| Subject Satisfaction Survey | Patient Related Outcome of Device Satisfaction (score 1-5 with 1 = best and 5 = worst) Device satisfaction | 5 year |
| Bradenton |
| Florida |
| 34209 |
| United States |
| Orthopaedic Institute at Holy Cross Hospital | Fort Lauderdale | Florida | 33334 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Norton Orthopaedic & Sports Medicine Specialists | Louisville | Kentucky | 40241 | United States |
| Excelsior Orthopaedics | Amherst | New York | 14226 | United States |
| Cincinnati Sports Medicine and Orthopeadic Center | Cincinnati | Ohio | 45242 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Texas Center for Joint Replacement | Plano | Texas | 75093 | United States |
| Rimrock Orthopedics | St. George | Utah | 84790 | United States |