RSP® Prospective Multi-Center Study
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Rotator Cuff Deficiency Shoulder Arthropathy Failed Shoulder Replacement |
Device: Encore Reverse Shoulder Prosthesis (RSP®) |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis |
- Improvement in American Shoulder and Elbow Surgeons (ASES) Score from Baseline [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Radiologic Success [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- Change in ASES score from Baseline [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- Change in SF36-Health Status from Baseline [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- Change in Simple Shoulder Test from Baseline [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- Subject Satisfaction Survey [ Time Frame: 5 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 224 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
RSP Device
Post Market Study
|
Device: Encore Reverse Shoulder Prosthesis (RSP®)
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.
Other Name: RSP®
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Subject must be a candidate for a total shoulder joint replacement
- Subject must be diagnosed with one or more of the following conditions:
Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; Failed shoulder replacement surgery
- Subject has a functional deltoid muscle
- Subject's joint must be anatomically and functionally suited to receive the selected implant
- Subject is 60 years of age or older (≥ 60 yrs of age) at time of consent
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
- Subject is not pregnant
Exclusion Criteria:
- Subject has a non-functional deltoid muscle
- Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
- Subject has high levels of physical activity (ex. competitive sports, heavy physical labor)
- Subject is pregnant
- Subject has an active infection or sepsis
- Subject has loss of ligamentous structures
- Subject has a history of alcoholism or other addictions (current or past)
- Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
- Subject has severe glenoid bone loss
- Subject has known materials sensitivity (to metals)
- Subject is younger than 60 years of age (< 60 years of age) at consent
Contacts and Locations| United States, California | |
| Stanford University - Dept. of Orthopedics | |
| Redwood City, California, United States, 94063 | |
| United States, Florida | |
| Coastal Orthopedics & Sports Medicine | |
| Bradenton, Florida, United States, 34209 | |
| Orthopaedic Institute at Holy Cross Hospital | |
| Fort Lauderdale, Florida, United States, 33334 | |
| United States, Illinois | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| Norton Orthopaedic & Sports Medicine Specialists | |
| Louisville, Kentucky, United States, 40241 | |
| United States, New York | |
| Excelsior Orthopaedics | |
| Amherst, New York, United States, 14226 | |
| United States, Ohio | |
| Cincinnati Sports Medicine and Orthopeadic Center | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| United States, Texas | |
| Texas Center for Joint Replacement | |
| Plano, Texas, United States, 75093 | |
| United States, Utah | |
| Rimrock Orthopedics | |
| St. George, Utah, United States, 84790 | |
| Principal Investigator: | Samer S. Hasan, M.D. | Cincinnati Sports Medicine and Orthopaedic Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Encore Medical, L.P. |
| ClinicalTrials.gov Identifier: | NCT01005446 History of Changes |
| Other Study ID Numbers: | PS - 901 |
| Study First Received: | October 30, 2009 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013