Status:
COMPLETED
Reverse Shoulder Prosthesis Study
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Rotator Cuff Arthropathy
Failed Total Shoulder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results publis...
Eligibility Criteria
Inclusion
- Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
- Evidence of upward displacement of the humeral head with respect to the glenoid
- Loss of glenohumeral joint space
- Functional deltoid muscle
- Patient is likely to be available for evaluation for the duration of the study
- Visual Analog Pain Scale 5 or greater
Exclusion
- Non functional deltoid muscle
- Active sepsis
- Excessive glenoid bone loss
- Pregnancy
- Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
- Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
- Prisoners
- Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
- Known metal allergy (i.e., jewelry).
- Visual Analog Pain Scale \<5.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT00764504
Start Date
October 1 2002
End Date
August 1 2008
Last Update
April 19 2011
Active Locations (25)
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1
Arthritis Orthopedics and Sports Medicine
Glendale, California, United States, 91206
2
Orthopaedic Specialty Institute
Orange, California, United States, 92868
3
University of Colorado
Denver, Colorado, United States, 80054
4
Orthopedic Center of the Rockies
Fort Collins, Colorado, United States, 80525