Status:
COMPLETED
Retrospective Encore Reverse Shoulder Prosthesis Study
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Rotator Cuff Deficiency
Glenohumeral Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.
Eligibility Criteria
Inclusion
- The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
- The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
- The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
Exclusion
- Infection or sepsis
- Insufficient bone quality which may affect the stability of the implant, as determined by the physician
- Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
- Alcoholism or other addictions
- Materials (metals, etc) sensitivity
- Loss of ligamentous structures
- High levels of physical activity
- Non-functional deltoid muscle
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00765037
Start Date
August 1 2008
End Date
May 1 2009
Last Update
August 25 2010
Active Locations (1)
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1
Nashville Orthopedic Specialists
Nashville, Tennessee, United States, 37203