A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.
The purpose of this study is to demonstrate non-inferiority of the Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. Non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
303
Control
Investigational
Banner Research
Sun City, Arizona, United States
Orthopedics Stanford University
Redwood City, California, United States
Composite Clinical Success
To be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is \> or = to 10 and a final Adjusted Constant Score \> or + to 54. 2. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. 3. No reoperation, removal or modification of any study component up to the subject's completion of the study. 4. No serious device-related complications up to the subject's completion of the study.
Time frame: 2 year
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