This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. To reduce polyethylene wear, a new Shoulder System, mirroring the materials at the humeral/glenoid interface.
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function.
OrthoArizona
Gilbert, Arizona, United States
West Boca Medical Center
Boca Raton, Florida, United States
Andrews Research & Education Foundation
Gulf Breeze, Florida, United States
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint
The primary endpoint is clinical success, that will be determined if the following 4 criteria are met: No device-related serious adverse event have occurred, ASES score improved more than the Minimally Clinical Important Difference and is at least "fair", No radiological signs of implant subsidence, loosening or progressive radiolucency observed in the humeral or glenoid compartment, as defined in the Radiographic Evaluation Protocol, No revisions, removals, reoperations, or supplemental fixations.
Time frame: 24 months of follow up
Secondary objectives include the assessment of shoulder-specific function and overall health-related quality of life over time using validated patient-reported outcome measures.
The secondary endpoint at 24 months will be determined at the 6-week, 6-month, and 1-year timepoints. Radiographic evaluation and assessment, a 100-point patient-reported scale used to evaluate shoulder pain and daily function, 12 questions used to measure general physical/mental health from a patient's perspective (This is evaluated 0-100), Implant survival, and Adverse Events.
Time frame: 24 Months of follow up
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Foundation for Orthopedic Research and Education
Tampa, Florida, United States
Central Indiana Orthopedics
Fishers, Indiana, United States
Johns Hopkins - Washington
Columbia, Maryland, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Cornell Med NY
New York, New York, United States
Southern Oregon Orthopedics
Medford, Oregon, United States
Penn Medicine
Philadelphia, Pennsylvania, United States
...and 2 more locations