This is a multi-center study assessing postoperative outcomes associated with hemiarthroplasty with pyrocarbon (hPYC) versus anatomic total shoulder arthroplasty (aTSA). Once eligibility criteria is met, the subject will be randomized to one of the two study arms. Subjects will be followed for ten years. Clinical and patient-reported outcome measures (PROMs) will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
Hemiarthroplasty with pyrocarbon
Anatomic total shoulder arthroplasty
Washington University
St Louis, Missouri, United States
Single Assessment Numeric Evaluation score
Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.
Time frame: 2-years
American Shoulder and Elbow Visual Analog Pain Score
Assess pain relief. Range: 0-10. Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Forgotten Joint score
Assess shoulder function. The total score ranges from 0 to 100 with higher scores indicating a high degree of forgetting the artificial joint.
Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Range of motion
Assess shoulder motion. Subjects will have their shoulder range of motion measured in degrees.
Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years
Assess rates of glenoid erosion
Assess rates of glenoid erosion associated with pyrocarbon hemiarthroplasty
Time frame: 2-years, 5-years, 10-years
Assess rates of aseptic glenoid loosening
Assess rates of aseptic glenoid loosening associated with anatomic total shoulder arthroplasty
Time frame: 2-years, 5-years, 10-years
Single Assessment Numeric Evaluation Score
Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.
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Time frame: 5-years, 10-years