Glenohumeral Osteoarthritis
Conditions
Keywords
hemiarthroplasty, anatomic total shoulder arthroplasty, pyrocarbon
Brief summary
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.
Interventions
DEVICEHemiarthroplasty with pyrocarbon
Hemiarthroplasty with pyrocarbon
Anatomic total shoulder arthroplasty
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Fluent in English language 2. Willing to sign an informed consent form 3. Willing to comply with all study procedures and be available for the duration of the study 4. Age 40 to 65 years 5. In good general health as evidenced by medical history 6. Surgical indication of glenohumeral osteoarthritis 7. In the opinion of the surgeon, there is clinical equipoise for the subject to be implanted with a humeral hemiarthroplasty with pyrocarbon or anatomic total shoulder arthroplasty
Exclusion criteria
1. Presence of Walch Type C or D glenoid 2. Presence of a glenoid that could not be reconstructed with the anatomic glenoid resurfacing components 3. Presence of extreme preoperative glenoid deformity including uniplanar retroversion deformity \>30 o or severe biplanar deformity (retroversion \>20 o and inclination \> 10 o). 4. Workers' compensation case 5. Presence of full-thickness rotator cuff tear 6. Known allergic reactions to components of the study product(s) 7. History of consistent narcotic use within three months of surgery 8. History of chronic oral corticosteroid use 9. History or current drug or alcohol abuse 10. In the surgeon's opinion, the subject will be non-compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Assessment Numeric Evaluation score | 2-years | Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Visual Analog Pain Score | 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years | Assess pain relief. Range: 0-10. Zero is equivalent to no pain and 10 indicates the worst possible pain |
| Forgotten Joint score | 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years | Assess shoulder function. The total score ranges from 0 to 100 with higher scores indicating a high degree of forgetting the artificial joint. |
| Range of motion | 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years | Assess shoulder motion. Subjects will have their shoulder range of motion measured in degrees. |
| Assess rates of glenoid erosion | 2-years, 5-years, 10-years | Assess rates of glenoid erosion associated with pyrocarbon hemiarthroplasty |
| Assess rates of aseptic glenoid loosening | 2-years, 5-years, 10-years | Assess rates of aseptic glenoid loosening associated with anatomic total shoulder arthroplasty |
| Single Assessment Numeric Evaluation Score | 5-years, 10-years | Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Zmistowski, MD
Washington University School of Medicine
Outcome results
None listed