Status:
WITHDRAWN
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis
Lead Sponsor:
University of Utah
Conditions:
Glenohumeral Osteoarthritis
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), i...
Detailed Description
Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening...
Eligibility Criteria
Inclusion
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf exclusion criteria),
- Patients between 60 and 85 years old (based on indications for RTSA)
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion
- B2 glenoid with \> 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
- B3 and C type glenoids,
- Full thickness rotator cuff tear,
- Acute or malunited proximal humeral fracture,
- Chronic locked dislocation
- Rheumatoid arthritis,
- Revision surgery or surgical antecedents,
- Tumors,
- Axillary nerve damage,
- Non-functioning deltoid muscle,
- Glenoid vault deficiency precluding baseplate fixation,
- Infection and neuropathic joints,
- Known or suspected non-compliance, drug or alcohol abuse,
- Patients incapable of judgement or under tutelage,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06513559
Start Date
August 2 2023
End Date
October 30 2024
Last Update
February 28 2025
Active Locations (1)
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1
University of Utah Orthopedics
Salt Lake City, Utah, United States, 84108