Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis
Withdrawn before enrolling · Not applicable
Conditions studied: Glenohumeral Osteoarthritis
In brief
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), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion. The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA. The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side. In all cases, a deltopectoral incision will be used as the procedure type.
Key facts
- Study ID
- NCT06513559
- Run by
- University of Utah
- People needed
- 0
- Starts
- 2023-08-02
- Expected to finish
- 2024-10-30
- Last updated by the study team
- 2025-02-28
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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,
Where it is running
- University of Utah Orthopedics — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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