Comparing two shoulder surgeries for arthritis treatment
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis. a Randomized Prospective Study
This study is testing whether a new type of shoulder surgery can help people with arthritis just as much as the standard surgery over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | La Tour Hospital Academic / other |
| Locations | 1 site (Meyrin) |
| Trial ID | NCT04629391 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the functional outcomes of reverse total shoulder arthroplasty (RTSA) and total anatomic shoulder arthroplasty (TSA) in patients with primary glenohumeral osteoarthritis who have intact rotator cuffs. The study will assess whether RTSA can achieve results that are at least as good as TSA over a two-year period. Participants will be randomly assigned to receive either surgical intervention, and their progress will be monitored through clinical and radiographic evaluations. The goal is to provide evidence on the effectiveness of RTSA in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 to 85 with primary glenohumeral arthritis and intact rotator cuffs.
Not a fit: Patients with significant glenoid bone loss, full thickness rotator cuff tears, or other specified exclusions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective surgical approach for treating shoulder arthritis, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results comparing these two surgical approaches, but this trial aims to provide more definitive evidence through a prospective randomized design.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary glenohumeral arthritis, * Intact rotator cuff, * No important glenoid bone loss (cf exclusion criteria), * Patients between 65 and 85 years old * Informed Consent as documented by signature (Appendix Informed Consent Form). Exclusion Criteria: * 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, * Enrolment of the investigator, his/her family members, employees and other dependent persons.
Where this trial is running
Meyrin
- La Tour Hospital — Meyrin, Switzerland (Recruiting)
Study contacts
- Principal investigator: Alexandre Lädermann, MD — La Tour Hospital
- Study coordinator: Alexandre Lädermann, MD
- Email: alexandre.laedermann@gmail.com
- Phone: +41 22 719 75 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.