Comparing two types of reverse shoulder arthroplasty for rotator cuff issues
Clinical Study to Analyze the Functional, Radiological, and Strength Results in Lateralized Models and Inverted Arthroplasty Medializations
This study is testing two different types of shoulder surgeries to see which one helps older patients with rotator cuff problems feel and move better after their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05847062 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the functional outcomes, complications, and muscle performance associated with two different reverse shoulder arthroplasty systems: one with a medialized center of rotation and the other with a lateralized center of rotation. It is a prospective, unblinded, randomized, comparative trial involving patients over 65 years old who have rotator cuff arthropathy that has not improved with conservative treatment. Participants will be randomly assigned to one of the two groups, and their outcomes will be measured using the Constant scale to determine any significant differences in performance. The study seeks to enroll a total of 42 patients to ensure adequate statistical power for the analysis.
Who should consider this trial
Good fit: Ideal candidates are male or female patients over 65 years old with rotator cuff arthropathy that has not responded to conservative treatment for at least six months.
Not a fit: Patients with specific conditions such as rheumatoid arthritis, avascular necrosis, or significant glenoid bone defects may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and rehabilitation for patients with rotator cuff arthropathy.
How similar studies have performed: While this approach is based on existing concepts, the specific comparison of medialized versus lateralized centers of rotation in reverse shoulder arthroplasty is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients over 65 years of age with rotator cuff arthropathy refractory to conservative treatment after six months. 2. Ability to understand the information sheet, informed consent and evaluation scales. Exclusion Criteria: Patients with sequelae of fractures, rheumatoid arthritis, avascular necrosis, primary glenohumeral arthrosis, revision surgeries that have required conversion to a ATHI 3. Patients in whom another surgical procedure has been associated with ATHI such as a tendon transfer 4. Glenoid bone defects in the horizontal plane (Type B2 and C of the Walch classification) or in the vertical plane (E3 Sirveaux).
Where this trial is running
Madrid
- Hospital Clinico San Carlos de Madrid — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Yaiza Lopiz Morales, professor
- Email: yaizalopiz@gmail.com
- Phone: +34 609564029
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.