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NCT05788614 Clinical Trial

Retroversion in Reverse Shoulder Arthroplasty

Shoulder Osteoarthritis Clinical Trial

— RV-RSA  

Official title:
In a Reverse Shoulder Arthroplasty, Does Function Depend on the Humeral Version? A Prospective Randomized Study.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05788614
Other study ID # HUReinaSofia
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2022
Est. completion date June 30, 2026

Study information
Verified date March 2023
Source Hospital Universitario Reina Sofia de Cordoba
Contact Jose Carlos Minarro, Dr
Phone 628653800
Email josecarlosdiaz10@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare function in reverse shoulder arthroplasty (RSA) using two different degrees of humeral retroversion (RV). The main question it aims to answer is: • Does external rotation improves when using a higher retroversion? Participants will randomly receive a 0 degree or 30 degree RV for their RSA. They will be followed for two years and clinical outcomes will be recorded and analyzed.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - patients > 60 years - primary rotator cuff arthropathy - implantation of reverse shoulder arthroplasty Exclusion Criteria: - previous surgeries in the shoulder - post-traumatic arthropathy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Reverse shoulder arthroplasty
Reverse shoulder arthroplasty

Locations
Country Name City State
Spain Hospital Universitario Reina Sofía de Córdoba Córdoba Cordoba

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Reina Sofia de Cordoba

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary External rotation of the shoulder External rotation of the shoulder will be measured in degrees with the help of a goniometer in two ways.
First: External rotation 1 (ER1): arm adducted at zero degrees Second: External rotation 2 (ER2): arm in 90 degrees of abduction.		 2 years
Primary Constant-Murley Score The Constant-Murley score is a multi-item functional scale assessing pain, daily activities, range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively 2 years
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