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Clinical Trials/NCT05788614
NCT05788614
Recruiting
N/A

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

Hospital Universitario Reina Sofia de Cordoba1 site in 1 country90 target enrollmentJune 30, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Shoulder Osteoarthritis
Sponsor
Hospital Universitario Reina Sofia de Cordoba
Enrollment
90
Locations
1
Primary Endpoint
External rotation of the shoulder
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 30, 2022
End Date
June 30, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Universitario Reina Sofia de Cordoba
Responsible Party
Principal Investigator
Principal Investigator

José Carlos Minarro

Principal investigator

Hospital Universitario Reina Sofia de Cordoba

Eligibility Criteria

Inclusion Criteria

  • patients \> 60 years
  • primary rotator cuff arthropathy
  • implantation of reverse shoulder arthroplasty

Exclusion Criteria

  • previous surgeries in the shoulder
  • post-traumatic arthropathy

Outcomes

Primary Outcomes

External rotation of the shoulder

Time Frame: 2 years

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.

Constant-Murley Score

Time Frame: 2 years

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

Study Sites (1)

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