Retroversion in Reverse Shoulder Arthroplasty (RV-RSA)

March 24, 2023 updated by: José Carlos Minarro, Hospital Universitario Reina Sofia de Cordoba

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofía de Córdoba
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSA-RV-30
Device: Reverse shoulder arthroplasty
Reverse shoulder arthroplasty
Experimental: RSA-RV-0
Device: Reverse shoulder arthroplasty
Reverse shoulder arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Reina Sofia de Cordoba

Investigators

  • Principal Investigator: Jose Carlos Minarro, Dr, Hospital Universitario Reina Sofía de Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Anticipated)

June 30, 2026

Study Completion (Anticipated)

June 30, 2026

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUReinaSofia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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