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Retroversion in Reverse Shoulder Arthroplasty (RV-RSA)

Primary Purpose

Shoulder Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Reverse shoulder arthroplasty
Sponsored by
Hospital Universitario Reina Sofia de Cordoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Osteoarthritis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: patients > 60 years primary rotator cuff arthropathy implantation of reverse shoulder arthroplasty Exclusion Criteria: previous surgeries in the shoulder post-traumatic arthropathy

Sites / Locations

  • Hospital Universitario Reina Sofía de CórdobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RSA-RV-30

RSA-RV-0

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
March 14, 2023
Last Updated
March 24, 2023
Sponsor
Hospital Universitario Reina Sofia de Cordoba
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1. Study Identification

Unique Protocol Identification Number
NCT05788614
Brief Title
Retroversion in Reverse Shoulder Arthroplasty
Acronym
RV-RSA
Official Title
In a Reverse Shoulder Arthroplasty, Does Function Depend on the Humeral Version? A Prospective Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Reina Sofia de Cordoba

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RSA-RV-30
Arm Type
Experimental
Arm Title
RSA-RV-0
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Reverse shoulder arthroplasty
Intervention Description
Reverse shoulder arthroplasty
Primary Outcome Measure Information:
Title
External rotation of the shoulder
Description
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.
Time Frame
2 years
Title
Constant-Murley Score
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Carlos Minarro, Dr
Phone
628653800
Ext
+34
Email
josecarlosdiaz10@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carlos Minarro, Dr
Organizational Affiliation
Hospital Universitario Reina Sofía de Córdoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía de Córdoba
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Carlos Minarro, M.D. Ph.D
Phone
+34 628653800
Email
josecarlosdiaz10@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Retroversion in Reverse Shoulder Arthroplasty

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