NCT05788614

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Jun 2022Jun 2026

Study Start

First participant enrolled

June 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

March 14, 2023

Last Update Submit

March 24, 2023

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

RSA-RV-30

EXPERIMENTAL
Device: Reverse shoulder arthroplasty

RSA-RV-0

EXPERIMENTAL
Device: Reverse shoulder arthroplasty

Interventions

Reverse shoulder arthroplastyDEVICE

Reverse shoulder arthroplasty

RSA-RV-0RSA-RV-30

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous surgeries in the shoulder
  • post-traumatic arthropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Reina Sofía de Córdoba

Córdoba, Cordoba, 14004, Spain

RECRUITING

Study Officials

  • Jose Carlos Minarro, Dr

    Hospital Universitario Reina Sofía de Córdoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Carlos Minarro, Dr

CONTACT

628653800josecarlosdiaz10@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 29, 2023

Study Start

June 30, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

ES(1)