Shoulder OsteoarthritisRV-RSANCT05788614
Retroversion in Reverse Shoulder Arthroplasty
A study testing Reverse shoulder arthroplasty in people with Shoulder Osteoarthritis, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- Reverse shoulder arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients > 60 years
- primary rotator cuff arthropathy
- implantation of reverse shoulder arthroplasty
Who cannot join
- previous surgeries in the shoulder
- post-traumatic arthropathy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Cordoba, 14004
José Carlos Minarro, M.D. Ph.D, +34 628653800, josecarlosdiaz10@gmail.com
About this study
Official title: 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.
- Conditions
- Shoulder Osteoarthritis
- Being tested
- Reverse shoulder arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse shoulder arthroplastyDevice
Reverse shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| RSA-RV-30 | Experimental | Not described Receives: Device: Reverse shoulder arthroplasty |
| RSA-RV-0 | Experimental | Not described Receives: Device: Reverse shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start30 Jun 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Responsible party
- Principal investigator, José Carlos Minarro, Hospital Universitario Reina Sofia de Cordoba
- Investigators
- Jose Carlos Minarro, Dr, Principal investigator, Hospital Universitario Reina Sofía de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788614
- Sponsor's protocol ID
- HUReinaSofia
- Acronym
- RV-RSA
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In a Reverse Shoulder Arthroplasty, Does Function Depend on the Humeral Version? A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT05788614
- Acronym / sponsor ID
- RV-RSA / HUReinaSofia
- Conditions
- Shoulder Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSA-RV-30 | Experimental | Device: Reverse shoulder arthroplasty |
| RSA-RV-0 | Experimental | Device: Reverse shoulder arthroplasty |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients > 60 years
- primary rotator cuff arthropathy
- implantation of reverse shoulder arthroplasty
Key exclusion criteria (2 listed)
- previous surgeries in the shoulder
- post-traumatic arthropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse shoulder arthroplastyReverse shoulder arthroplasty | Device | RSA-RV-0, RSA-RV-30 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Carlos Minarro, Dr principal investigator
Hospital Universitario Reina Sofía de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse shoulder arthroplasty in people with Shoulder Osteoarthritis, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Carlos Minarro, Dr (628653800 ext. +34, josecarlosdiaz10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External rotation of the shoulder (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.