Rotator Cuff TearsNCT06316050
Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty
A study testing humeral retroversion in people with Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- What is being tested?
- humeral retroversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2018to 28 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria
- Good functionality of the deltoid muscle.
- Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
- Accept informed consent
Who cannot join
- - Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
- Fracture of shoulder in the upper extremity to intervene.
- Central neurological diseases
- Advanced cognitive impairment
- Brachial plexus injuries
- Local or systemic infection.
- Oncological disease
- Treatment with immunosuppressants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrovertion Assesment and Study of the Subscapularis Function in Elderly Patients With Reverse Total Shoulder Arthroplasty
Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.
Read the detailed description
Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- Being tested
- humeral retroversion
- Medical subject headings
- Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humeral retroversionProcedure or surgery
REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion
| Study group | Role | What they receive |
|---|---|---|
| humeral retroversion 0º | Active comparator | will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital Receives: Procedure: humeral retroversion |
| humeral retroversion 30º | No intervention | will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTERNAL ROTATION
AT THE SIDE (HAND TO the BACK from CONSTANT TEST)
Measured: 2 YEARS
INTERNAL ROTATION
degrees
Measured: 2 YEARS
Secondary outcomes (10)
EXTERNAL ROTATION
degrees
Measured: 2 YEARS
FORWARD ELEVATION
degrees
Measured: 2 YEARS
Simple shoulder test
0-100
Measured: 2 years
Constant test
0-100
Measured: 2 years
ASES test
0-100
Measured: 2 years
Glenoid inclination angle
degrees
Measured: 2 years
glenoid retroversion angle
degrees
Measured: 2 years
abduction
degrees
Measured: 2 years
center of rotation
milimiters
Measured: 2 years
lateralizaiton offset
milimiters
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 posted18 Mar 2024
- Study start1 Aug 2018
- Primary completion31 Aug 2021
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Maria Mora Guix, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316050
- Sponsor's protocol ID
- cst
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrovertion Assesment and Study of the Subscapularis Function in Elderly Patients With Reverse Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06316050
- Acronym / sponsor ID
- cst
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 18 Mar 2024 (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.
Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.
Detailed description
Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| humeral retroversion 0º | Active comparator | Procedure: humeral retroversionwill be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital |
| humeral retroversion 30º | No intervention | –will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria
- Good functionality of the deltoid muscle.
- Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
- Accept informed consent
Key exclusion criteria (8 listed)
- - Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
- Fracture of shoulder in the upper extremity to intervene.
- Central neurological diseases
- Advanced cognitive impairment
- Brachial plexus injuries
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 |
|---|---|---|
| humeral retroversionREVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion | Procedure or surgery | humeral retroversion 0º |
Primary outcome
INTERNAL ROTATION
Time frame: 2 YEARS
AT THE SIDE (HAND TO the BACK from CONSTANT TEST)
INTERNAL ROTATION
Time frame: 2 YEARS
degrees
10 secondary outcomes
EXTERNAL ROTATION
Time frame: 2 YEARS
FORWARD ELEVATION
Time frame: 2 YEARS
Simple shoulder test
Time frame: 2 years
Constant test
Time frame: 2 years
ASES test
Time frame: 2 years
Glenoid inclination angle
Time frame: 2 years
glenoid retroversion angle
Time frame: 2 years
abduction
Time frame: 2 years
center of rotation
Time frame: 2 years
lateralizaiton offset
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing humeral retroversion in people with Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, run by Consorci Sanitari de Terrassa 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 18 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INTERNAL ROTATION (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 18 Mar 2024.