Shoulder DislocationEPAULUXNCT05635240
Chronic Anterior Shoulder Instability in the Military
An observational study of Shoulder Dislocation, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
Trial summary
Anterior shoulder instability is a chronic condition that occurs after an anteromedial dislocation. Its prevalence is high in athletes but has been little studied in the armed forces. In general, patients with a first episode of dislocation have a 1 in 2 chance of experiencing at least one recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Interview / questionnaires
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2023to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of French military member with a first episode of true anterior glenohumeral shoulder dislocation.
Who may be able to join
- Military member with a first episode of true anterior glenohumeral shoulder dislocation,
- Male or female,
- Major,
- Having a sufficient level of reading/writing of the French language,
- Did not object to participating in the study.
Who cannot join
- Patient with a history of homolateral shoulder dislocation or surgery on the affected shoulder,
- Collagen disease confirmed by genetic testing,
- Inflammatory arthropathy,
- History of rotator cuff injury,
- Insufficient French reading/writing skills,
- Under legal protection,
- Objection to participating in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hôpital d'Instruction des Armées Percy
Clamart, 92140
Alexandre SABATE FERRIS, MD, alexandre.sabate-ferris@intradef.gouv.fr
Direction Médicale des Forces
Tours, 37076
Romain MONTAGNON, MD, 563245110 ext. +33, romain1.montagnon@intradef.gouv.fr
About this study
Anterior shoulder instability is a chronic condition that occurs after an anteromedial dislocation. Its prevalence is high in athletes but has been little studied in the armed forces. In general, patients with a first episode of dislocation have a 1 in 2 chance of experiencing at least one recurrence. The more recurrences there are, the more damage there is to the joint and the greater the disability for the patient. The decree determining the medical aptitude of military personnel emphasizes the need to have recourse to a specialized consultation to determine the classification of the soldier after a first episode of dislocation. In the absence of data collected specifically in the military population, classification is based on the surgeon's experience and extrapolation of results obtained in the general population.
- Conditions
- Shoulder Dislocation
- Being tested
- Interview / questionnaires
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview / questionnairesOther
At each of the 4 visits, the participant will have to answer several questions regarding trauma-related data, employment and sport practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a new episode of true anterior glenohumeral shoulder dislocation or subluxation 1 year after the initial dislocation.
A true anterior glenohumeral shoulder dislocation is defined as a dislocation requiring reduction.
Dislocation and subluxation will have to be objectified by medical examination
Measured: Through study completion (72 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study startSep 2023 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635240
- Sponsor's protocol ID
- 2019PPRC13
- Other IDs
- 2022-A02091-42
- Acronym
- EPAULUX
- Status last verified
- Apr 2023
- First submitted
- 23 Nov 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Anterior Shoulder Instability in the Military
- ClinicalTrials.gov ID
- NCT05635240
- Acronym / sponsor ID
- EPAULUX / 2019PPRC13
- Conditions
- Shoulder Dislocation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Dec 2022 (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.
Anterior shoulder instability is a chronic condition that occurs after an anteromedial dislocation. Its prevalence is high in athletes but has been little studied in the armed forces. In general, patients with a first episode of dislocation have a 1 in 2 chance of experiencing at least one recurrence. The more recurrences there are, the more damage there is to the joint and the greater the disability for the patient. The decree determining the medical aptitude of military personnel emphasizes the need to have recourse to a specialized consultation to determine the classification of the soldier after a first episode of dislocation. In the absence of data collected specifically in the military population, classification is based on the surgeon's experience and extrapolation of results obtained in the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of French military member with a first episode of true anterior glenohumeral shoulder dislocation.
Key inclusion criteria (5 listed)
- Military member with a first episode of true anterior glenohumeral shoulder dislocation,
- Male or female,
- Major,
- Having a sufficient level of reading/writing of the French language,
- Did not object to participating in the study.
Key exclusion criteria (7 listed)
- Patient with a history of homolateral shoulder dislocation or surgery on the affected shoulder,
- Collagen disease confirmed by genetic testing,
- Inflammatory arthropathy,
- History of rotator cuff injury,
- Insufficient French reading/writing skills,
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 |
|---|---|---|
| Interview / questionnairesAt each of the 4 visits, the participant will have to answer several questions regarding trauma-related data, employment and sport practice. | Other | – |
Primary outcome
Percentage of patients with a new episode of true anterior glenohumeral shoulder dislocation or subluxation 1 year after the initial dislocation.
Time frame: Through study completion (72 months)
A true anterior glenohumeral shoulder dislocation is defined as a dislocation requiring reduction. Dislocation and subluxation will have to be objectified by medical examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Dislocation, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre SABATE FERRIS, MD (141466000 ext. +33, alexandre.sabate-ferris@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a new episode of true anterior glenohumeral shoulder dislocation or subluxation 1 year after the initial dislocation. (time frame: Through study completion (72 months)). 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 28 Apr 2023.