Chronic Anterior Shoulder Instability in the Military

Shoulder Dislocation Clinical Trial

— EPAULUX  

Official title:

Chronic Anterior Shoulder Instability in the Military

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05635240
• Other study ID #: 2019PPRC13
• Secondary ID: 2022-A02091-42
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2029

Study information

• Verified date: April 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Alexandre SABATE FERRIS, MD
• Phone: 141466000
• Email: alexandre.sabate-ferris[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Other:
• Interview / questionnaires
At each of the 4 visits, the participant will have to answer several questions regarding trauma-related data, employment and sport practice.

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées Percy	Clamart
France	Direction Médicale des Forces	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion (72 months)