EPAULUX: Chronic Anterior Shoulder Instability in the Military

• Sponsor: Direction Centrale du Service de Santé des Armées (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05635240
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Anticipated Duration (Months): 72
• Patients Per Site: 60
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Other: Interview / questionnaires

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Chronic Anterior Shoulder Instability in the Military
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2028
• Anticipated Study Completion Date: Dec 1, 2028

Outcome Measures

Primary Outcome Measures

1. Percentage of patients with a new episode of true anterior glenohumeral shoulder dislocation or subluxation 1 year after the initial dislocation. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital d'Instruction des Armées Percy	Clamart		France	92140
2	Direction Médicale des Forces	Tours		France	37076

Sponsors and Collaborators

• Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Direction Centrale du Service de Santé des Armées
• ClinicalTrials.gov Identifier: NCT05635240
• Other Study ID Numbers: 2019PPRC13; 2022-A02091-42
• First Posted: Dec 2, 2022
• Last Update Posted: Dec 2, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shoulder Dislocation

Study Results

No Results Posted as of Dec 2, 2022