Chronic Anterior Shoulder Instability in the Military (EPAULUX)

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 Overview

• Status: Not yet recruiting
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Other: Interview / questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Alexandre SABATE FERRIS, MD; Phone Number: +33 141466000; Email: alexandre.sabate-ferris@intradef.gouv.fr

Study Locations

• France
  • Clamart, France, 92140
    • Hopital D'Instruction Des Armees Percy
    • Contact: Alexandre SABATE FERRIS, MD; Email: alexandre.sabate-ferris@intradef.gouv.fr
  • Tours, France, 37076
    • Direction Médicale des Forces
    • Contact: Romain MONTAGNON, MD; Phone Number: +33 563245110; Email: romain1.montagnon@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of French military member with a first episode of true anterior glenohumeral shoulder dislocation.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): September 1, 2029
• Study Completion (Anticipated): September 1, 2029

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: 2019PPRC13; 2022-A02091-42 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No