NCT05635240

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
40mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Sep 2023Sep 2029

First Submitted

Initial submission to the registry

November 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

November 23, 2022

Last Update Submit

April 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital d'Instruction des Armées Percy

Clamart, 92140, France

Location

Direction Médicale des Forces

Tours, 37076, France

Location

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Alexandre SABATE FERRIS, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 2, 2022

Study Start

September 1, 2023

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations