Recruiting

Observational Study

Sponsor:

Hopital de l'Enfant-Jesus

Code:

NCT01111500

Conditions

Glenohumeral Joint Dislocation

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Donjoy ER brace

Thoraco brachial brace

Study Details

Brief summary:

Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of 1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed by an immobilization of the arm.

The purpose of the study is to evaluate the healing of the labrum in first time anterior glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an external rotation brace to an internal rotation brace to immobilize the injured arm.

Conditions

Glenohumeral Joint Dislocation

Study ID

NCT01111500

Start date

Jul, 2007

Status verified date

Dec, 2012

Completion date

Feb, 2015

Anticipated

Primary completion date

Feb, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • > 18 years old
  • < 40 years old
  • anterior glenohumeral joint dislocation proved by radiography
  • dislocation needing a reduction manoeuvre
  • home close to evaluation site for 24 months follow-up visits
  • signed consent form

Exclusion Criteria:

  • associated fracture
  • Hill-Sachs lesion = or > than 30%
  • neurovascular deficit
  • hypermobility
  • pre-existing instability of the injured shoulder
  • systemic neurological disease
  • allergy to gadolinium
  • functional sequel to the shoulder due to previous injury
  • incapacitated adult patient
  • minor patient
  • home far from evaluation site
  • refusal to sign the consent form

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: external rotation immobilization

Patient will wear an external rotation brace to immobilize the injured arm.

active comparator: internal rotation immobilization

Patient will wear an internal rotation brace to immobilize the injured arm.

Interventions

Donjoy ER brace

Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.

Thoraco brachial brace

Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.

Primary outcome measure

  • Anatomical healing of the labrum [ Time Frame: 3 months after dislocation ]

Central Contacts and Locations

Central contacts

Hélène Côté, Res Nurse

1-418-649-0252helco3@hotmail.com

Stéphane Pelet, MD, PhD

1-418-649-0252stephane.pelet.ortho@gmail.com

Locations

CHA-Pavillon Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Stéphane Pelet, MD, PhD

1-418-649-0252stephane.pelet.ortho@gmail.com

More Information

Sponsor

Hopital de l'Enfant-Jesus

Last update posted

Dec 20, 2012

Last verified

Dec, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hopital de l'Enfant-Jesus on 2012-12-20.