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A Prospective Study of the Effect of Treatment of First Time Traumatic Shoulder Anterior Dislocation by Immobilization in External Rotation on the Incidence of Recurrent Dislocation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648335
First Posted: July 24, 2012
Last Update Posted: March 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hadassah Medical Organization
  Purpose

Dislocation of the glenohumeral joint of the shoulder is a common orthopedic clinical problem. The majority of the dislocations are anterior (about 95%) while the rest are posterior and inferior. After reduction of the initial dislocation, the treatment's goal is to prevent recurrent dislocations. In spite of treatment, the recurrence rate is 80-90% in the population aged 18-29. There is an age-related decrease in the recurrence rate, with the only 2-3% for ages 60-70. It has been calculated that 1 in 200 soldiers in the Israeli Army between the ages of 17 and 33 suffers from recurrent shoulder dislocations [1].

The traditional treatment for primary (first-time) shoulder anterior dislocation has been immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) for 3-6 weeks. However, there is a lack of evidence-based information to demonstrate the effectiveness of this treatment. Posterior dislocations are immobilized in external rotation. Work presented previously in the Orthopaedic Research Society and more recently at the American Academy of Orthopaedic Surgeons suggests that immobilization of the shoulder after reduction of anterior dislocation is best in external rotation and not in internal rotation. MRI studies have shown that the labral tear, which is the hallmark of most traumatic anterior dislocations, is best reduced to its anatomical position when the shoulder is immobilized in external and not in internal rotation. Preliminary data indicates that immobilization in external rotation of the primary traumatic shoulder dislocations may lower the incidence of reoccurrence.

The traditional shoulder immobilizer is a generic bandage produced by several companies. In the current study, the investigators will use a USI distributed by Uriel® company (Uriel #87), which can be modified to hold the shoulder in external rotation.


Condition Intervention Phase
Dislocation of the Shoulder Device: Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI) Device: Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • • Number of recurrent dislocations within 6 months following the primary shoulder dislocation

Secondary Outcome Measures:
  • • Range of motion of the dislocated shoulder after 6 months
  • Supine apprehensive test after 6 months

Estimated Study Completion Date: July 2013
Arms Assigned Interventions
Active Comparator: immobilization of the shoulder in internal rotation Device: Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI)
Experimental: Immobilization of the shoulder in external rotation Device: Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI)

  Eligibility

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, age 18-29
  • Diagnosis of anterior traumatic dislocation of the shoulder
  • First time dislocation with no history of prior shoulder instability before the present episode
  • Immobilization placed within 48 hours of the acute shoulder dislocation
  • Subject will be in available for 2 years of follow-up
  • Signed informed consent

Exclusion Criteria:

  • Mechanism of injury - motor vehicle accident
  • Associated fracture of tuberosities or glenoid
  • Known Collagen disorder
  • Additional conditions that prevent inclusion of patient according to the physician's decision
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01648335     History of Changes
Other Study ID Numbers: beyth01-CTIL-HMO
First Submitted: July 16, 2012
First Posted: July 24, 2012
Last Update Posted: March 22, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Joint Dislocations
Shoulder Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries