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

This study is not yet open for participant recruitment.
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01648335
First received: July 16, 2012
Last updated: March 21, 2013
Last verified: March 2013

July 16, 2012
March 21, 2013
Not Provided
Not Provided
• Number of recurrent dislocations within 6 months following the primary shoulder dislocation [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01648335 on ClinicalTrials.gov Archive Site
  • • Range of motion of the dislocated shoulder after 6 months [ Designated as safety issue: No ]
  • Supine apprehensive test after 6 months [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Not Provided

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.

Not Provided
Interventional
Phase 2
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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)
  • Active Comparator: immobilization of the shoulder in internal rotation
    Intervention: 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
    Intervention: Device: Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
Not Provided
July 2013
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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
Male
18 Years to 29 Years
No
Not Provided
Not Provided
 
NCT01648335
beyth01-CTIL-HMO
No
Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP