Trial record 3 of 3 for:    Open Studies | "Shoulder Dislocation"

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
  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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • 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 ]

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

Ages Eligible for Study:   18 Years to 29 Years
Genders 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

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01648335     History of Changes
Other Study ID Numbers: beyth01-CTIL-HMO
Study First Received: July 16, 2012
Last Updated: March 21, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Dislocations
Shoulder Dislocation
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 17, 2014