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
Primary Purpose
Dislocation of the Shoulder
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI)
Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI)
Sponsored by
About this trial
This is an interventional treatment trial for Dislocation of the Shoulder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
immobilization of the shoulder in internal rotation
Immobilization of the shoulder in external rotation
Arm Description
Outcomes
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
Full Information
NCT ID
NCT01648335
First Posted
July 16, 2012
Last Updated
March 21, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01648335
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2013 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dislocation of the Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
8. Arms, Groups, and Interventions
Arm Title
immobilization of the shoulder in internal rotation
Arm Type
Active Comparator
Arm Title
Immobilization of the shoulder in external rotation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI)
Intervention Type
Device
Intervention Name(s)
Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI)
Primary Outcome Measure Information:
Title
• Number of recurrent dislocations within 6 months following the primary shoulder dislocation
Secondary Outcome Measure Information:
Title
• Range of motion of the dislocated shoulder after 6 months
Title
Supine apprehensive test after 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
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
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