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

Tracking Information
First Submitted Date ICMJE	July 16, 2012
First Posted Date ICMJE	July 24, 2012
Last Update Posted Date	March 22, 2013
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: July 19, 2012)	• Number of recurrent dislocations within 6 months following the primary shoulder dislocation
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01648335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 19, 2012)	• Range of motion of the dislocated shoulder after 6 months; Supine apprehensive test after 6 months
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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
Official Title ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition ICMJE	Dislocation of the Shoulder
Intervention ICMJE	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)
Study Arms	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study Completion Date	July 2013
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 29 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01648335
Other Study ID Numbers ICMJE	beyth01-CTIL-HMO
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hadassah Medical Organization
Study Sponsor ICMJE	Hadassah Medical Organization
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Hadassah Medical Organization
Verification Date	March 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP