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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ClinicalTrials.gov Identifier: NCT01648335 |
Recruitment Status
: Unknown
Verified March 2013 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted
: July 24, 2012
Last Update Posted
: March 22, 2013
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Tracking Information | |||
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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 |
• 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 |
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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. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Intervention Model: Parallel Assignment Primary Purpose: Treatment |
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Condition ICMJE | Dislocation of the Shoulder | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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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:
Exclusion Criteria:
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Sex/Gender |
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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 |