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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
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dislocation of the Shoulder

Eligibility Criteria

18 Years - 29 Years (Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    July 16, 2012
    Last Updated
    March 21, 2013
    Sponsor
    Hadassah Medical Organization
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    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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