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Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Arm1:Immobilization in external rotation
immobilization in internal rotation
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring shoulder dislocation, anterior, traumatic, primary, first time, initial, immobilization, external, rotation

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient has a first time traumatic anterior dislocation of the shoulder. The dislocation is verified by x-ray examination. The patient is aged between 16 and 40 years. - Exclusion Criteria: An osseous defect of the anterior glenoid rim in which the length is at least 20% and the width at least 1/3 of the the length of the anterior bony glenoid rim. A fracture of tuberculum majus which do not fall into place after manually reduction of the dislocated shoulder.(That means more than 1 cm diastase) Damage of the axillary nerve or plexus The patient is not able to or willing to participate in the study. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Immobilization in internal rotation

    Immobilization in external rotation.

    Arm Description

    Immobilization in internal rotation:All patients in this group are immobilized with the arm in internal rotation. The arm is immobilized with a normal collar and cuff device.

    Immobilization in external rotation (ER. All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling ER, 15˚ version.To control the position, a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed

    Outcomes

    Primary Outcome Measures

    Reluxation

    Secondary Outcome Measures

    Function,WOSI score,SIQ score
    Pain,Wosi score and SIQ score

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    May 7, 2009
    Sponsor
    Sorlandet Hospital HF
    Collaborators
    Oslo University Hospital, Haukeland University Hospital, Sykehuset i Vestfold HF, Helse Stavanger HF, Sykehuset Telemark, Sykehuset Buskerud HF, Blefjell Hospital HF, Sykehuset Asker og Baerum, St. Olavs Hospital, University Hospital, Akershus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00202735
    Brief Title
    Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
    Official Title
    Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    February 2008 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sorlandet Hospital HF
    Collaborators
    Oslo University Hospital, Haukeland University Hospital, Sykehuset i Vestfold HF, Helse Stavanger HF, Sykehuset Telemark, Sykehuset Buskerud HF, Blefjell Hospital HF, Sykehuset Asker og Baerum, St. Olavs Hospital, University Hospital, Akershus

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Dislocation of the glenohumeral joint is the most common traumatic joint dislocation. The usual treatment of first time traumatic anterior dislocation of the shoulder is reduction followed by immobilization in a sling for a period of one to three weeks. The incidence of recurrence is high and age at the time of primary dislocation is the chief prognostic factor in determining the risk of recurrence. There is no agreement according to the effect of immobilization,neither to the length of immobilization time. The Bankart lesion with avulsion of the inferior-anterior capsulolabral complex is almost invariably present in patients with anterior shoulder dislocation. Recent and ongoing studies by Eijii Itoi et al,Akita university Japan, gives evidence of the immobilization with the arm held in external rotation may reduce the risk of subsequent instability by approximating the Bankart lesion to the neck of the glenoid giving a more anatomical healing. We have started a prospective randomized study. The patients are assigned to two groups with informed consent. One group are immobilized in internal rotation for 3 weeks and the second group are immobilized in external rotation for 3 weeks. We will compare the rate of relaxation between the groups. Because age is the main prognostic factor we use stratified randomization with two age groups: One group of patients aged between 16 and 24 years and one group aged between 25 and 40 years.The time of observation after initial treatment will be 2 years with follow up after 4 and 10 years. Eleven hospitals and two primary trauma care centers in Norway participate in the study. A subgroup of 50 patients are also planned to be examined with CT and MRI.
    Detailed Description
    See earlier protocol in 2005

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Dislocation
    Keywords
    shoulder dislocation, anterior, traumatic, primary, first time, initial, immobilization, external, rotation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    188 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immobilization in internal rotation
    Arm Type
    Active Comparator
    Arm Description
    Immobilization in internal rotation:All patients in this group are immobilized with the arm in internal rotation. The arm is immobilized with a normal collar and cuff device.
    Arm Title
    Immobilization in external rotation.
    Arm Type
    Experimental
    Arm Description
    Immobilization in external rotation (ER. All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling ER, 15˚ version.To control the position, a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed
    Intervention Type
    Procedure
    Intervention Name(s)
    Arm1:Immobilization in external rotation
    Other Intervention Name(s)
    Immobilization in external rotation.
    Intervention Description
    Immobilization in external rotation (ER) All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling Er,15˚ version).To control the position,a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed in 15 degrees of external rotation.
    Intervention Type
    Procedure
    Intervention Name(s)
    immobilization in internal rotation
    Intervention Description
    All the patients in the internal rotation(IR) group are immobilized with their arm/shoulder in internal rotation by using a normal collar and cuff device.
    Primary Outcome Measure Information:
    Title
    Reluxation
    Time Frame
    After 2 years
    Secondary Outcome Measure Information:
    Title
    Function,WOSI score,SIQ score
    Time Frame
    Between second and third year after the primary dislocation.
    Title
    Pain,Wosi score and SIQ score
    Time Frame
    Between the second and third year after the primary dislocation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient has a first time traumatic anterior dislocation of the shoulder. The dislocation is verified by x-ray examination. The patient is aged between 16 and 40 years. - Exclusion Criteria: An osseous defect of the anterior glenoid rim in which the length is at least 20% and the width at least 1/3 of the the length of the anterior bony glenoid rim. A fracture of tuberculum majus which do not fall into place after manually reduction of the dislocated shoulder.(That means more than 1 cm diastase) Damage of the axillary nerve or plexus The patient is not able to or willing to participate in the study. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Svein Svenningsen, M.D.
    Organizational Affiliation
    Sorlandet Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?

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