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

NCT00202735 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2009-05-08

No results posted yet for this study

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.

Conditions

  • Shoulder Dislocation

Interventions

PROCEDURE

Arm1:Immobilization in external rotation

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.

PROCEDURE

immobilization in internal rotation

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.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER
  • Haukeland University Hospital

    collaborator OTHER
  • Sykehuset i Vestfold HF

    collaborator OTHER
  • Helse Stavanger HF

    collaborator OTHER_GOV
  • Sykehuset Telemark

    collaborator OTHER_GOV
  • Sykehuset Buskerud HF

    collaborator OTHER
  • Blefjell Hospital HF

    collaborator OTHER_GOV
  • Sykehuset Asker og Baerum

    collaborator OTHER
  • St. Olavs Hospital

    collaborator OTHER
  • University Hospital, Akershus

    collaborator OTHER
  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Svein Svenningsen, M.D. · Sorlandet Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

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Read the full study record

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View NCT00202735 on ClinicalTrials.gov