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Completed

NCT Number: NCT00202735

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

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.

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Key information

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

See earlier protocol in 2005

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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. -

Treatment and study plan

Arm1:Immobilization in external rotation

Procedure

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.

Other names: Immobilization in external rotation.

immobilization in internal rotation

Procedure

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 outcomes

  1. Reluxation

    Time frame: After 2 years

Secondary outcomes

  1. Function,WOSI score,SIQ score

    Time frame: Between second and third year after the primary dislocation.

  2. Pain,Wosi score and SIQ score

    Time frame: Between the second and third year after the primary dislocation

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Blefjell Hospital HF
  • Haukeland University Hospital
  • Helse Stavanger HF
  • Oslo University Hospital
  • St. Olavs Hospital
  • Sykehuset Asker og Baerum
  • Sykehuset Buskerud HF
  • Sykehuset Telemark
  • Sykehuset i Vestfold HF
  • University Hospital, Akershus

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
May 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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