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

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202735
• Other study ID #: 811327
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: May 7, 2009
• Start date: January 2005
• Est. completion date: February 2008

Study information

• Verified date: January 2005
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Description:

See earlier protocol in 2005

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Shoulder Dislocation

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (11)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reluxation		After 2 years	No
Secondary	Function,WOSI score,SIQ score		Between second and third year after the primary dislocation.	No
Secondary	Pain,Wosi score and SIQ score		Between the second and third year after the primary dislocation	No