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

NCT00202735 | Completed Phase 2 DMC

• 1 other identifier: 811327
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Dislocation

Keywords

shoulder dislocation; anterior; traumatic; primary; first time; initial; immobilization; external; rotation

Outcome Measures

Primary Outcomes (1)

• Reluxation

  After 2 years

Secondary Outcomes (2)

• Function,WOSI score,SIQ score

  Between second and third year after the primary dislocation.

• Pain,Wosi score and SIQ score

  Between the second and third year after the primary dislocation

Study Arms (2)

Immobilization in internal rotation

ACTIVE COMPARATOR

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.

Procedure: immobilization in internal rotation

Immobilization in external rotation.

EXPERIMENTAL

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

Procedure: Arm1:Immobilization in external rotation

Interventions

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.

Immobilization in internal rotation

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.

Also known as: Immobilization in external rotation.

Immobilization in external rotation.

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

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

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Svein Svenningsen, M.D.

  Sorlandet Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 8, 2009

Record last verified: 2005-01