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Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
This study is currently recruiting participants.
Verified by Sorlandet Hospital HF, January 2005
Sponsored by: Sorlandet Hospital HF
Information provided by: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00202735
  Purpose

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 immobilisation 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 determing the risk of recurrence.There is no agreement according to the effect of immobilsation,neither to the length of immobilisation 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 immobilisation 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 immobilised in internal rotation for 3 weeks and the second group are immobilised in external rotation for 3 weeks.We will compare the rate of reluxation 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.


Condition Intervention Phase
Shoulder Dislocation
Procedure: Immobilisation in external or internal rotation
Phase II
Phase III

MedlinePlus related topics: Dislocations Shoulder Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Reluxation

Secondary Outcome Measures:
  • Function
  • Pain

Estimated Enrollment: 200
Study Start Date: January 2005
Estimated Study Completion Date: December 2009
  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202735

Contacts
Contact: Sigurd Liavaag, orthopae surg +47 370 14000 ext +47 970 47471 sigurd.liavaag@sshf.no
Contact: Svein Svenningsen, M.D +47 37014000 svein.svenningsen@sshf.no

Locations
Norway
Sorlandet Hospital HF Recruiting
Arendal, Norway, 4809
Contact: Sigurd Liavaag, Ortopaedic surgeon     +47 37014000     sigurd.liavaag@sshf.no    
Contact: Svein Svenningsen, M.D.     +47 370 14000     svein.svenningsen@sshf.no    
Principal Investigator: Sigurd Liavaag, M.D.            
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Chair: Svein Svenningsen, M.D. Sorlandet Hospital
  More Information

Study ID Numbers: 70327
Study First Received: September 9, 2005
Last Updated: February 27, 2006
ClinicalTrials.gov Identifier: NCT00202735  
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Sorlandet Hospital HF:
shoulder dislocation
anterior
traumatic
primary
first time
initial
immobilization
external
rotation

Study placed in the following topic categories:
Dislocations
Wounds and Injuries
Shoulder Dislocation
Disorders of Environmental Origin
Arm Injuries
Recurrence

ClinicalTrials.gov processed this record on January 15, 2009