Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Oslo University Hospital
Haukeland University Hospital
Sykehuset i Vestfold HF
Helse Stavanger HF
Sykehuset Telemark
Sykehuset Buskerud HF
Blefjell Hospital HF
Sykehuset Asker og Baerum
St. Olavs Hospital
University Hospital, Akershus
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00202735
First received: September 9, 2005
Last updated: May 7, 2009
Last verified: January 2005
  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 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.


Condition Intervention Phase
Shoulder Dislocation
Procedure: Arm1:Immobilization in external rotation
Procedure: immobilization in internal rotation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Reluxation [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Function,WOSI score,SIQ score [ Time Frame: Between second and third year after the primary dislocation. ] [ Designated as safety issue: No ]
  • Pain,Wosi score and SIQ score [ Time Frame: Between the second and third year after the primary dislocation ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: January 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immobilization in internal rotation

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
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.
Other Name: Immobilization in internal rotation
Experimental: 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
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.
Other Name: Immobilization in external rotation.

Detailed Description:

See earlier protocol in 2005

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Sorlandet Hospital HF
Oslo University Hospital
Haukeland University Hospital
Sykehuset i Vestfold HF
Helse Stavanger HF
Sykehuset Telemark
Sykehuset Buskerud HF
Blefjell Hospital HF
Sykehuset Asker og Baerum
St. Olavs Hospital
University Hospital, Akershus
Investigators
Study Chair: Svein Svenningsen, M.D. Sorlandet Hospital
  More Information

No publications provided

Responsible Party: Svein Svenningsen Dr.med, Sorlandet hospital HF
ClinicalTrials.gov Identifier: NCT00202735     History of Changes
Other Study ID Numbers: 811327
Study First Received: September 9, 2005
Last Updated: May 7, 2009
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

Additional relevant MeSH terms:
Dislocations
Recurrence
Shoulder Dislocation
Arm Injuries
Disease Attributes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014