Skip to content

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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00202735
Enrollment
188
Registered
2005-09-20
Start date
2005-01-31
Completion date
2008-02-29
Last updated
2009-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

Keywords

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

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.

Detailed description

See earlier protocol in 2005

Interventions

PROCEDUREArm1: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.

PROCEDUREimmobilization 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frame
ReluxationAfter 2 years

Secondary

MeasureTime frame
Function,WOSI score,SIQ scoreBetween second and third year after the primary dislocation.
Pain,Wosi score and SIQ scoreBetween the second and third year after the primary dislocation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026