Clinical trial NCT00202735: Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
Official title: Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Shoulder Dislocation
Keywords: shoulder dislocation
anterior
traumatic
primary
first time
initial
immobilization
external
rotation
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
name: Haukeland University Hospital
name: Sykehuset i Vestfold HF
name: Helse Stavanger HF
name: Sykehuset Telemark
name: Sykehuset Buskerud HF
name: Blefjell Hospital HF
name: Sykehuset Asker og Baerum
name: St. Olavs Hospital
name: University Hospital, Akershus
First posted: 2005-09-20
Enrollment: 188
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

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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. -

Primary outcomes:
measure: Reluxation
timeFrame: After 2 years
Secondary outcomes:
measure: Function,WOSI score,SIQ score
timeFrame: Between second and third year after the primary dislocation.
measure: Pain,Wosi score and SIQ score
timeFrame: Between the second and third year after the primary dislocation
Other outcomes:
Locations:
Study officials:
affiliation: Sorlandet Hospital
name: Svein Svenningsen, M.D.
role: STUDY_CHAIR
References: