Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sorlandet Hospital HF |
---|---|
Information provided by: | Sorlandet Hospital HF |
ClinicalTrials.gov Identifier: | NCT00202735 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Ages Eligible for Study: | 16 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts 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. -
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 |
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. |
Study Chair: | Svein Svenningsen, M.D. | Sorlandet Hospital |
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 |
shoulder dislocation anterior traumatic primary first time |
initial immobilization external rotation |
Dislocations Wounds and Injuries Shoulder Dislocation |
Disorders of Environmental Origin Arm Injuries Recurrence |