Dislocation of the Shoulder Clinical Trial
| Verified date | March 2013 |
| Source | Hadassah Medical Organization |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
Dislocation of the glenohumeral joint of the shoulder is a common orthopedic clinical
problem. The majority of the dislocations are anterior (about 95%) while the rest are
posterior and inferior. After reduction of the initial dislocation, the treatment's goal is
to prevent recurrent dislocations. In spite of treatment, the recurrence rate is 80-90% in
the population aged 18-29. There is an age-related decrease in the recurrence rate, with the
only 2-3% for ages 60-70. It has been calculated that 1 in 200 soldiers in the Israeli Army
between the ages of 17 and 33 suffers from recurrent shoulder dislocations [1].
The traditional treatment for primary (first-time) shoulder anterior dislocation has been
immobilization of the shoulder in internal rotation in a soft dressing called universal
shoulder immobilizer (USI) for 3-6 weeks. However, there is a lack of evidence-based
information to demonstrate the effectiveness of this treatment. Posterior dislocations are
immobilized in external rotation. Work presented previously in the Orthopaedic Research
Society and more recently at the American Academy of Orthopaedic Surgeons suggests that
immobilization of the shoulder after reduction of anterior dislocation is best in external
rotation and not in internal rotation. MRI studies have shown that the labral tear, which is
the hallmark of most traumatic anterior dislocations, is best reduced to its anatomical
position when the shoulder is immobilized in external and not in internal rotation.
Preliminary data indicates that immobilization in external rotation of the primary traumatic
shoulder dislocations may lower the incidence of reoccurrence.
The traditional shoulder immobilizer is a generic bandage produced by several companies. In
the current study, the investigators will use a USI distributed by Uriel® company (Uriel
#87), which can be modified to hold the shoulder in external rotation.
| Status | Not yet recruiting |
| Enrollment | 0 |
| Est. completion date | July 2013 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 29 Years |
| Eligibility |
Inclusion Criteria: - Male, age 18-29 - Diagnosis of anterior traumatic dislocation of the shoulder - First time dislocation with no history of prior shoulder instability before the present episode - Immobilization placed within 48 hours of the acute shoulder dislocation - Subject will be in available for 2 years of follow-up - Signed informed consent Exclusion Criteria: - Mechanism of injury - motor vehicle accident - Associated fracture of tuberosities or glenoid - Known Collagen disorder - Additional conditions that prevent inclusion of patient according to the physician's decision |
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | • Number of recurrent dislocations within 6 months following the primary shoulder dislocation | No | ||
| Secondary | • Range of motion of the dislocated shoulder after 6 months | No | ||
| Secondary | Supine apprehensive test after 6 months | No |