Dislocation of the ShoulderPhase 2NCT01648335
A Prospective Study of the Effect of Treatment of First Time Traumatic Shoulder Anterior Dislocation by Immobilization in External Rotation on the Incidence of Recurrent Dislocation
A Phase 2 study testing Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI) and Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) in people with Dislocation of the Shoulder, run by Hadassah Medical Organization.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men only
- Conditions the study is for
- Dislocation of the Shoulder
- What is being tested?
- Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI) and Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Dislocation of the Shoulder
- Being tested
- Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI), Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI)
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI)Device
Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI)Device
| Study group | Role | What they receive |
|---|---|---|
| immobilization of the shoulder in internal rotation | Active comparator | Not described Receives: Device: Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) |
| Immobilization of the shoulder in external rotation | Experimental | Not described Receives: Device: Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Number of recurrent dislocations within 6 months following the primary shoulder dislocation
Secondary outcomes (2)
• Range of motion of the dislocated shoulder after 6 months
Supine apprehensive test after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dislocation of the ShoulderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648335
- Sponsor's protocol ID
- beyth01-CTIL-HMO
- Status last verified
- Mar 2013
- First submitted
- 16 Jul 2012
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Effect of Treatment of First Time Traumatic Shoulder Anterior Dislocation by Immobilization in External Rotation on the Incidence of Recurrent Dislocation
- ClinicalTrials.gov ID
- NCT01648335
- Acronym / sponsor ID
- beyth01-CTIL-HMO
- Conditions
- Dislocation of the Shoulder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study completion
- Jul 2013
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immobilization of the shoulder in internal rotation | Active comparator | Device: Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) |
| Immobilization of the shoulder in external rotation | Experimental | Device: Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI) |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI) | Device | Immobilization of the shoulder in external rotation |
| Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) | Device | immobilization of the shoulder in internal rotation |
Primary outcome
• Number of recurrent dislocations within 6 months following the primary shoulder dislocation
2 secondary outcomes
• Range of motion of the dislocated shoulder after 6 months
Supine apprehensive test after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI) and Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) in people with Dislocation of the Shoulder, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Number of recurrent dislocations within 6 months following the primary shoulder dislocation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.