Primary Anterior Shoulder DislocationEERAADSNCT02197819
A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
A study testing Sling and External Rotation Brace in people with Primary Anterior Shoulder Dislocation, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2% in the general population. In young patients, recurrence after a primary dislocation is also common (~60%) and multiple recurrent episodes can cause significant disability over time. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Primary Anterior Shoulder Dislocation
- What is being tested?
- Sling and External Rotation Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2013to 1 Feb 2018
- Phase
- Interventional
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Skeletally mature patients between 18 - 35 years of age inclusive
- Patient is seen within 24 hours from time of injury.
- Sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by;
- Mechanism of abduction, external rotation
- Sudden pain in the shoulder
- Manipulative reduction required or
- Radiograph documenting a dislocated joint
- Willing to participate in follow-up for at least 24 months.
Who cannot join
- Incompetent or unwilling to consent
- Inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments.
- Previous instability of the affected shoulder
- Significant associated fracture (Exception Hill Sachs or bankart lesions)
- Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
- Neurovascular compromise of the affected limb
- A medical condition making the patient unable to wear a brace or sling
- Patient is seen within 24 hours from time of injury
Trial locations and contacts
1 site in 1 country.
About this study
Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2% in the general population. In young patients, recurrence after a primary dislocation is also common (~60%) and multiple recurrent episodes can cause significant disability over time. Following initial reduction of the joint, the traditional treatment for primary shoulder dislocations has been immobilization in a sling, with the arm in a position of adduction and internal rotation. The length of the immobilization period is controversial, however most authors would recommend between three to six weeks in a sling followed by several months of rehabilitation to include range of motion and strengthening exercises. The clinical course of patients after this approach has been extensively investigated. Of particular interest is the relatively high rate of recurrent instability in young patients, reported to be between 17 and 96%.
A prospective randomized trial is needed to determine whether in young patients (16-30 yrs of age) following reduction of a first-time traumatic anterior shoulder dislocation, does EMERGENT (<4 hours post reduction) immobilization of the affected shoulder in external rotation reduce the rate of recurrent instability experienced within 12 months versus emergent immobilization in a traditional internal rotation sling? Eligible patients will be randomly allocated to the sling or ER brace. The results of this study will provide the best evidence for choosing emergent immobilization for shoulder dislocations.
- Conditions
- Primary Anterior Shoulder Dislocation
- Being tested
- Sling, External Rotation Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SlingDevice
External Rotation BraceDevice
| Study group | Role | What they receive |
|---|---|---|
| External Rotation Brace | Experimental | Shoulder placed in an external rotation brace for 4 weeks Receives: Device: External Rotation Brace |
| Traditional Sling | Active comparator | Patient placed in traditional sling Receives: Device: Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-dislocation of shoulder
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study start1 Feb 2013
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Why it stopped: Slow patient enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Anterior Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197819
- Sponsor's protocol ID
- EERAADS
- Acronym
- EERAADS
- Status last verified
- Apr 2018
- First submitted
- 21 Jul 2014
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
- ClinicalTrials.gov ID
- NCT02197819
- Acronym / sponsor ID
- EERAADS / EERAADS
- Conditions
- Primary Anterior Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patient enrolment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 23 Jul 2014 (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.
Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2% in the general population. In young patients, recurrence after a primary dislocation is also common (~60%) and multiple recurrent episodes can cause significant disability over time. Following initial reduction of the joint, the traditional treatment for primary shoulder dislocations has been immobilization in a sling, with the arm in a position of adduction and internal rotation. The length of the immobilization period is controversial, however most authors would recommend between three to six weeks in a sling followed by several months of rehabilitation to include range of motion and strengthening exercises. The clinical course of patients after this approach has been extensively investigated. Of particular interest is the relatively high rate of recurrent instability in young patients, reported to be between 17 and 96%.
A prospective randomized trial is needed to determine whether in young patients (16-30 yrs of age) following reduction of a first-time traumatic anterior shoulder dislocation, does EMERGENT (<4 hours post reduction) immobilization of the affected shoulder in external rotation reduce the rate of recurrent instability experienced within 12 months versus emergent immobilization in a traditional internal rotation sling? Eligible patients will be randomly allocated to the sling or ER brace. The results of this study will provide the best evidence for choosing emergent immobilization for shoulder dislocations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Rotation Brace | Experimental | Device: External Rotation BraceShoulder placed in an external rotation brace for 4 weeks |
| Traditional Sling | Active comparator | Device: SlingPatient placed in traditional sling |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Skeletally mature patients between 18 - 35 years of age inclusive
- Patient is seen within 24 hours from time of injury.
- Sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by;
- Mechanism of abduction, external rotation
- Sudden pain in the shoulder
Key exclusion criteria (8 listed)
- Incompetent or unwilling to consent
- Inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments.
- Previous instability of the affected shoulder
- Significant associated fracture (Exception Hill Sachs or bankart lesions)
- Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
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 |
|---|---|---|
| Sling | Device | Traditional Sling |
| External Rotation Brace | Device | External Rotation Brace |
Primary outcome
Re-dislocation of shoulder
Time frame: within 12 months
Results and safety
The study was stopped early (reason given: Slow patient enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
Related trials for Primary Anterior Shoulder Dislocation
Not yet recruitingObservational study
Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sling and External Rotation Brace in people with Primary Anterior Shoulder Dislocation, run by Unity Health Toronto at 1 site in Canada.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Slow patient enrolment). 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?
Re-dislocation of shoulder (time frame: within 12 months). 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 4 Apr 2019.