Shoulder DislocationPhase 2/3NCT00202735
Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
A Phase 2/3 study testing Arm1:Immobilization in external rotation and immobilization in internal rotation in people with Shoulder Dislocation, run by Sorlandet Hospital HF.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Arm1:Immobilization in external rotation and immobilization in internal rotation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Feb 2008
- Phase
- Phase 2/3
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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. -
About this study
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.
Read the detailed description
See earlier protocol in 2005
- Conditions
- Shoulder Dislocation
- Being tested
- Arm1:Immobilization in external rotation, immobilization in internal rotation
- Keywords
- shoulder dislocation, anterior, traumatic, primary, first time, initial, immobilization, external, rotation
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm1:Immobilization in external rotationProcedure or surgery
Also called Immobilization in external rotation.
Immobilization in external rotation (ER) All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling Er,15˚ version).To control the position,a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed in 15 degrees of external rotation.
immobilization in internal rotationProcedure or surgery
All the patients in the internal rotation(IR) group are immobilized with their arm/shoulder in internal rotation by using a normal collar and cuff device.
| Study group | Role | What they receive |
|---|---|---|
| Immobilization in internal rotation | Active comparator | Immobilization in internal rotation:All patients in this group are immobilized with the arm in internal rotation.
The arm is immobilized with a normal collar and cuff device. Receives: Procedure: immobilization in internal rotation |
| Immobilization in external rotation. | Experimental | Immobilization in external rotation (ER. All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling ER, 15˚ version.To control the position, a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed Receives: Procedure: Arm1:Immobilization in external rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reluxation
Measured: After 2 years
Secondary outcomes (2)
Function,WOSI score,SIQ score
Measured: Between second and third year after the primary dislocation.
Pain,Wosi score and SIQ score
Measured: Between the second and third year after the primary dislocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, Haukeland University Hospital, Sykehuset i Vestfold HF, Helse Stavanger HF, Sykehuset Telemark, Sykehuset Buskerud HF, Blefjell Hospital HF, Sykehuset Asker og Baerum, St. Olavs Hospital, University Hospital, Akershus
- Investigators
- Svein Svenningsen, M.D., Study chair, Sorlandet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202735
- Sponsor's protocol ID
- 811327
- Status last verified
- Jan 2005
- First submitted
- 9 Sep 2005
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
- ClinicalTrials.gov ID
- NCT00202735
- Acronym / sponsor ID
- 811327
- Conditions
- Shoulder Dislocation
- Keywords
- shoulder dislocation, anterior, traumatic, primary, first time, initial, immobilization, external
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital, Haukeland University Hospital, Sykehuset i Vestfold HF, Helse Stavanger HF, Sykehuset Telemark, Sykehuset Buskerud HF, Blefjell Hospital HF, Sykehuset Asker og Baerum, St. Olavs Hospital, University Hospital, Akershus
- Study start
- Jan 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Sep 2005 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immobilization in internal rotation | Active comparator | Procedure: immobilization in internal rotationImmobilization in internal rotation:All patients in this group are immobilized with the arm in internal rotation. The arm is immobilized with a normal collar and cuff device. |
| Immobilization in external rotation. | Experimental | Procedure: Arm1:Immobilization in external rotationImmobilization in external rotation (ER. All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling ER, 15˚ version.To control the position, a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (4 listed)
- 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. -
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 |
|---|---|---|
| Arm1:Immobilization in external rotationAlso: Immobilization in external rotation.Immobilization in external rotation (ER) All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling Er,15˚ version).To control the position,a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed in 15 degrees of external rotation. | Procedure or surgery | Immobilization in external rotation. |
| immobilization in internal rotationAll the patients in the internal rotation(IR) group are immobilized with their arm/shoulder in internal rotation by using a normal collar and cuff device. | Procedure or surgery | Immobilization in internal rotation |
Primary outcome
Reluxation
Time frame: After 2 years
2 secondary outcomes
Function,WOSI score,SIQ score
Time frame: Between second and third year after the primary dislocation.
Pain,Wosi score and SIQ score
Time frame: Between the second and third year after the primary dislocation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
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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.
Svein Svenningsen, M.D. study chair
Sorlandet Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arm1:Immobilization in external rotation and immobilization in internal rotation in people with Shoulder Dislocation, run by Sorlandet Hospital HF.
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 2 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: finished, as of the sponsor's last update on 8 May 2009. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reluxation (time frame: After 2 years). 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 8 May 2009.