Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000442808
Ethics application status
Approved
Date submitted
11/04/2012
Date registered
18/04/2012
Date last updated
18/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of conservative management with external rotation bracing versus arthroscopic surgical treatment for shoulder dislocation in young people
Scientific title
Modified conservative management with external rotation bracing versus early arthroscopic surgical intervention amongst 16 to 30 year olds with primary anterior shoulder dislocation: a randomised controlled trial to compare shoulder stability, clinical efficacy and quality of life
Secondary ID [1] 279987 0
Nil
Universal Trial Number (UTN)
U1111-1128-3196
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Shoulder Dislocations 285895 0
Condition category
Condition code
Musculoskeletal 286087 286087 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two interventions will be compared. Group A will receive external rotation bracing (using a Don Joy external Rotation Brace) full time for 6 weeks + routine post immobilization physical therapy. Group B will receive arthroscopic stabilisation surgery (approximately 90-180 minutes) + routine post operative physical therapy.
Intervention code [1] 284313 0
Treatment: Surgery
Intervention code [2] 284314 0
Treatment: Devices
Comparator / control treatment
Comparisons will be made between the Group A (External rotation brace) and Group B (arthroscopic stabilization surgery).
Control group
Active

Outcomes
Primary outcome [1] 286650 0
Western Ontario Shoulder Instability Index
Timepoint [1] 286650 0
baseline ,3months, 6 months, 1 year, 2 years
Secondary outcome [1] 296375 0
Patient Report or recorded medical history of recurrent dislocaton
Timepoint [1] 296375 0
baseline ,3months, 6 months, 1 year, 2 years
Secondary outcome [2] 296376 0
Health-related quality of life evaluated with the EQ-5D instrument.
Timepoint [2] 296376 0
baseline ,3months, 6 months, 1 year, 2 years
Secondary outcome [3] 296377 0
American Shoulder and Elbow Society Score (ASES)
Timepoint [3] 296377 0
baseline ,3months, 6 months, 1 year, 2 years
Secondary outcome [4] 296378 0
Diasabilities of the Arm, Shoulder and Hand (Quick Dash)
Timepoint [4] 296378 0
baseline ,3months, 6 months, 1 year, 2 years
Secondary outcome [5] 296379 0
Pain Visual Analogue Scale
Timepoint [5] 296379 0
baseline ,3months, 6 months, 1 year, 2 years
Secondary outcome [6] 296380 0
Patient Satisfaction Survey
Timepoint [6] 296380 0
baseline ,3months, 6 months, 1 year, 2 years
Secondary outcome [7] 296381 0
Compliance with intervention protocol (custom specific outcome developed by the research team).
Timepoint [7] 296381 0
baseline ,3months, 6 months, 1 year, 2 years

Eligibility
Key inclusion criteria
islolated shoulder injury with a typical history for anterior dislocaton
patient presenting within 7 days of injury
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of previous instability prior to index injury.
Significant acute associated fracture of scapula or humerus.
Significant acute ipsilateral no capsulo-labral soft tissue injury (cuff tear, vessel injury, nerve injury).
Previous surgery to ipsilateral shoulder.
Previous injury or condition in ipsilateral shoulder.
History of contralateral shoulder instability symptoms.
Associated significant injuries increasing risk of surgery or preventing compliance with bracing.
Medical/anaesthetic contraindication to surgery.
Unable to comply with rehabilitation or attend follow up appointments.
Currently pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified by clinical staff at participating hospital Emergency Departments. Patients meeting inclusion criteria who provide informed consent for participation in the study will be allocated the next participant identification number. The member of the research team coordinating intervention administration will then open an opaque envelope concealing the random allocation for that participant identification number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A member of the research team not involved in participant recruitment, assessments or intervention delivery will generate a random number sequence using a computerized random number generator. The randomization sequence will be concealed in opaque envelopes numbered in ascending order to correspond with participant identification numbers. Group allocation for each identification number will remain concealed in an opaque envelope until group allocation occurs.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5254 0
4102
Recruitment postcode(s) [2] 5256 0
4108
Recruitment postcode(s) [3] 5255 0
4163

Funding & Sponsors
Funding source category [1] 284845 0
Hospital
Name [1] 284845 0
Princess Alexandra Hospital
Country [1] 284845 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road
Wooloongabba Qld 4102
Brisbane
Country
Australia
Secondary sponsor category [1] 283932 0
Hospital
Name [1] 283932 0
Queen Elizabeth II Hospital
Address [1] 283932 0
Cnr Kessels and Troughton Road
Coopers Plains QLD 4108
Country [1] 283932 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286836 0
METRO SOUTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 286836 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba Qld 4102
Ethics committee country [1] 286836 0
Australia
Date submitted for ethics approval [1] 286836 0
17/11/2011
Approval date [1] 286836 0
21/02/2012
Ethics approval number [1] 286836 0
HREC/11/QPAH/643

Summary
Brief summary
The purpose of the study is to determine the clinical outcomes and effectiveness of two randomly allocated treatments used to manage acute anterior shoulder dislocations: six weeks of external rotation bracing versus early arthroscopic shoulder stabilisation intervention.

It is hypothesised that the arthroscopic shoulder stabilisation surgery may lead to better patient outcomes compared with the external rotation bracing on the basis that evidence for external rotation bracing is still emerging and (although promising) has not yet been established with as much rigor as arthroscopic shoulder stabilisation surgery. However, in the absence of substantial differences in patient outcomes, external rotation bracing may be demonstrated to be more cost-effective than surgery.

Outcomes from this study will inform clinical decision making about management for young people with shoulder dislocation. This study will not only impact clinical practice for this high demand patient group in Queensland, but nationally and internationally due to widespread uncertainty to the effectiveness (and cost-effectiveness) of the (cheaper and more conservative) external rotation bracing in comparison to arthroscopic shoulder stabilisation surgery amongst young patients (16-30 years) who have dislocated their shoulder for the first time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33806 0
Address 33806 0
Country 33806 0
Phone 33806 0
Fax 33806 0
Email 33806 0
Contact person for public queries
Name 17053 0
Andrew Johnson
Address 17053 0
Andrew Johnson
Physiotherapy
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba Qld 4102
Country 17053 0
Australia
Phone 17053 0
+61731763942
Fax 17053 0
+61731765759
Email 17053 0
andrew_johnson1@health.qld.gov.au
Contact person for scientific queries
Name 7981 0
Steven McPhail
Address 7981 0
Steven McPhail
Centre for Functioning and Health Research
Suite 304, Buranda Centro
Corner of Ipswich Road and Cornwall Street
Buranda Qld 4102
Country 7981 0
Australia
Phone 7981 0
+61734062266
Fax 7981 0
+61734062267
Email 7981 0
steven_mcphail@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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