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Trial registered on ANZCTR


Trial ID
ACTRN12612000480886
Ethics application status
Not yet submitted
Date submitted
30/04/2012
Date registered
2/05/2012
Date last updated
2/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of treatment methods for undisplaced supracondylar humeral (elbow) fractures in children.
Scientific title
The effect of three different types of external immobilisation methods comparing pain during application and functional outcome for children with undisplaced supracondylar humeral fractures.
Secondary ID [1] 280423 0
Nil
Universal Trial Number (UTN)
U1111-1130-3360
Trial acronym
SUPE study (Study of undisplaced paediatric elbows)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute isolated Gartland Type 1 supracondylar humeral fracture confirmed on xray. 286390 0
Condition category
Condition code
Musculoskeletal 286640 286640 0 0
Other muscular and skeletal disorders
Injuries and Accidents 286648 286648 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare the effectiveness of different external immobilisation methods for the management of acute Gartland Type 1 supracondylar humeral fractures, patients will be randomly allocated to 1 of the following 3 treatment groups:
Group 1 (control group) will have collar and cuff sling under clothing with elbow flexion at 120 degrees
Group 2 (low sling) will have collar and cuff sling under clothing with elbow flexion at 90 degrees
Group 3 (backslab) will have a posterior plaster of Paris backslab and collar and cuff sling over clothing with elbow flexion at 50 degrees

The patients in all groups will wear the external immobilisation for a total of 3 weeks. Patients in group 1 and 2 will wear the sling day and night. Patients in group 3 will have the posterior backslab insitu for 3 weeks day and night and will wear the sling during the day - the sling may be removed at night when sleeping.
Intervention code [1] 284777 0
Treatment: Devices
Comparator / control treatment
Group 1 (as above) as this is our current practice in the department. The collar and cuff sling will be worn under clothing day and night for a total of 3 weeks.
Control group
Active

Outcomes
Primary outcome [1] 287042 0
To determine optimal treatment of acute isolated Gartland Type 1 supracondylar humeral fractures in children with regard to pain during application of external immobilisation. Pain will be measured using the Faces Pain Scale-Revised and the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale will be used for children who are unable to self report.
Timepoint [1] 287042 0
At time of application of external immobilsation in the Emergency Department.
Secondary outcome [1] 297260 0
Our secondary aim is to determine the functional outcome for each intervention. The Activities Scale for Kids will be used to measure this.
Timepoint [1] 297260 0
At subsequent Fracture Clinic visits at 1, 3 and 7 weeks after discharge from the Emergency Department.

Eligibility
Key inclusion criteria
Children presenting to PMH ED aged between 3 and less than 9 years diagnosed with an acute isolated Gartland Type 1 supracondylar humeral fracture confirmed on xray.
Minimum age
3 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children aged less than 3 years and 9 years or older
Supracondylar humeral fractures other than Gartland Type 1 and those which are not isolated fractures
Injury sustained more than 3 days ago (ie: not acute)
Neurovascular compromise
Open fractures
Multiple trauma patients
Head injury resulting in impaired judgement
No parent or legal guardian present who can give informed written consent

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)
Patients will be randomly allocated to one of three treatment groups. Computer generated block randomisation will be used and allocation concealed by sealed opaque envelopes which will be stored in the ED research office.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using computer generated block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285178 0
Hospital
Name [1] 285178 0
Princess Margaret Hospital for Children
Address [1] 285178 0
GPO Box D184 Perth Western Australia 6840
Country [1] 285178 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
GPO Box D184 Perth, Western Australia, 6840
Country
Australia
Secondary sponsor category [1] 284046 0
None
Name [1] 284046 0
Address [1] 284046 0
Country [1] 284046 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287185 0
Child and Adolescent Health Service Ethics Committee
Ethics committee address [1] 287185 0
GPO Box D184
Perth
Western Australia
6840
Ethics committee country [1] 287185 0
Australia
Date submitted for ethics approval [1] 287185 0
07/06/2012
Approval date [1] 287185 0
Ethics approval number [1] 287185 0

Summary
Brief summary
The aim of this study is to determine the optimal treatment for uncomplicated elbow fractures (undisplaced supracondylar humeral fractures) in children by comparing three treatment methods. A supracondylar humeral fracture is a fracture or break to the bone immediately above the elbow. Children identified with an undisplaced supracondylar fracture will be randomly allocated to one of three treatment groups which will involve different methods of external immobilisation. Pain during application of these various methods and functional outcome will be measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34124 0
Address 34124 0
Country 34124 0
Phone 34124 0
Fax 34124 0
Email 34124 0
Contact person for public queries
Name 17371 0
Jemma Bates-Smith
Address 17371 0
GPO Box D184
Perth
Western Australia
6840
Country 17371 0
Australia
Phone 17371 0
+61, 08, 9340 8222
Fax 17371 0
Email 17371 0
Jemma.Bates-Smith@health.wa.gov.au
Contact person for scientific queries
Name 8299 0
Jemma Bates-Smith
Address 8299 0
GPO Box D184
Perth
Western Australia
6840
Country 8299 0
Australia
Phone 8299 0
+61, 08, 9340 8222
Fax 8299 0
Email 8299 0
Jemma.Bates-Smith@health.wa.gov.au