Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000047493
Ethics application status
Approved
Date submitted
10/01/2007
Date registered
12/01/2007
Date last updated
12/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A radomised controlled trial of two methods of immobilising supracondylar fractures of the humerus.
Scientific title
Is immobilisation with collar and cuff or backslab and sling associated with less pain and better parent satisfaction in children with minimally displaced supracondylar fractures of the humerus?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supracondylar fracture of the humerus 1540 0
Condition category
Condition code
Injuries and Accidents 1639 1639 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Immobilisation in a fiberglass back slab and sling

Immobilisation is for 2 weeks then reviewed. If necessary immobilisation for a further 2 weeks will be implemented. Patients are reviewed 2 weeks after mobilisation by phone.
Intervention code [1] 1548 0
Treatment: Other
Comparator / control treatment
Control group: Immobilisation in a collar and cuff type sling
Control group
Active

Outcomes
Primary outcome [1] 2260 0
Duration of pain
Timepoint [1] 2260 0
Collected at diagnosis, daily via a parent/patient diary, at 2 week review (and at 4 week review if needed)
Secondary outcome [1] 3937 0
Intensity of pain
Timepoint [1] 3937 0
Collected at diagnosis, daily via a parent/patient diary, at 2 week review ( and at 4 week review if needed).
Secondary outcome [2] 3938 0
parental satisfaction
Timepoint [2] 3938 0
Collected at diagnosis, daily via a parent/patient diary, at 2 week review ( and at 4 week review if needed).

Eligibility
Key inclusion criteria
Presenting to the Emergency Department of the Royal Children's hospital Melbourne And Undisplaced and minimally displaced supracondylar fractures of the distal upper arm.
Minimum age
18 Months
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other associated fractures of the same arm or more than 10 degrees of angulation of the distal segment (lower part) of the humeral fracture. Children with these conditions will be referred to the Orthopaedic Department as per normal practice.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2003
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)

Funding & Sponsors
Funding source category [1] 1784 0
Hospital
Name [1] 1784 0
Royal Children's Hospital
Country [1] 1784 0
Australia
Primary sponsor type
Individual
Name
Ed Oakley
Address
Country
Secondary sponsor category [1] 1591 0
None
Name [1] 1591 0
nil
Address [1] 1591 0
Country [1] 1591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3343 0
Royal Children's Hospital Melbourne
Ethics committee address [1] 3343 0
Ethics committee country [1] 3343 0
Australia
Date submitted for ethics approval [1] 3343 0
Approval date [1] 3343 0
05/07/2003
Ethics approval number [1] 3343 0
EHRC 23080 A

Summary
Brief summary
This is a prospective, randomised study to ascertain if plaster slab immobilisation of the arm is equally acceptable to parents and patients as collar and cuff immobilisation for undisplaced supracondylar fractures (breaks) of the upper arm near the elbow. All children aged 18 months to less than 11 years, presenting to the Emergency Department who sustain this type of break of the upper arm, will be enrolled into the study and randomised to receive one of two methods of immobilisation. Parents will be asked to keep a daily diary of analgesia use, child complaints or perceived problems with the mode of immobilisation. Followup will be 2 weeks post ED presentation, at which time the slab/collar will be removed and the supracondylar fracture xrayed and reassessed. At this time a parent/patient satisfaction questionnaire will be completed. If significant tenderness and discomfort remain the arm will be immobilised again and reviewed again in 2 weeks in ED.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27482 0
Address 27482 0
Country 27482 0
Phone 27482 0
Fax 27482 0
Email 27482 0
Contact person for public queries
Name 10737 0
Ed Oakley
Address 10737 0
Department of Emergency Medicine
RCH Flemington Rd Parkville Vic 3052
Country 10737 0
Australia
Phone 10737 0
03 9345 6592
Fax 10737 0
Email 10737 0
[email protected]
Contact person for scientific queries
Name 1665 0
Ed Oakley
Address 1665 0
Department of Emergency Medicine
RCH Flemington Rd Parkville Vic 3052
Country 1665 0
Australia
Phone 1665 0
03 9345 6592
Fax 1665 0
Email 1665 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.