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Trial registered on ANZCTR


Registration number
ACTRN12607000252415
Ethics application status
Approved
Date submitted
20/04/2007
Date registered
10/05/2007
Date last updated
21/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial Comparing Outcomes between 2 Treatments for Childhood Low Risk Ankle Fractures.
Scientific title
Functional Outcome after Air-Stirrup Ankle Brace or Fibreglass Walking Backslab for Paediatric Low Risk Ankle Fractures: A Randomised Observer-Blind Controlled Trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low risk ankle (fibular) fractures in children 1791 0
Condition category
Condition code
Injuries and Accidents 1877 1877 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to one of 2 groups, receiving either:
1.an Air-Stirrup ankle brace or
2. Control
Regardless of treatment, all participants are requested to wear their device for a period of 2 weeks. Following review at 2 weeks, those unable to weight-bear will be told to retain immobilisation device for a further week.
Intervention code [1] 1715 0
Treatment: Devices
Comparator / control treatment
Control: a below knee ‘walking’ fibreglass backslab.
Control group
Active

Outcomes
Primary outcome [1] 2666 0
Activity level at four weeks post injury using the performance measure of the Activities Scale for Kids (ASKp) which is a validated tool giving assessment of a child's physical functioning.
Timepoint [1] 2666 0
The ASKp will be completed by parents at baseline, referring to their child's activity level pre-injury (ie the week before for eg), then completed at 4 wks, allowing comparison to baseline.
Secondary outcome [1] 4525 0
At the four week follow up visit secondary outcome measures (as tested by the research physiotherapist) will include:
-strength, weight bearing and single leg standing
-proprioception
-range of motion using goniometry
-return to baseline activities as reported by parents
-patient preferences for one immobilization device versus the other
Timepoint [1] 4525 0
Secondary outcome measures also obtained through the daily clinical diaries will be the degree of pain calculated on a daily basis and use of analgesia (type and frequency).

Eligibility
Key inclusion criteria
Children present to the Emergency Department (ED) at the Royal Children’s Hospital with an acute, symptomatic, isolated low-risk ankle fracture within 72 hours after injury. Definition of low risk fractures includes the following: • undisplaced distal fibular types I & II Salter-Harris fractures • avulsion fractures of the distal fibula, fibular epiphysis, or lateral talusSince undisplaced Salter-Harris type I fractures are not evident on radiographs and the accepted standard for diagnosis of this fracture is based on clinical findings, a presumptive diagnosis of this fracture will be made using the following pre-defined criteria: age < 12 years, an examination consistent with maximal tenderness and swelling over the distal fibular growth plate and a radiograph demonstrating the absence of bony fracture with evidence of soft tissue swelling over the open distal fibular growth plate.
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude from study participation: • children with pre-existing musculoskeletal disease or surgery• children with coagulopathies, or an anti-coagulant therapy• children with gross motor developmental delay• children with previous history of injury of the affected ankle within the three months prior to presentation• children with multi-system or multi-limb trauma, distal tibial, foot and/or open fractures

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)
Parents or participants will provide informed consent. Allocation to treatment will be randomised. Allocation will be concealed, as the sealed opaque envelopes containing randomisation numbers will be externally prepared and randomly sequenced by computor generation in the Clinical Epidemiology and Biostatistics Unit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation numbers will be computor generated and managed by the Clinical Epidemiology and Biostatics Dept. of the hospital. Patients will be randomised in blocks to one of 2 groups and stratified by age. Age stratification will use two groups – ages 5-10 years, and 10-15 years.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants (subjects) will not be blinded to their treatment allocation as they will see what type of immobilisation device they are wearing. When returning to the Emergency Department for their 2 and 4 week review they will be met by the Research Nurse who will remove their immobilisation device prior to them having their review appointments with both the Dr and Physiotherapist. Participants and their parents will have been instructed not to reveal which device they/their child had been wearing. Thus the assessing doctors and physiotherapists will be blinded. The data analsyis will have the raw data at trial completion which will reveal the treatment allocation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2024 0
Charities/Societies/Foundations
Name [1] 2024 0
Australian Orthopedic Association
Country [1] 2024 0
Australia
Primary sponsor type
Hospital
Name
Emergency Department, Royal Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 1834 0
Hospital
Name [1] 1834 0
Emergency Department, Royal Children's Hospital
Address [1] 1834 0
Country [1] 1834 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3754 0
Royal Children's Hospital
Ethics committee address [1] 3754 0
Ethics committee country [1] 3754 0
Australia
Date submitted for ethics approval [1] 3754 0
Approval date [1] 3754 0
28/03/2007
Ethics approval number [1] 3754 0
27039

Summary
Brief summary
Ankle injuries are very common among children. They include sprains and fractures such as isolated distal fibular fractures, which are the most common fractures of the lower extremity. They are a significant work load on an emergency department. Treatment has historically been based on the principle of treating these fractures by immobilisation; the affected limb being placed in a plaster cast for 3-6 weeks. Plaster cast immobilisation has been considered necessary due to fear of permanent damage, and to control pain. However, it has been shown that fibular fractures of this type are stable and at negligible risk for premature closure of the growth plate.

Previous studies have shown that immobilisation of patients with these type of injuries delays the return to normal activity; indeed supporting mobilisation to be beneficial in the healing process for these types of injuries. In the treatment of ankle sprains, mobilisation has likewise been shown to improve outcome and return patients more rapidly to full activity than does plaster cast immobilisation. One study compared the air-stirrup ankle brace with a full plaster, and showed a better functional activity level at 4 weeks post injury with the ankle brace. However, with the current availability of strong fibreglass splints which allow ambulation (unlike plaster), these have become standard treatment of choice in many of these patients.

We aim to compare the air-stirrup ankle brace with the fibreglass ‘walking’ backslab splint, with a greater emphasis on mobilisation and physiotherapy. Participants will be randomised to receive either therapy, and be reviewed by a qualified physiotherapist at 2 and 4 weeks post injury. They will be given tailored exercises at 2 weeks.
A questionnaire called the Activities Scale for Kids (ASK) is a validated study tool that measures the degree of functional activity performed by a child (performance arm only). This will be filled out by the participating child’s parents at study enrolment, and then again at 4 weeks post injury. The primary outcome of the study is to compare the mean ASK score between both treatments at 4 weeks.
Secondary outcomes are to determine which treatment gives the quickest return to the mean baseline ASK score, which treatment is associated with the least pain (measured daily in the clinical diary), and which treatment is most preferred by parents and children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27818 0
Address 27818 0
Country 27818 0
Phone 27818 0
Fax 27818 0
Email 27818 0
Contact person for public queries
Name 10904 0
Lisa N. Sharwood, Research Coordinator
Address 10904 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 10904 0
Australia
Phone 10904 0
+61 3 93456160
Fax 10904 0
Email 10904 0
[email protected]
Contact person for scientific queries
Name 1832 0
Lisa N. Sharwood, Research Coordinator
Address 1832 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 1832 0
Australia
Phone 1832 0
+61 3 93456160
Fax 1832 0
Email 1832 0
[email protected]

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No Supporting Document Provided



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