ANZCTR - Registration

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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

Condition category

Condition code

Injuries and Accidents

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]

Treatment: Devices

Comparator / control treatment

Control: a below knee ‘walking’ fibreglass backslab.

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

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]

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?

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]

Charities/Societies/Foundations

Name [1]

Australian Orthopedic Association

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Emergency Department, Royal Children's Hospital

Address

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Emergency Department, Royal Children's Hospital

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/03/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Lisa N. Sharwood, Research Coordinator

Address

Emergency Department
Royal Children's Hospital
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 93456160

Fax

lisa.sharwood@mcri.edu.au

Contact person for scientific queries

Name

Lisa N. Sharwood, Research Coordinator

Address

Emergency Department
Royal Children's Hospital
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 93456160

Fax

lisa.sharwood@mcri.edu.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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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