Randomised Controlled Trial Comparing Outcomes between 2 Treatments for Childhood Low Risk Ankle Fractures.

• Conditions: ow risk ankle (fibular) fractures in children; Low risk ankle (fibular) fractures in children; Injuries and Accidents - Fractures

• Registration Number: ACTRN12607000252415
• Lead Sponsor: Emergency Department, Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 140

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. [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 Measures

Name	Time	Method
At the four week follow up visit secondary outcome measures (as tested by the research physiotherapist) will include: <br>-strength, weight bearing and single leg standing<br>-proprioception<br>-range of motion using goniometry<br>-return to baseline activities as reported by parents<br>-patient preferences for one immobilization device versus the other[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).]