Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

A Prospective Randomised Control Study in 6-16 Year Old Children Presenting to Sheffield Children's NHSFT With Stable Ankle Injuries That Would Otherwise Have Received Cast Immobilisation.

Present treatment of children with stable ankle and foot injuries very often involves a period in plaster cast(s). In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.

There are many benefits to this approach including progressive rehabilitation, reduced costs in materials and personnel, improved hygiene and adaptability of fit. The use of such a splint has not been investigated in children and this project aims to assess the value of introducing this as a treatment mode through the analysis of outcomes between traditional cast treatment and the newer removable brace/splint treatment. The outcomes will include patients' preferences, clinical results and relative costings.

Study Overview

• Status: Completed
• Conditions: Ankle Sprain Strain
• Intervention / Treatment: Device: DJO Walker; Device: Traditional plaster cast

Detailed Description

The study is a longitudinal cohort study of all eligible ankle injuries per the eligibility criteria presenting to Sheffield Children's NHS Fountain Trust. These children and their parents/carers are presented with an information sheet regarding the study and are then invited to enter the study.

Once consented - by appropriately trained research and/or clinical staff - those recruited are treated in either cast or boot on the basis of block randomisation.

Patients are followed up per protocol and outcomes completed by patients and clinicians.

Study information is kept securely for future analysis and write up.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield (South Yorkshire District)
    • Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
      • Sheffield Children's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 6-16 years
2. foot size has to be large enough for the smallest available DJO Walker
3. presentation to the Sheffield Children's Hospital Emergency Department or Fracture Clinic (some patients present directly to the fracture clinic if they have been injured elsewhere (eg. on holiday or in competitions)
4. acute injuries (less than 72 hours old)
5. stable ankle injuries. This is all ankle sprains and all stable undisplaced ankle fractures. The key here is that the patient would be able to weightbear in cast/DJO Walker without detriment to the ankle injury, pain permitting
6. signed consent

Exclusion Criteria:

1. <6 and >16
2. foot size too small for DJO Walker
3. any unstable ankle injury
4. any ankle injury that could not be treated weightbearing in cast/aircast boot (pain permitting)
5. patients/carers unwilling to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DJO Walker; Application of DJO Walker	Device: DJO Walker
Active Comparator: Traditional plaster cast; Application of traditional plaster cast	Device: Traditional plaster cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the plaster cast intervention versus the DJO Walker intervention	Patient and Carer Treatment Evaluation Questionnaire	3 months

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Investigators: Principal Investigator: Mark Flowers, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2013
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: SCH/12/070