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Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

Primary Purpose

Ankle Sprain Strain

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
DJO Walker
Traditional plaster cast
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain Strain

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheffield Children's NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DJO Walker

Traditional plaster cast

Arm Description

Application of DJO Walker

Application of traditional plaster cast

Outcomes

Primary Outcome Measures

To compare the plaster cast intervention versus the DJO Walker intervention
Patient and Carer Treatment Evaluation Questionnaire

Secondary Outcome Measures

Full Information

First Posted
April 23, 2015
Last Updated
July 8, 2020
Sponsor
Sheffield Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04230538
Brief Title
Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2013 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain Strain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DJO Walker
Arm Type
Experimental
Arm Description
Application of DJO Walker
Arm Title
Traditional plaster cast
Arm Type
Active Comparator
Arm Description
Application of traditional plaster cast
Intervention Type
Device
Intervention Name(s)
DJO Walker
Intervention Type
Device
Intervention Name(s)
Traditional plaster cast
Primary Outcome Measure Information:
Title
To compare the plaster cast intervention versus the DJO Walker intervention
Description
Patient and Carer Treatment Evaluation Questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6-16 years foot size has to be large enough for the smallest available DJO Walker 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) acute injuries (less than 72 hours old) 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 signed consent Exclusion Criteria: <6 and >16 foot size too small for DJO Walker any unstable ankle injury any ankle injury that could not be treated weightbearing in cast/aircast boot (pain permitting) patients/carers unwilling to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Flowers
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
State/Province
Sheffield (South Yorkshire District)
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

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Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

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