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.
1 other identifier
interventional
100
1 country
1
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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2013
CompletedFirst Submitted
Initial submission to the registry
April 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedJuly 10, 2020
July 1, 2020
6.1 years
April 23, 2015
July 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the plaster cast intervention versus the DJO Walker intervention
Patient and Carer Treatment Evaluation Questionnaire
3 months
Study Arms (2)
DJO Walker
EXPERIMENTALApplication of DJO Walker
Traditional plaster cast
ACTIVE COMPARATORApplication of traditional plaster cast
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \<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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Flowers
Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2015
First Posted
January 18, 2020
Study Start
March 12, 2013
Primary Completion
March 30, 2019
Study Completion
March 30, 2019
Last Updated
July 10, 2020
Record last verified: 2020-07