NCT04230538

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sheffield Children's NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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.

Conditions

• Ankle Sprain Strain

Interventions

Type	Name	Description
DEVICE	DJO Walker
DEVICE	Traditional plaster cast

Timeline

• Start date: 2013-03-12
• Primary completion: 2019-03-30
• Completion: 2019-03-30
• First posted: 2020-01-18
• Last updated: 2020-07-10

Locations

1 site across 1 country: United Kingdom