Clinical trial NCT04230538: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprain Strain
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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

Eligibility criteria: 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

Primary outcomes:
measure: To compare the plaster cast intervention versus the DJO Walker intervention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
state: Sheffield (South Yorkshire District)
Study officials:
affiliation: Investigator
name: Mark Flowers
role: PRINCIPAL_INVESTIGATOR
References: