Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

Ankle Sprain Strain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230538
• Other study ID #: SCH/12/070
• Status: Completed
• Phase: N/A
• Start date: March 12, 2013
• Est. completion date: March 30, 2019

Study information

• Verified date: July 2020
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain Strain

Intervention

Device:
• DJO Walker

• Traditional plaster cast

Locations

Country	Name	City	State
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield	Sheffield (South Yorkshire District)

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the plaster cast intervention versus the DJO Walker intervention	Patient and Carer Treatment Evaluation Questionnaire	3 months