Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

NCT ID: NCT04230538

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-12
• Study Completion Date: 2019-03-30

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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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

Conditions

Ankle Sprain Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DJO Walker

Application of DJO Walker

Group Type: EXPERIMENTAL

DJO Walker

Intervention Type: DEVICE

Traditional plaster cast

Application of traditional plaster cast

Group Type: ACTIVE_COMPARATOR

Traditional plaster cast

Intervention Type: DEVICE

Interventions

DJO Walker

Intervention Type: DEVICE

Traditional plaster cast

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Flowers

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), United Kingdom

Countries

United Kingdom

Other Identifiers

SCH/12/070

Identifier Type: -

Identifier Source: org_study_id