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Search / Trial NCT04230538

Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

Launched by SHEFFIELD CHILDREN'S NHS FOUNDATION TRUST · Jan 14, 2020

Trial Information

Current as of May 14, 2025

Completed

Keywords

ClinConnect Summary

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...

Gender

ALL

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

About Sheffield Children's Nhs Foundation Trust

Sheffield Children's NHS Foundation Trust is a leading pediatric healthcare institution in the UK, dedicated to providing exceptional clinical care and advancing medical research for children. With a strong commitment to improving health outcomes, the Trust conducts innovative clinical trials that aim to enhance treatment options and care practices for pediatric patients. By collaborating with a multidisciplinary team of healthcare professionals and researchers, Sheffield Children's NHS Foundation Trust is at the forefront of child health research, contributing valuable insights to the global medical community while ensuring the highest standards of safety and ethics in all clinical trials.

Locations

Sheffield, Sheffield (South Yorkshire District), United Kingdom

Patients applied

0 patients applied

Trial Officials

Mark Flowers

Principal Investigator

Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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