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Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04230538
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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

Condition or disease Intervention/treatment Phase
Ankle Sprain Strain Device: DJO Walker Device: Traditional plaster cast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 2013
Actual Primary Completion Date : March 5, 2019
Estimated Study Completion Date : May 5, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DJO Walker
Application of DJO Walker
Device: DJO Walker
Active Comparator: Traditional plaster cast
Application of traditional plaster cast
Device: Traditional plaster cast

Primary Outcome Measures :
  1. To compare the plaster cast intervention versus the DJO Walker intervention [ Time Frame: 24 months ]
    Patient and Carer Treatment Evaluation Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04230538

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Contact: Paul Dimitri
Contact: Gillian Gatenby

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United Kingdom
Sheffield Children's NHS Foundation Trust Recruiting
Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
Contact: Paul Dimitri   
Contact: Gillian Gatenby   
Principal Investigator: Mark Flowers         
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
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Principal Investigator: Mark Flowers Investigator

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Responsible Party: Sheffield Children's NHS Foundation Trust Identifier: NCT04230538    
Other Study ID Numbers: SCH/12/070
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Ankle Injuries
Wounds and Injuries
Leg Injuries
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action