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.|
|ClinicalTrials.gov Identifier: NCT04230538|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: DJO Walker
Application of DJO Walker
Device: DJO Walker
Active Comparator: Traditional plaster cast
Application of traditional plaster cast
Device: Traditional plaster cast
- To compare the plaster cast intervention versus the DJO Walker intervention [ Time Frame: 24 months ]Patient and Carer Treatment Evaluation Questionnaire
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 ClinicalTrials.gov identifier (NCT number): NCT04230538
|Contact: Paul Dimitriemail@example.com|
|Contact: Gillian Gatenbyfirstname.lastname@example.org|
|Sheffield Children's NHS Foundation Trust||Recruiting|
|Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH|
|Contact: Paul Dimitri email@example.com|
|Contact: Gillian Gatenby firstname.lastname@example.org|
|Principal Investigator: Mark Flowers|
|Principal Investigator:||Mark Flowers||Investigator|