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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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint.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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DJO Walker | Experimental | Application of DJO Walker |
|
| Traditional plaster cast | Active Comparator | Application of traditional plaster cast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DJO Walker | Device |
| ||
| Traditional plaster cast |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the plaster cast intervention versus the DJO Walker intervention | Patient and Carer Treatment Evaluation Questionnaire | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Flowers | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Children's NHS Foundation Trust | Sheffield | Sheffield (South Yorkshire District) | S10 2TH | United Kingdom |
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