Ankle Sprain StrainNCT04230538
Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries
A study testing DJO Walker and Traditional plaster cast in people with Ankle Sprain Strain, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 In the last decade in adult patients this has been superceded in many instances by the use of a removable foot brace/splint. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Ankle Sprain Strain
- What is being tested?
- DJO Walker and Traditional plaster cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2013to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-16 years
- foot size has to be large enough for the smallest available DJO Walker
- 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)
- acute injuries (less than 72 hours old)
- 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
- signed consent
Who cannot join
- <6 and >16
- foot size too small for DJO Walker
- any unstable ankle injury
- any ankle injury that could not be treated weightbearing in cast/aircast boot (pain permitting)
- patients/carers unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
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.
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.
Read the 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
- Being tested
- DJO Walker, Traditional plaster cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DJO WalkerDevice
Traditional plaster castDevice
| Study group | Role | What they receive |
|---|---|---|
| DJO Walker | Experimental | Application of DJO Walker Receives: Device: DJO Walker |
| Traditional plaster cast | Active comparator | Application of traditional plaster cast Receives: Device: Traditional plaster cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the plaster cast intervention versus the DJO Walker intervention
Patient and Carer Treatment Evaluation Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Mar 2013
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Sprain StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Flowers, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230538
- Sponsor's protocol ID
- SCH/12/070
- Status last verified
- Jul 2020
- First submitted
- 23 Apr 2015
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04230538
- Acronym / sponsor ID
- SCH/12/070
- Conditions
- Ankle Sprain Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 Mar 2013 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DJO Walker | Experimental | Device: DJO WalkerApplication of DJO Walker |
| Traditional plaster cast | Active comparator | Device: Traditional plaster castApplication of traditional plaster cast |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 6-16 years
- foot size has to be large enough for the smallest available DJO Walker
- 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)
- acute injuries (less than 72 hours old)
- 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
Key exclusion criteria (5 listed)
- <6 and >16
- foot size too small for DJO Walker
- any unstable ankle injury
- any ankle injury that could not be treated weightbearing in cast/aircast boot (pain permitting)
- patients/carers unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DJO Walker | Device | DJO Walker |
| Traditional plaster cast | Device | Traditional plaster cast |
Primary outcome
To compare the plaster cast intervention versus the DJO Walker intervention
Time frame: 3 months
Patient and Carer Treatment Evaluation Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Flowers principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DJO Walker and Traditional plaster cast in people with Ankle Sprain Strain, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the plaster cast intervention versus the DJO Walker intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.