Bone FractureNCT04247295
Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture
A study testing Traditional Cast and Woodcast in people with Bone Fracture, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators project is a randomised controlled trial that will compare the efficacy of the traditional casting method against the woodcast splint in distal radial fracture. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Traditional Cast and Woodcast
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2017to 30 Apr 2020
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 3 and 16 that present with a distal radial fracture.
Who cannot join
- Patients with underlying physical and learning disabilities.
- Patients with significant co-morbidities that would put the patient at risk of extra distress.
- Pathological fractures for instance Osteogenesis Imperfecta, metabolic bone diseases etc...
- Patients who aren't fluent in English as we only have questionnaires available in English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Research Facility, Sheffield Childrens Hospital
Sheffield
Dominic Nash, 01143053478, dominic.nash@sch.nhs.uk
About this study
Official title: RCT Comparing the Efficacy of POP Cast vs Woodcast for Distal Radial Fractures in Children.
The investigators project is a randomised controlled trial that will compare the efficacy of the traditional casting method against the woodcast splint in distal radial fracture. After the investigators have taken consent and the patients have agreed to be a part of the project, the investigators will randomly divide the participants into two groups. One with the traditional cast and one with the wood cast. The difference will be measured by using the EQ-5D-Y tool alongside the use of the DASH score and our own questionnaire.
The study will take place over the following year with the Sheffield Children's Hospital being the only site involved. Woodcast products have the CE declaration of conformity which is covered for the use in children, and apart from the type of cast the child is given, the course of treatment is the same for both group
Read the detailed description
Distal radial fractures are a very common fracture. Without good plaster immobilisation these fractures are prone to slipping. As a result, patients may end up with surgical treatment which would otherwise not be needed if the plaster were to hold the fracture position adequately. If one was shown to be better compared to the other, then all hospitals could start to use a more effective treatment.
With traditional casting, some of the details of the fracture are missed due to the shadowing on the x-ray. The woodcast aims to reduce this shadowing, allowing a more detailed image of the fracture and hopefully a better outcome. Problems may arise with the plaster cast, at one or two week scans, in which the cast may need to be removed for imaging, this could lead to displacement of the fracture effecting the outcome. Woodcast would potentially not need to be removed or is easily removed due to the fact that it is not a complete cast and so would hopefully improve the outcomes for the patient.
- Conditions
- Bone Fracture
- Being tested
- Traditional Cast, Woodcast
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional CastDevice
Application of a traditional cast
WoodcastDevice
Application of a woodcast
| Study group | Role | What they receive |
|---|---|---|
| Wood cast | Experimental | Participants will be trialling the woodcast plaster method Receives: Device: Woodcast |
| Traditional Cast | Placebo comparator | Traditional cast used to be compared to. Receives: Device: Traditional Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale
Whether the woodcast is comfortable to the patient
Measured: 3 months
Woodcast effectiveness versus traditional cast
To measure the displacement of the fracture seen on the x-ray, comparing those in the traditional cast and those in the Woodcast.
Measured: 3 months
Woodcast effectiveness
Whether the cast needs to be changed during the course of the treatment.
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 posted30 Jan 2020
- Study start7 Dec 2017
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies 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
- Model description
- 2 arms of randomised treatment methods, each participant will be either assigned to the traditional cast or the woodcast assigned.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247295
- Sponsor's protocol ID
- SCH-2187
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Comparing the Efficacy of POP Cast vs Woodcast for Distal Radial Fractures in Children.
- ClinicalTrials.gov ID
- NCT04247295
- Acronym / sponsor ID
- SCH-2187
- Conditions
- Bone Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 30 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.
The investigators project is a randomised controlled trial that will compare the efficacy of the traditional casting method against the woodcast splint in distal radial fracture. After the investigators have taken consent and the patients have agreed to be a part of the project, the investigators will randomly divide the participants into two groups. One with the traditional cast and one with the wood cast. The difference will be measured by using the EQ-5D-Y tool alongside the use of the DASH score and our own questionnaire.
The study will take place over the following year with the Sheffield Children's Hospital being the only site involved. Woodcast products have the CE declaration of conformity which is covered for the use in children, and apart from the type of cast the child is given, the course of treatment is the same for both group
Detailed description
Distal radial fractures are a very common fracture. Without good plaster immobilisation these fractures are prone to slipping. As a result, patients may end up with surgical treatment which would otherwise not be needed if the plaster were to hold the fracture position adequately. If one was shown to be better compared to the other, then all hospitals could start to use a more effective treatment.
With traditional casting, some of the details of the fracture are missed due to the shadowing on the x-ray. The woodcast aims to reduce this shadowing, allowing a more detailed image of the fracture and hopefully a better outcome. Problems may arise with the plaster cast, at one or two week scans, in which the cast may need to be removed for imaging, this could lead to displacement of the fracture effecting the outcome. Woodcast would potentially not need to be removed or is easily removed due to the fact that it is not a complete cast and so would hopefully improve the outcomes for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 arms of randomised treatment methods, each participant will be either assigned to the traditional cast or the woodcast assigned.
| Arm | Type | Receives |
|---|---|---|
| Wood cast | Experimental | Device: WoodcastParticipants will be trialling the woodcast plaster method |
| Traditional Cast | Placebo comparator | Device: Traditional CastTraditional cast used to be compared to. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 3 and 16 that present with a distal radial fracture.
Key exclusion criteria (4 listed)
- Patients with underlying physical and learning disabilities.
- Patients with significant co-morbidities that would put the patient at risk of extra distress.
- Pathological fractures for instance Osteogenesis Imperfecta, metabolic bone diseases etc...
- Patients who aren't fluent in English as we only have questionnaires available in English.
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 |
|---|---|---|
| Traditional CastApplication of a traditional cast | Device | Traditional Cast |
| WoodcastApplication of a woodcast | Device | Wood cast |
Primary outcome
Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale
Time frame: 3 months
Whether the woodcast is comfortable to the patient
Woodcast effectiveness versus traditional cast
Time frame: 3 months
To measure the displacement of the fracture seen on the x-ray, comparing those in the traditional cast and those in the Woodcast.
Woodcast effectiveness
Time frame: 3 months
Whether the cast needs to be changed during the course of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Clinical Research Facility, Sheffield Childrens Hospital
Sheffield, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Cast and Woodcast in people with Bone Fracture, 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale (time frame: 3 months). The study lists 3 primary outcomes in all. 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 31 Jan 2020.