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Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

NCT ID: NCT04247295

Last Updated: 2020-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2020-04-30

Brief Summary

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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

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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

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Bone Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arms of randomised treatment methods, each participant will be either assigned to the traditional cast or the woodcast assigned.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Wood cast

Participants will be trialling the woodcast plaster method

Group Type EXPERIMENTAL

Woodcast

Intervention Type DEVICE

Application of a woodcast

Traditional Cast

Traditional cast used to be compared to.

Group Type PLACEBO_COMPARATOR

Traditional Cast

Intervention Type DEVICE

Application of a traditional cast

Interventions

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Traditional Cast

Application of a traditional cast

Intervention Type DEVICE

Woodcast

Application of a woodcast

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children between the ages of 3 and 16 that present with a distal radial fracture.

Exclusion Criteria

* 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Facility, Sheffield Childrens Hospital

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Dominic Nash

Role: primary

Other Identifiers

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SCH-2187

Identifier Type: -

Identifier Source: org_study_id