Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

Bone Fracture Clinical Trial

Official title:

RCT Comparing the Efficacy of POP Cast vs Woodcast for Distal Radial Fractures in Children.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247295
• Other study ID #: SCH-2187
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: January 2020
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone

Intervention

Device:
• Traditional Cast
Application of a traditional cast
• Woodcast
Application of a woodcast

Locations

Country	Name	City	State
United Kingdom	Clinical Research Facility, Sheffield Childrens Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale	Whether the woodcast is comfortable to the patient	3 months
Primary	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.	3 months
Primary	Woodcast effectiveness	Whether the cast needs to be changed during the course of the treatment.	3 months