Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

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

Study Overview

• Status: Unknown
• Conditions: Bone Fracture
• Intervention / Treatment: Device: Woodcast; Device: Traditional Cast

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • Recruiting
    • Clinical Research Facility, Sheffield Childrens Hospital
    • Contact: Dominic Nash; Phone Number: 01143053478; Email: dominic.nash@sch.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wood cast; Participants will be trialling the woodcast plaster method	Device: Woodcast; Application of a woodcast
Placebo Comparator: Traditional Cast; Traditional cast used to be compared to.	Device: Traditional Cast; Application of a traditional cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Woodcast effectiveness	Whether the cast needs to be changed during the course of the treatment.	3 months

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: SCH-2187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No