search
Back to results

Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

Primary Purpose

Bone Fracture

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Traditional Cast
Woodcast
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Fracture

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Facility, Sheffield Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wood cast

Traditional Cast

Arm Description

Participants will be trialling the woodcast plaster method

Traditional cast used to be compared to.

Outcomes

Primary Outcome Measures

Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale
Whether the woodcast is comfortable to the patient
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.
Woodcast effectiveness
Whether the cast needs to be changed during the course of the treatment.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2020
Last Updated
January 29, 2020
Sponsor
Sheffield Children's NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04247295
Brief Title
Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture
Official Title
RCT Comparing the Efficacy of POP Cast vs Woodcast for Distal Radial Fractures in Children.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arms of randomised treatment methods, each participant will be either assigned to the traditional cast or the woodcast assigned.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wood cast
Arm Type
Experimental
Arm Description
Participants will be trialling the woodcast plaster method
Arm Title
Traditional Cast
Arm Type
Placebo Comparator
Arm Description
Traditional cast used to be compared to.
Intervention Type
Device
Intervention Name(s)
Traditional Cast
Intervention Description
Application of a traditional cast
Intervention Type
Device
Intervention Name(s)
Woodcast
Intervention Description
Application of a woodcast
Primary Outcome Measure Information:
Title
Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale
Description
Whether the woodcast is comfortable to the patient
Time Frame
3 months
Title
Woodcast effectiveness versus traditional cast
Description
To measure the displacement of the fracture seen on the x-ray, comparing those in the traditional cast and those in the Woodcast.
Time Frame
3 months
Title
Woodcast effectiveness
Description
Whether the cast needs to be changed during the course of the treatment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Research Facility, Sheffield Childrens Hospital
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Nash
Phone
01143053478
Email
dominic.nash@sch.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

We'll reach out to this number within 24 hrs