Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

Sponsor

Sheffield Children's NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT04247295

Collaborator

(none)

Enrollment

Location

Arms

28.7

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bone Fracture	Device: Traditional Cast Device: Woodcast	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 7, 2017

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Apr 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale [3 months]
Whether the woodcast is comfortable to the patient
Woodcast effectiveness versus traditional cast [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 [3 months]
Whether the cast needs to be changed during the course of the treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Facility, Sheffield Childrens Hospital	Sheffield		United Kingdom

Sponsors and Collaborators

Sheffield Children's NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheffield Children's NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04247295

Other Study ID Numbers:

SCH-2187

First Posted:

Jan 30, 2020

Last Update Posted:

Jan 31, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Jan 31, 2020