Comparison of Woodcast vs Traditional Cast in Distal Radi... | NCT04247295

Studies
Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

NCT04247295

Sponsor

Sheffield Children's NHS Foundation Trust

Status

Unknown status

Last Update Posted

Jan 31, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Bone Fracture

Interventions

Traditional Cast
Woodcast

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 7, 2017Actual

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Apr 30, 2020Estimated

First Submitted Date

Jan 3, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2020

Last Update Posted Date

Jan 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Wood cast	Experimental	Participants will be trialling the woodcast plaster method	Device: Woodcast
Traditional Cast	Placebo Comparator	Traditional cast used to be compared to.	Device: Traditional Cast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Traditional Cast	Device	Application of a traditional cast	Traditional Cast

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Facility, Sheffield Childrens Hospital	Recruiting	Sheffield			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

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Browse Branches

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