Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT04247295
Status:
UNKNOWN
Last Update Posted:
2020-01-31
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture
Sponsor:
Sheffield Children's NHS Foundation Trust
Organization:
Study Overview
Official Title:
RCT Comparing the Efficacy of POP Cast vs Woodcast for Distal Radial Fractures in Children.
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: