Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

NCT04247295 | Unknown

• 1 other identifier: SCH-2187
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Bone Fracture

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Traditional Cast DEVICE

Application of a traditional cast

Traditional Cast

Woodcast DEVICE

Application of a woodcast

Wood cast

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 3 and 16 that present with a distal radial fracture.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Clinical Research Facility, Sheffield Childrens Hospital

Sheffield, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 30, 2020
• Study Start: December 7, 2017
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)