Condition category
Musculoskeletal Diseases
Date applied
22/12/2016
Date assigned
16/02/2017
Last edited
09/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Wrist fractures are the most common fracture sustained by the adults. The majority of wrist fractures can be treated without surgery, usually by immobilising the wrist (holding it in place) with a cast. The most commonly used casts in the UK are products based on Plaster-of-Paris or fibre glass. Woodcast is an alternative product for use in casts. It is made from woodchips and aims to improve patient comfort whilst being more environmentally friendly that traditional materials used. The study will compare casting using the traditional fibre glass to those using Woodcast. In order to see if a large full-scale study looking at this is possible, a small study must first be done to see if it would be possible. The aim of this study is to look at how easy it is to recruit participants to a study comparing fibre glass and Woodcast casting in order to see if a full scale trial would be possible.

Who can participate?
Patients aged 16 years and over who have a broken wrist.

What does the study involve?
Initially, patients attend the accident and emergency department with their injury. If the patient has a broken wrist then a temporary plaster cast is applied and they are asked to attend an outpatient clinic appointment 24-72 hours later. At this appointment, patients who agree to take part have an x-ray taken of their wrist and answer some questions about how they were before the injury and their quality of life. Participants are then randomly allocated to one of two groups. Those in the first group have the standard (fibre glass) treatment and those in the second group have the Woodcast treatment. Two weeks later, participatns attend another clinic appointment where they have their cast changed (fibre glass) or remoulded (Woodcast) if required. They also complete questionnaires about their pain levels, comfort and satisfaction with their treatment. After five weeks, participants have their cast removed and undergo another X-ray to check the bones have repaired well. Finally, after three months, participants receive a questionnaire in the post to fill in and return. They are also asked about any complications they have encountered since leaving outpatients, such as if they have had to visit their GP or a physiotherapist.

What are the possible benefits and risks of participating?
There are no direct benefits to the participant for taking part in the trial however the information from this study may help to improve treatment for future patients with similar injuries. It will also provide valuable information on best use of resources within the NHS. The treatments that all participants will receive in this study are already available in the UK and so there are very few risks associated with the study, such as the risk of bones moving beneath the cast or from low dose of ionising radiation during x-rays.

Where is the study run from?
1. Oxford University Hospital (UK)
2. Walsgrave General Hospital (UK)

When is the study starting and how long is it expected to run for?
December 2016 to September 2018

Who is funding the study?
Onbone Oy (UK)

Who is the main contact?
Mr Stephen Gwilym
steve.gwilym@ndorms.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stephen Gwilym

ORCID ID

http://orcid.org/0000-0002-1323-8646

Contact details

Oxford Trauma Unit
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 7554 669554
steve.gwilym@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.0

Study information

Scientific title

Woodcast vs Standard casting material for the immobilisation of wrist fractures treated non-operatively – A randomised feasibility trial to see if patients agree to be randomised and accept the cast allocated

Acronym

WOODCAST

Study hypothesis

Research question:
It is feasible to recruit a fully randomised trial comparing Woodcast splints against conventional casting methods?

Hypotheses:
1. Woodcast splinting will not result in higher rates of fracture displacement compared against conventional casting methods within the feasibility study population (clinical efficacy)
2. There will be no difference in the patient reported experience of their period of immobilisation, between the two casting methods within the feasibility study population (patient satisfaction)
3. There will be no difference in the distribution of patient-reported functional outcome and quality of life measures between the two casting methods within the feasibility study population (patient outcome)
4. There will be no difference in the rate, or form of, complications experienced by the subjects exposed to the two casting methods within the feasibility study population (patient safety)

Ethics approval

East Midlands Leicester South REC, 27/03/2017, ref: 17/EM/0103

Study design

Multi-centre randomised parallel feasibility study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Fractured distal radius (broken wrist)

Intervention

Initially, patients attend the accident and emergency department with their injury. If the patient has fractured their distal radius (broken their wrist) they have a temporary plaster cast applied at the department and then need to attend an outpatient clinic 24-72 hours later. At this first outpatient review routine X-rays are taken and the participant is asked about their pre-injury status. They are then asked to fill out a Patient Rated Wrist Evaluation (PRWE) and an EQ-5D-5L questionnaire.

Participants are then randomised to one of two groups via the use of a centralised computer randomisation service RRAMP (https://rramp.octru.ox.ac.uk) provided by the Oxford Clinical Trials Research Unit (OCTRU). Randomisation will be stratified by age and whether or not the wrist was initially manipulated in the emergency department, using a variable block size to ensure the participants from each study site have an equal chance of receiving each intervention.

Group 1: Participants have the Standard (fibre glass) treatment applied as per local hospital procedures.

Group 2: Participants have the Woodcast treatment applied as per local hospital procedures.

At 2 weeks(+/-5 days) post randomisation participants attend the outpatients clinic again and if required, have their cast changed (fibre glass) or remoulded (Woodcast). Further questionnaires relating to the assessment of pain, comfort and satisfaction, and specifically the cast will be carried out.

At 5 weeks (+/-14 days) post randomisation the participant has their cast removed and another X-ray to check the bones have repaired well. They will also be asked the same questions as at their 2 week visit.

Finally, after 3 months (+/-3 weeks) post randomisation, the participants receive a PRWE and EQ-5D-5L questionnaire in the post to fill in and return. They are also asked about any complications they have encountered since leaving outpatients, such as if they have had to visit their GP or a physiotherapist.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Recruitment rate is determined from the number of eligible participants who consent to taking part in the study.

Secondary outcome measures

1. Wrist function is assessed using the Patient Rated Wrist Evaluation (PRWE) which is a validated questionnaire consisting of 15 items specifically related to the function of the wrist. It is measured at baseline and three months
2. Health related quality of life is assessed using the EQ-5D-5L which is a validated questionnaire relating to daily activities with a 5-level answer possibility, which will be converted into multi-attribute utility scores using an established algorithm at baseline and three months
3. Complication rate is assessed by patient review and the need for further follow up (physiotherapy etc) at three months
4. Radiographic evaluation: Standard posterior-anterior and lateral radiographs will be taken at baseline and at the routine follow-up appointment 5-weeks after the injury

Overall trial start date

12/12/2016

Overall trial end date

01/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sustained a fracture of the distal radius, which is defined as a fracture within or equal to 3 cm of the radio-carpal joint
2. Over the age of 16
3. Able to give informed consent
4. The treating outpatient clinician believes that they would not benefit from surgery in the form of further manipulation of the fracture under anaesthetic or the insertion of metalwork
5. The patient is required to have a change of cast at the initial outpatient review

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. The injury is more than one week old
2. The fracture extends more than 3 cm from radio carpal joint
3. The fracture is open
4. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as cognitive impairment
5. The patient sustained fractures to other areas of the body at the time they broke their wrist

Recruitment start date

19/06/2017

Recruitment end date

12/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospital
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Doncaster and Bassetlaw Teaching Hospitals,
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

Trial participating centre

Royal Berkshire Hospital
Craven Road
Reading
RG1 5AN
United Kingdom

Trial participating centre

Nottingham University Hospitals
Nottingham
NG7 2RD
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
University of Oxford
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
+44 1865 572245
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Onbone Oy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A scientific report, suitable for publication in a peer-reviewed journal, will be prepared by the trial management team at the completion of the trial.

IPD Sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/04/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/03/2018: The following changes were made: 1. Recruitment end date has been updated from 28/02/2018 to 12/03/2018. 2. Overall trial end date has been updated from 30/04/2018 to 01/09/2018. 26/01/2018: The recruitment end date has been updated from 30/09/2017 to 28/02/2018. Walsgrave General Hospital has been removed as a trial participating centre and Doncaster and Bassetlaw Teaching Hospitals, Royal Berkshire Hospital and Nottingham University Hopistals have been added. 19/06/2017: The recruitment start date has been updated from 06/06/2017 to 19/06/2017. In addition, the ethics approval information has been added. 19/05/2017: The recruitment start date has been updated from 01/06/2017 to 06/06/2017.