The forearm fracture recovery in children evaluation study

Plain English Summary

Background and study aims
Torus (buckle) fractures of the wrist are the most common fractures in children. They result from injury to growing bones and account for 500,000 UK emergency attendances annually. Torus fractures have a very low risk of complications and universally heal well. There is considerable variation in the treatment of torus fractures, from the use of a removable rigid splint, to plaster cast immobilisation, to more flexible splints or soft bandages. The key differences are the degree of immobilisation provided and the follow-up required. Non-removable rigid casts are no longer recommended for the treatment of these injuries. Removable splints immobilise the wrist and may provide the best pain relief. Soft bandaging restricts movement the least and may encourage early function, but concern remains about pain and the potential for complications, despite evidence to the contrary. The National Institute for Health and Care Excellence (NICE) concluded that bandaging was probably the best treatment approach due to the convenience, adequate pain control and the ability to promote early function, though asked whether any treatment is really necessary. NICE also recommended that no follow-up of these injuries is necessary because they are almost always complication free and they universally heal well. However, there is variable follow-up at different hospitals. The aim of this study is to assess the effectiveness of the optional use of soft bandage and immediate discharge, compared to rigid splint immobilisation.

Who can participate?
Children aged 4 to 15 with a torus fracture of the wrist

What does the study involve?
Each participant is randomly allocated to either a soft bandage and immediate discharge, or rigid splint immobilisation and follow-up as per current practice at the treating centre. Participants are asked to record their pain and complete questionnaires to assess their ability to use their arm and their quality of life. This information is collected by a smartphone/email link to an electronic questionnaire at various intervals over a 6-week period.

What are the possible benefits and risks of participating?
The results may show the best way to treat these injuries in the future. The treatments involved in this study are of no additional risk to the participant.

Where is the study run from?
John Radcliffe Hospital (UK)
The study will be recruiting from a minimum of 15 centres treating children’s fractures across the UK

When is the study starting and how long is it expected to run for?
July 2018 to June 2020

Who is funding the study?
NIHR Health Technology Assessment Programme (UK)

Who is the main contact?
Mrs Louise Spoors
FORCE@ndorms.ox.ac.uk

Trial website

www.forcestudy.org

Type

Public

Primary contact

Mrs Louise Spoors

ORCID ID

Contact details

Kadoorie Centre
John Radcliffe Hospital
Oxford
OX39DU
United Kingdom
+44 (0)1865 228929
FORCE@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Mr Daniel Perry

ORCID ID

Contact details

Kadoorie Centre
John Radcliffe Hospital
Oxford
OX39DU
United Kingdom

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 17/23/02; Sponsor PID: 13849

Scientific title

A multi-centre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilisation for torus fractures of the distal radius in children

Acronym

FORCE

Study hypothesis

FORCE is an equivalence trial. The aim of this pragmatic RCT is to evaluate the clinical and cost-effectiveness of soft bandage immobilisation and immediate discharge, compared to rigid splint immobilisation and follow-up as per the protocol of the treating centre, for the treatment of torus fractures of the distal radius in children.

Ethics approval

Ref: 18/WM/0324 - approval pending

Study design

Multi-centre prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Currently not available in web format, please use contact details to request the participant information sheet.

Condition

Torus (buckle) fractures of the distal radius in children

Intervention

Each patient will be randomly allocated (1:1) with a randomisation sequence stratified by centre and age group (4-7 years and ≥8 years):
1. Soft bandage immobilisation and immediate discharge
2. Rigid splint immobilisation and follow-up as per the protocol of the treating centre

Participants are asked to record their pain and complete questionnaires to assess their ability to use their arm and their quality of life. This information will be collected via a smartphone/email link to an electronic questionnaire at various intervals over a 6 week period.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Pain measured using the Wong-Baker FACES Pain Rating Scale at three days post randomisation

Secondary outcome measures

1. Pain measured using the Wong-Baker FACES Pain Rating Scale at 1 day, 1, 3 and 6 weeks post randomisation
2. Use of regular analgesia assessed by questionnaire/survey via text at 1, 3 and 7 days post randomisation
3. Functional recovery measured using the Patient Report Outcomes Measurement System (PROMIS) Upper Extremity Limb Score for Children Computer Adaptive Test at 3 days, 1, 3 and 6 weeks post randomisation
4. Health-related quality of life measured using EQ-5DY at 3 days, 7 days, 3 and 6 weeks post randomisation
5. Number of days of school absence assessed by questionnaire/survey via text up to 3 and 6 weeks post randomisation
6. Complications, including the need for further hospital attendance, assessed by questionnaire/survey via text at 3 and 6 weeks post-randomisation
7. Resource use and comparative cost effectiveness assessed by questionnaire/survey via text at 3 and 6 weeks post randomisation

Overall trial start date

02/07/2018

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Radiographic evidence of a torus fracture of the distal radius whereby there is a cortical deformation within the distal third of the radius but no break in the cortex. These may be associated with an ipsilateral fracture to the ulna (the ulna fracture may be buckle, greenstick or otherwise)
2. Aged 4 to 15 years old inclusive
3. Randomisation must occur at the site able to definitively treat the injury (i.e. a centre able to take the decision regarding the definitive treatment approach, which will typically be the emergency department)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

696

Participant exclusion criteria

1. The injury is more than 36 hours old
2. The treating clinician judges that there is a cortical disruption of the radius on radiographs (i.e. a greenstick fracture)
3. They have sustained an additional fracture at the time of the index fracture (with the exception of ipsilateral ulna fractures)
4. There is evidence that the patient and/or parent/guardian would be unable to adhere to trial procedures or complete follow-up, such as insufficient English language comprehension, developmental delay or a developmental abnormality or no access by parents to a telephone

Recruitment start date

01/11/2018

Recruitment end date

31/12/2019

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Organisation

University of Oxford

Sponsor details

Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
United Kingdom

Sponsor type

University/education

Website

www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/force

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Publication and dissemination plan

The protocol will be available on the NIHR website.

Dissemination of the results will be via traditional and novel methods:
1. Conference: Traditional conference dissemination will focus on presentations to include the key professional stakeholders (emergency medicine doctors, orthopaedic surgeons, emergency nurse practitioners and trainees in emergency medicine and orthopaedics)
2. Publications: Key outputs will be published in high-impact journals with publicity sought in other professional journals (e.g. Pulse, HSJ, Nursing Times). The trialists will ensure that plain English summaries are published alongside the full paper, along with links to other digital media on the trial website to explain the trial result in an accessible format – i.e. an explainer video and infographic. Given the frequency of the injury, this is also likely to be of interest to international press outlets
3. Policy Makers: The trialists will ensure the development of links with key organisations such as NICE, NHS Information Centre, NHS England and Quality Observatories to contribute to and capitalise on their networks. Most importantly the outputs will directly contribute to the NICE non-complex fracture guidelines, and will be directly relevant to the widely publicised Choosing Widely Campaign
4. Public Dissemination: To ensure a broad campaign the trialists will target a range of social media outlets (e.g. twitter and blogs such as MumsNet) with the explainer video and infographic. They will seek to engage the NHS Dissemination centre, and seek to publish ‘digital story’ as part of the ‘NIHR Signal’. Finally, they will produce a Wikipedia page for this injury (currently absent) and update this with the trial result

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations