The forearm fracture recovery in children evaluation study
| ISRCTN | ISRCTN13955395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13955395 |
| Secondary identifying numbers | HTA 17/23/02; Sponsor PID: 13849 |
- Submission date
- 12/10/2018
- Registration date
- 12/10/2018
- Last edited
- 01/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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 August 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
Contact information
Public
Kadoorie Centre
John Radcliffe Hospital
Oxford
OX39DU
United Kingdom
| Phone | +44 (0)1865 228929 |
|---|---|
| FORCE@ndorms.ox.ac.uk |
Scientific
Kadoorie Centre
John Radcliffe Hospital
Oxford
OX39DU
United Kingdom
 ORCID ID |
0000-0001-8420-8252 |
|---|
Study information
| Study design | Multi-centre prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Study type | Participant information sheet |
| 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 |
| Study acronym | FORCE |
| Study objectives | 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(s) | Approved 16/11/2018, West Midlands – Solihull Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; Email: NRESCommittee.WestMidlands-Solihull@nhs.net), ref: 18/WM/0324 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 02/07/2018 |
| Completion date | 31/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 696 |
| Total final enrolment | 965 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/11/2018 |
| Date of final enrolment | 12/07/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Oxford
OX3 9DU
United Kingdom
Liverpool
L12 2AP
United Kingdom
Birmingham
B4 6NH
United Kingdom
Bristol
BS2 8BJ
United Kingdom
Coventry
CV2 2DX
United Kingdom
Darlington
DL3 6HX
United Kingdom
Derby
DE22 3NE
United Kingdom
Banbury
OX16 9AL
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Leicester
LE1 5WW
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Romford
RM7 0AG
United Kingdom
E1 1BB
United Kingdom
Sheffield
S10 2TH
United Kingdom
London
SW17 0QT
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Wexham Park
Slough
SL2 4HL
United Kingdom
Barrack Rd
Exeter
EX2 5DW
United Kingdom
Westminster Bridge Rd
Lambeth
London
SE1 7EH
United Kingdom
Sponsor information
University/education
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
England
United Kingdom
| Website | http://www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/force |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 Added 27/03/2019: The protocol will be available prior to the completion of recruitment. The Statistical Analysis Plan and Health Economics Analysis Plan will be prepared before the final data has been collected. It is planned that each of these will be published in open-access journals. Added 30/12/2019: The protocol (not peer reviewed) has been uploaded as an additional file. |
| IPD sharing plan | The datasets generated during and analysed during the current study may be made available upon request. All data requests should be submitted to Daniel Perry (daniel.perry@ndorms.ox.ac.uk). Access to anonymised data may be granted following review. Data will be freely available after the Monograph is published, and for 5 years thereafter, for anyone to look up and to use for whatever purpose. Individual patient data will be made available for IPD met analysis only, subject to agreement. All data will be anonymised and any free text responses from participants removed to ensure this. All participants have consented to the study and there are no ethical or legal restrictions. Anonymised patient-level data will be shared in a format appropriate to the nature of the data-sharing project. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V3.0 | 13/11/2019 | 30/12/2019 | No | No |
| Protocol article | protocol | 01/06/2020 | 05/08/2020 | Yes | No |
| Statistical Analysis Plan | Statistical analysis plan | 01/06/2020 | 05/08/2020 | No | No |
| Basic results | 06/07/2022 | 06/07/2022 | No | No | |
| Participant information sheet | 06/07/2022 | No | Yes | ||
| Results article | 02/07/2022 | 06/07/2022 | Yes | No | |
| Other publications | Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT) | 13/07/2022 | 14/07/2022 | Yes | No |
| Results article | 01/07/2022 | 01/08/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
01/08/2022: Publication reference added.
14/07/2022: Publication reference added.
07/06/2022: The following changes have been made:
1. Publication reference added.
2. The participant information sheet link has been added.
3. A basic results file has been uploaded.
07/09/2021: The intention to publish date was changed from 14/01/2021 to 01/12/2021.
18/08/2020: IPD sharing statement added.
05/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 20/07/2020 to 12/07/2020.
2. The total final enrolment was added.
3. Publication references added.
06/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 20/07/2020.
2. The overall trial end date was changed from 14/01/2021 to 31/08/2020.
3. The intention to publish date was changed from 14/01/2022 to 14/01/2021.
30/12/2019: Protocol file uploaded.
10/12/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2019 to 30/06/2020.
2. The overall end date was changed from 30/06/2020 to 14/01/2021.
3. The intention to publish date was changed from 01/08/2020 to 14/01/2022.
4. The trial participating centres "University Hospital Southampton, Royal Berkshire Hospital, Wexham Park Hospital, Royal Devon & Exeter Hospitals, Evelina London Children's Hospital" were added.
5. The plain English summary was updated to reflect these changes.
16/10/2019: Internal review.
01/04/2019: Ethics approval details added.
27/03/2019: Publication and dissemination plan and IPD sharing statement updated, trial participating centres added.
