When children up to 11 years old break the bones in their wrists, do they need surgery to perfectly realign the bones, or will nature 'self-correct' the bones as they heal without restricting the use of the arm?
| ISRCTN | ISRCTN10931294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10931294 |
| IRAS number | 264593 |
| Secondary identifying numbers | CPMS 44878, IRAS 264593 |
- Submission date
- 24/02/2020
- Registration date
- 27/02/2020
- Last edited
- 19/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
The most common part of the body for a child to break is their wrist. Most need a simple plaster cast, but some undergo surgery to reset the bones before they go into a cast. These operations are really common, but doctors are unsure whether they are really necessary in younger children. In children up to 11 years old, even when the bones break and move totally out of place, there is evidence to suggest that the wrist will heal well and will grow back to normal over a few months. Parents and children want to know if surgery is really necessary, or whether a plaster cast with natural healing will be as good.
Who can participate?
All children aged 4-10 years old (inclusive) who have a severely broken wrist
What does the study involve?
Participants are randomly allocated either to be treated with a cast, allowing the arm to straighten naturally, or to be treated with a procedure to straighten the arm. Parents will be asked to complete some questions with their child about their pain, activities and feelings. These questions will be asked when if they decide to take part, and on four further occasions over the next 12 months. To assess the longer-term effects of the injury, the same questions will also be asked at the two and three year anniversary of the injury. Parents and children may be invited to take part in a sub-study exploring the experience of their child’s injury, its impact on their daily life and the parent’s experience of being asked to participate this study. A link to the questions will be sent to a mobile phone or email address and should take no more than 10 minutes to complete.
What are the possible benefits and risks of participating?
Both treatment options are currently being used to treat this type of injury and each carries a different set of risks. There are no additional risks to your child from taking part in the study. Risks of non-surgical treatment: the injured arm may not look the same as the other arm while it heals; healing may take longer and; in rare cases, if the arm does not grow straight an operation may be required. Risks of a procedure or operation to put the bones back into the right position: sometimes the doctors may have to make a cut in the arm to insert plates or wires to hold the bones in position, which would need to be removed at a later stage. The bone may still move out of place and in those who have an operation an infection may sometimes occur. Children in both groups are at risk of irritation related to the cast, pressure areas and a condition related to muscle swelling called compartment syndrome.
Where is the study run from?
University of Oxford, based at the John Radcliffe Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2019 to March 2027
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Daniel Perry
CRAFFT@ndorms.ox.ac.uk
Contact information
Scientific
University of Oxford, NDORMS
Kadoorie Centre
Level 3, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-8420-8252 |
|---|---|
| Phone | +44 (0)1865228929 |
| Daniel.Perry@ndorms.ox.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Surgery, Other |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | CRAFFT – Children’s Radius - Acute Fracture Fixation Trial: a multi-centre prospective randomised non-inferiority trial of surgical reduction versus non-surgical casting for displaced distal radius fractures in children |
| Study acronym | CRAFFT |
| Study hypothesis | Treatment with non-surgical casting is non-inferior to surgical reduction for the treatment of severely displaced fractures of the distal radius in children. |
| Ethics approval(s) | Approved 16/04/2020, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048106; nrescommittee.westmidlands-blackcountry@nhs.net), REC ref: 20/WM/0054 |
| Condition | Radius acute fracture |
| Intervention | This trial will compare two approaches to treat displaced distal radius fractures in children aged 4-10 years old inclusive. Participants are randomised to either: Non-surgical casting: This technique involves the application of a plaster cast to hold the bone fragments in the optimal possible position using analgesia, but without giving medication to deliberately alter the conscious level of the child. This may be the initial plaster cast used to stabilise the fracture, or the plaster cast may be changed by the clinician to maximise patient comfort and fracture stability. Although the principles of applying a plaster cast are inherent in the technique, in this pragmatic trial the type of casting material, extent of the cast and the details of the technique will be left to the discretion of the treating clinician as per their usual technique. A record will be made of the cast details and any cast changes. The usual practice is for the plaster cast to be used for 4-6 weeks. A procedure or operation: A procedure or operation will be performed (with or without fixation). The bones will be realigned under general anaesthesia or sedation altering the conscious state of the child. The method used to hold the bones in position will be at the discretion of the clinician; i.e. plaster cast alone, plaster cast and wires, plaster cast and plate. A record will be made of the operative details, the cast details and any cast changes. Following surgery, the usual practice is for the arm to be immobilised in a cast for 4-6 weeks. Specific details on the techniques and materials used in theatre will be collected for each participant. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Functional recovery assessed using the Patient Report Outcomes Measurement System (PROMIS Bank v2.0) Upper Extremity Score for Children Computer Adaptive Test (CAT) at 3 months post-treatment |
| Secondary outcome measures | 1. Upper extremity function is measured using the PROMIS Upper Extremity Score during the first year post-treatment 2. Pain is measured using the Wong-Baker FACES Pain Scale (an ordinal assessment using a series of six facial-expressions to illustrate the degree of pain intensity) during the first year post-treatment 3. Health-related quality of life is measured using EQ-5D-Y (Youth version) between during the first year post-treatment 4. Complication rate, including re-fracture, the need for further operative fixation and the absence of radiographic remodelling, measured through a qualitative assessment of radiographs by a surgeon consensus group up to 1-year post-treatment 5. Cost-effectiveness of the treatments to the NHS and the broader economy is measured by collecting resource use information, including inpatient/outpatient hospital attendance, other NHS or private services and out of pocket expenses up to 1-year post-treatment 6. Parental satisfaction with the cosmetic appearance of the arm measured using a visual analogue score (VAS) during the first year post-treatment 7. Patient satisfaction with care measured using an ordinal satisfaction score during the first year post-treatment 8. An assessment of impact of injury, treatment and recovery on parent and child experience of daily life and the outcomes that are important to them will be measured through qualitative interview during the first year post-treatment 9. The barriers and facilitators to trial recruitment from parent/child and staff perspectives will be measured through qualitative interview during the first year post-treatment Long-term outcomes to be reported separately: 10. Longer-term pain, function and complications will be measured using the methods described above (i.e. Wong-Baker, PROMIS-UE and complications record) annually up until 3 years post-treatment |
| Overall study start date | 01/12/2019 |
| Overall study end date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 750; UK Sample Size: 750 |
| Total final enrolment | 750 |
| Participant inclusion criteria | 1. Male and female children aged 4 to 10 years inclusive 2. Parents/guardians willing and able to give informed consent for their child’s participation in the study 3. There is radiographic evidence of a severely displaced wrist fracture at or adjacent to the physis (Salter-Harris II or a metaphyseal fracture); with or without a corresponding ulna fracture 4. The treating clinician believes that they may benefit from surgical reduction with or without fixation |
| Participant exclusion criteria | 1. The injury is more than 7 days old 2. The injury is part of a more complex wrist fracture (i.e. open or fracture extending into the joint) 3. There are other fractured bones elsewhere in the body, in addition to the affected wrist injury 4. There is evidence that the patient and/or parent 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 mobile data/internet |
| Recruitment start date | 11/08/2020 |
| Recruitment end date | 31/05/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Cambridge
CB2 0QQ
United Kingdom
Liverpool
L12 2AP
United Kingdom
RG24 9NA
United Kingdom
Birmingham
B4 6NH
United Kingdom
Bristol
BS2 8BJ
United Kingdom
Epsom
KT18 7EG
United Kingdom
Hull
HU3 2JZ
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Leeds
LS1 3EX
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Taunton
TA1 5DA
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Wigan Rd
Ormskirk
L39 2AZ
United Kingdom
Hampshire
PO6 3LY
United Kingdom
AB25 2ZG
United Kingdom
Brighton
BN2 5BE
United Kingdom
Reading
RG1 5AN
United Kingdom
Truro
TR1 3LQ
United Kingdom
E1 1BB
United Kingdom
Manchester
M13 9WL
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
NE1 4LP
United Kingdom
Sheffield
S10 2TH
United Kingdom
London
SW17 0QT
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Coventry
CV2 2DX
United Kingdom
Southampton
SO16 6YD
United Kingdom
Barnsley
S75 2EP
United Kingdom
Basildon
SS16 5NL
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Frimley
Surrey
GU16 7U
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Kettering
Northants
NN16 8UZ
United Kingdom
Sutton In Ashfield
NG17 4JL
United Kingdom
WV10 0QP
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Harlow
Essex
CM20 1QX
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Stockport
SK2 7JE
United Kingdom
Torquay
TA2 7AA
United Kingdom
Dunfermline
Fife
KY12 0SU
United Kingdom
Warrington
WA5 1QG
United Kingdom
Slough
SL2 4HL
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Joint Research Office, 1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 289886 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 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. Planned publication will be via high-impact peer-reviewed journals, and will be disseminated on social media using infographics and cartoons around one year after the trial has ended. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/07/2024: Total final enrolment added.
20/11/2023: The following changes have been made:
1. The recruitment end date has been changed from 30/11/2023 to 31/05/2024.
2. The overall study end date has been changed from 31/05/2025 to 31/03/2027 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/05/2026 to 31/03/2028.
23/06/2023: Wythenshawe Hospital was added to the trial participating centres.
13/01/2023: Leicester Royal Infirmary, Evelina London Children's Hospital, Peterborough City Hospital and Broomfield Hospital were removed from the trial participating centres.
12/01/2023: Bradford Royal Infirmary, Southend Hospital, Yeovil District Hospital and Ysbyty Gwynedd Hospital were added as trial participating centres.
07/04/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2022 to 30/11/2023.
2. The overall trial end date was changed from 30/10/2023 to 31/05/2025.
3. The intention to publish date was changed from 30/10/2024 to 31/05/2026.
21/09/2021: Internal review.
21/07/2021: The following changes have been made:
1. The trial participating centres "Addenbrooke's Hospital", "Barnsley Hospital", "Basildon University Hospital", "Broomfield Hospital", "Doncaster Royal Infirmary and Bassetlaw Hospital", "Evelina London Children's Hospital", "Frimley Park Hospital", "Gloucester Royal Hospital", "Doncaster Royal Infirmary and Bassetlaw Hospital", "Evelina London Children's Hospital", "Frimley Park Hospital", "Gloucester Royal Hospital", "John Radcliffe Hospital & Horton Hospital", "Kettering General Hospital", "Kings Mill Hospital", "New Cross Hospital", "Pinderfields Hospital", "Princess Alexandra Hospital NHS Trust", "Royal Blackburn Hospital", "Stepping Hill Hospital", "Torbay Hospital", "Victoria Hospital Kirkcaldy & Queen Margaret Hospital", "Warrington Hospital", and "Wexham Park Hospital" have been added.
2. The trial participating centres "Airedale General Hospital", "Bradford Royal Infirmary", "Countess of Chester Hospital", and "Hinchingbrooke Hospital" have been removed.
3. The trial participating centre "John Radcliffe Hospital" has been changed to "John Radcliffe Hospital & Horton Hospital".
12/08/2020: The recruitment start date was changed from 01/08/2020 to 11/08/2020.
27/07/2020: The following changes were made to the trial record:
1. The ethics approval details were added.
2. The recruitment start date was changed from 01/04/2020 to 01/08/2020.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
24/02/2020: Trial's existence confirmed by the NIHR.
