Surgery or cast for injuries of the epicondyle in children’s elbows
| ISRCTN | ISRCTN16619778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16619778 |
| IRAS number | 259931 |
| Secondary identifying numbers | CPMS 41515; HTA 17/18/02, IRAS 259931 |
- Submission date
- 11/03/2019
- Registration date
- 18/03/2019
- Last edited
- 09/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Broken bones of the elbow are common in children. Doctors have varying opinions about the best treatment for one particular type of elbow break, called a ‘medial epicondyle fracture’. Some surgeons argue that these breaks should be treated with surgery to fix the bone with wires or screws, whilst others argue that treating the bone in a cast will give just as good results, without the risks and scars associated with surgery. The research to now is of poor quality and has results supporting both arguments. This means that the treatment that children receive is dependent on the beliefs and understanding of the surgeon, rather than proper science. Perhaps unsurprisingly, half of children in the UK are treated with surgery, and half with a cast. High-quality research is urgently needed to answer this question. Children, parents and doctors all agree that how well a child can use their arm is the most important thing to find out.
Who can participate?
Children with this injury (medial epicondyle fracture of the elbow) are usually around 10/11 years old, though anyone between 7 and 15 years can participate. It is hoped that 334 children will participate over a two year period from more than 35 hospitals. This number is calculated based on previous scientific research to ensure that the study is large enough to reach a firm conclusion.
What does the study involve?
Participants are randomly allocated to either rest the arm in plaster cast for up to 4 weeks to allow it to heal by itself, or to undergo surgery to fix the bone, usually with a screw and a splint or cast for up to 4 weeks. Questions will be asked just after the doctors have found out the elbow is broken, and then after 6 weeks, 3, 6 and 12 months. The most important follow-up point is at 12 months, which is called the ‘primary outcome’. The researchers will ask questions about pain, activities, feelings, hospital attendances, school attendance and costs incurred in relation to this injury. Parents have advised to avoid lots of paper documents, instead a website and videos/animations will be used to explain the study, and e-mails and text messages will be used to keep in touch with families. Further questions will be asked annually until the child reaches the age of 16.
What are the possible benefits and risks of participating?
Each of these routinely used treatments has potential advantages and disadvantages. Resting the arm in a plaster cast avoids surgery but healing may be slower, which may lead to an unstable elbow causing pain, stiffness and/or clunking and may rarely need more complex surgery later on. Surgery to fix the bone may lead to faster healing, but there are risks of surgery which include those associated with an anaesthetic (low risk), wound healing problems, pain or stiffness, injury to nerves supplying the fingers and breakage of the bone or metal. There is commonly the need for a second surgery to remove the screw once the bone has healed.
Where is the study run from?
The study is run from the University of Oxford, based at the John Radcliffe Hospital in Oxford, UK
When is the study starting and how long is it expected to run for?
October 2018 to December 2029
Who is funding the study?
National Institute for Health Research, Health Technology Assessment (UK)
Who is the main contact?
Mr Daniel Perry
sciencekids@ndorms.ox.ac.uk
Contact information
Scientific
Kadoorie Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0003-0488-0087 |
|---|---|
| Phone | +44 (0)1865 228929 |
| SCIENCEKids@ndorms.ox.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Surgery |
|---|---|
| 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 | Surgery or Cast for Injuries of the EpicoNdyle in Children’s Elbows (SCIENCE): a multi-centre prospective randomised superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures of the humerus in children |
| Study acronym | SCIENCE |
| Study objectives | The aim of this pragmatic randomised controlled trial is to evaluate the clinical and cost-effectiveness of operative fixation versus non-operative treatment for displaced medial epicondyle fractures of the elbow in children. |
| Ethics approval(s) | Approved 25/03/2019, North West Greater Manchester Central (3rd Floor Barlow House HRA RES Centre- Manchester M1 3DZ; +44 (0)207 104 8225; nrescommittee.northwest-gmcentral@nhs.net), ref: 19/NW/0158 |
| Health condition(s) or problem(s) studied | Medial epicondyle fractures of the humerus |
| Intervention | Current interventions as of 19/07/2019: Randomisation: The patient will be randomised after consent. All hospital treatment areas have access to the internet so will access the randomisation service in real time i.e. there will be no delay in patient treatment. Consented children will be randomised to one of two intervention groups (1:1) using a computer randomisation service provided by OCTRU. Randomisation will be performed using a minimisation algorithm including a random element to ensure balanced allocation of participants across the two treatment groups stratified by centre and dislocation status of the elbow at presentation (i.e. dislocated or not dislocated). Operative fixation: Children are admitted to hospital for surgery, which typically is scheduled on a daytime trauma operating session, though patients can be enrolled irrespective of the time of presentation/ surgery. Children undergo a general anaesthetic. After the skin has been covered in antiseptic, an incision will be made over the medial epicondyle paying particular attention to the location of the ulna nerve. The bone fragments will be opposed in the optimal position achievable under direct vision. A record will be made of the type of fixation used. The bone fragments will be fixed using the preferred technique of the surgeon (i.e. screw/wire(s)). Although, the basic principles of fixation are inherent in the technique, there are several different options available to the surgeon, with the most common being screw fixation. The type of implant, size and insertion technique are not believed to affect the outcome, and will be left entirely to the discretion of the surgeon as per their normal practice. At the end of the procedure, a sling/plaster/splint/bandage will be applied as per the standard surgical practice. The elbow will be allowed to mobilise as per the usual practice of the treating surgeon under the direction of the clinical team, though fixed immobilisation in a cast should not be used for more than 4 weeks post randomisation. Non-operative treatment; This technique involves immobilisation of the elbow to rest the elbow at around 90 degrees of flexion. The immobilisation device (i.e. cast/splint/bandage etc) is not applied with the intention of directly opposing the bone fragments, and therefore the bone fragments will not align perfectly. In this pragmatic trial the duration and method of immobilisation will be left to the discretion of the treating surgeon as per their usual technique, and will be worn as per the standard practice of the treating surgeon. Subsequently, the elbow will be allowed to mobilise as pain allows under the direction of the clinical team. Fixed immobilisation in a cast should not be used for more than 4 weeks post randomisation. Previous interventions: Randomisation: The patient will be randomised after consent. All hospital treatment areas have access to the internet so will access the randomisation service in real time i.e. there will be no delay in patient treatment. Consented children will be randomised to one of two intervention groups (1:1) using a computer randomisation service provided by OCTRU. Randomisation allocation will be implemented using stratification by centre and elbow dislocation status on presentation to the emergency department with randomisation schedules prepared by the trial statistician and embedded in the online system. Operative fixation; Children are admitted to hospital for surgery, which typically is scheduled on a daytime trauma operating session, though patients can be enrolled irrespective of the time of presentation/ surgery. Children undergo a general anaesthetic. After the skin has been covered in antiseptic, an incision will be made over the medial epicondyle paying particular attention to the location of the ulna nerve. The bone fragments will be opposed in the optimal position achievable under direct vision. A record will be made of the type of fixation used. The bone fragments will be fixed using the preferred technique of the surgeon (i.e. screw/wire(s)). Although, the basic principles of fixation are inherent in the technique, there are several different options available to the surgeon, with the most common being screw fixation. The type of implant, size and insertion technique are not believed to affect the outcome, and will be left entirely to the discretion of the surgeon as per their normal practice. At the end of the procedure, a sling/plaster/splint/bandage will be applied as per the standard surgical practice. The elbow will be allowed to mobilise as per the usual practice of the treating surgeon under the direction of the clinical team, though fixed immobilisation in a cast should not be used for more than 4 weeks post randomisation. Non-operative treatment; This technique involves immobilisation of the elbow to rest the elbow at around 90 degrees of flexion. The immobilisation device (i.e. cast/splint/bandage etc) is not applied with the intention of directly opposing the bone fragments, and therefore the bone fragments will not align perfectly. In this pragmatic trial the duration and method of immobilisation will be left to the discretion of the treating surgeon as per their usual technique, and will be worn as per the standard practice of the treating surgeon. Subsequently, the elbow will be allowed to mobilise as pain allows under the direction of the clinical team. Fixed immobilisation in a cast should not be used for more than 4 weeks post randomisation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Upper limb function measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children at 1 year post-randomisation |
| Secondary outcome measures | 1. Upper limb function measured using the PROMIS Upper Extremity Score at Week 6, Months 3 and 6 2. Sports and performing arts participation measured using the DASH S/PA Module (a validated assessment of higher-level upper limb function) at Week 6, Months 3, 6 and 12 3. Pain measured using the Wong-Baker FACES Pain Rating Scale at Week 6, Months 3, 6 and 12 4. Quality of life measured using EQ5DY at Week 6, Months 3, 6 and 12 5. Complication rate, including the need for further operative fixation, at Weeks 4 and 6, Months 3, 6 and 12 6. Cost-effectiveness of the two treatments to the NHS and broader society at Months 3, 6 and 12 7. Barriers and facilitators to recruitment to this study and other paediatric surgical trials (pilot phase only) assessed using qualitative interviews with children, parent/guardians and trial staff |
| Overall study start date | 01/10/2018 |
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 300, Overseas: 34 |
| Total final enrolment | 335 |
| Key inclusion criteria | 1. Radiographic evidence of a displaced medial epicondyle fracture of the humerus, with fracture displacement determined by the surgeon as per their usual clinical practice 2. Aged between 7 and 15 years old inclusive |
| Key exclusion criteria | 1. The injury is more than two weeks old 2. There is incarceration of the medial epicondyle fragment within the elbow joint 3. The injury is part of a complex elbow fracture (i.e. fracture extending into the joint) 4. There are other fractured bones elsewhere in the body, in addition to the elbow injury 5. The elbow, if dislocated, is unable to be realigned into a satisfactory position in the emergency department. 6. 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 the internet |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 22/09/2023 |
Locations
Countries of recruitment
- Australia
- England
- New Zealand
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
AB25 2ZG
United Kingdom
West Yorkshire
BD20 6TD
United Kingdom
Liverpool
L12 2AP
United Kingdom
RG24 9NA
United Kingdom
Belfast
BT12 6BA
United Kingdom
Birmingham
B4 6NH
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Brighton
BN2 5BE
United Kingdom
Bristol
BS2 8BJ
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Coventry
CV2 2DX
United Kingdom
Hull
HU3 2JZ
United Kingdom
Leeds
LS1 3EX
United Kingdom
Leicester
LE1 5WW
United Kingdom
Luton
LU4 0DZ
United Kingdom
Pembury
Royal Tunbridge Wells
TN2 4QJ
United Kingdom
Manchester
M13 9WL
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
NE1 4LP
United Kingdom
Colney Lane
Norwich
NR4 7UY
United Kingdom
Nottingham
NG7 2UH
United Kingdom
OX3 9DU
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Hampshire
PO6 3LY
United Kingdom
E1 1BB
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Sheffield
S10 2TH
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Southampton
SO16 6YD
United Kingdom
London
SW17 0QT
United Kingdom
Upton
Wirral
CH49 5PE
United Kingdom
Basildon
SS16 5NL
United Kingdom
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Chester
CH2 1UL
United Kingdom
TR1 3HD
United Kingdom
Derby
DE22 3NE
United Kingdom
Epsom
KT18 7EG
United Kingdom
Lambeth
London
SE1 7EH
United Kingdom
Leighton
Crewe
CW1 4QJ
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Gillingham
ME7 5NY
United Kingdom
Northampton
NN1 5BD
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Craven Road
Reading
RG1 5AN
United Kingdom
London
NW3 2QG
United Kingdom
SP2 8BJ
United Kingdom
Sunderland
SR4 7TP
United Kingdom
-
United Kingdom
Slough
SL2 4HL
United Kingdom
Prescot
L35 5DR
United Kingdom
Winchester
SO22 5DG
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Bury Saint Edmunds
IP33 2QZ
United Kingdom
Barnsley
S75 2EP
United Kingdom
Bedford
MK42 9DJ
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Frimley
Camberley
GU16 7UJ
United Kingdom
Gorleston-on-Sea
Great Yarmouth
NR31 6LA
United Kingdom
Kettering
NN16 8UZ
United Kingdom
TA1 5DA
United Kingdom
Ormskirk
L39 2AZ
United Kingdom
PE3 9GZ
United Kingdom
Dunfermline
KY12 0SU
United Kingdom
Sutton In Ashfield
NG17 4JL
United Kingdom
Southend-on-Sea
SS0 0RY
United Kingdom
South Shields
NE34 0PL
United Kingdom
Grafton
Auckland
1023
New Zealand
Parkville
3052
Australia
Westmead
2145
Australia
South Brisbane
4101
Australia
Harlow
CM20 1QX
United Kingdom
Exeter
EX2 5DW
United Kingdom
Newton Rd
Torquay
TQ2 7AA
United Kingdom
Sponsor information
University/education
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
OX3 7GB
England
United Kingdom
"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 | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 of the results 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 (2023). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the chief investigator (Daniel.perry@ndorms.ox.ac.uk). Applications will be considered by the Oxford Trauma and Emergency Care senior management group, with the intention to release anonymised data to academic groups for the purpose of high-quality individual patient data meta-analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V4.0 | 10/03/2021 | 07/04/2021 | No | No |
| Protocol file | version v5.0 | 07/06/2021 | 27/07/2021 | No | No |
| Protocol file | version 6.0 | 19/08/2021 | 23/08/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other files | Health economics analysis plan version 1.0 |
20/08/2024 | 09/01/2025 | No | No |
| Statistical Analysis Plan | version 1.0 | 31/10/2024 | 09/01/2025 | No | No |
Additional files
- ISRCTN16619778_Protocol_V4.0_10Mar2021.pdf
- uploaded 07/04/2021
- ISRCTN16619778_PROTOCOL_V5.0_07Jun21.pdf
- ISRCTN16619778_PROTOCOL_V6.0_19Aug21.pdf
- ISRCTN16619778_SAP_V1.0_31Oct24.pdf
- ISRCTN16619778_HEAP_V1.0_20Aug24.pdf
- Health economics analysis plan
Editorial Notes
09/01/2025: Statistical Analysis Plan, Health Economics Analysis Plan and total final enrolment added.
27/09/2023: The following changes were made:
1. Added IRAS number.
2. The recruitment end date was changed from 30/09/2023 to 22/09/2023.
05/09/2023: The participant level data sharing statement was added.
01/09/2023: The contact confirmed the record is up to date.
15/05/2023: The intention to publish date has been changed from 31/05/2023 to 30/09/2025.
24/03/2023: The trial participating centre Torbay Hospital was added.
03/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2023 to 30/09/2023.
2. The overall end date was changed from 31/08/2027 to 31/12/2029.
3. The plain English summary was updated to reflect these changes.
06/04/2022: The recruitment end date was changed from 31/05/2022 to 30/11/2023.
23/08/2021: Uploaded protocol (not peer-reviewed), Version 6, 19 August 2021.
27/07/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version 5, 07 June 2021.
2. The target number of participants was changed from 'Planned Sample Size: 334; UK Sample Size: 334' to 'UK Sample Size: 300, Overseas: 34'.
3. Princess Alexandra Hospital and Royal Devon and Exeter Hospital were added as trial participating centres.
07/04/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version 4, 10 March 2021.
2. The trial participating centres "Durham and Darlington (Hospital TBC), Glasgow (TBC), Morriston Hospital, Telford (TBC)" were removed.
3. The trial participating centres "Barnsley Hospital, Bedford Hospital, Blackpool Victoria Hospital, Addenbrooke's Hospital, Doncaster Royal Infirmary, Frimley Park Hospital, James Paget University Hospital, Kettering General Hospital, Musgrove Park Hospital, Ormskirk District General Hospital, Peterborough City Hospital, Kings Mill Hospital, Southend Hospital, South Tyneside District Hospital, Starship Children's Hospital (New Zealand), The Royal Children’s Hospital Melbourne (Australia), The Children’s Hospital at Westmead (Australia), Children’s Health Queensland Hospital and Health Service (Australia)" were added.
22/03/2021: The following changes were made to the trial record:
1. The recruitment resumed.
2. The recruitment end date was changed from 31/05/2021 to 31/05/2022.
12/06/2020: The scientific contact's details have been changed.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
19/07/2019: The following changes were made to the trial record:
1. The ethics approval was added.
2. The ORCID ID was added for Louise Spoors.
3. The interventions were changed.
4. The trial participating centres "The Robert Jones and Agnes Hunt Orthopaedic Hospital and Colchester General Hospital" were removed, the following trial participating centres were added: Arrowe Park Hospital, Basildon University Hospital, Broomfield Hospital, Countess of Chester Hospital, Royal Cornwall Hospitals NHS Trust, Royal Derby Hospital, Epsom Hospital, Evelina London Children's Hospital, Leighton Hospital, Macclesfield District General Hospital, Medway Maritime Hospital, Northampton General Hospital, Pinderfields Hospital, Royal Berkshire Hospital, Royal Free Hospital, Salisbury District Hospital, Sunderland Royal Hospital, Telford, Warrington, Wexham Park Hospital, Whiston Hospital, Royal Hampshire County Hospital (RHCH), Yeovil District Hospital, West Suffolk Hospital.
07/06/2019: Internal review.
