Surgery or cast for injuries of the epicondyle in children’s elbows
| ISRCTN | ISRCTN16619778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16619778 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 259931 |
| Protocol serial number | CPMS 41515; HTA 17/18/02, IRAS 259931 |
| Sponsor | University of Oxford |
| Funder | Health Technology Assessment Programme |
- Submission date
- 11/03/2019
- Registration date
- 18/03/2019
- Last edited
- 29/01/2026
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Treatment, Surgery |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Upper limb function measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children at 1 year post-randomisation |
| Key secondary outcome measure(s) |
1. Upper limb function measured using the PROMIS Upper Extremity Score at Week 6, Months 3 and 6 |
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 334 |
| 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
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
- Australia
- New Zealand
Study participating centres
Aberdeen
AB25 2ZG
Scotland
West Yorkshire
-
BD20 6TD
England
Liverpool
L12 2AP
England
Basingstoke
RG24 9NA
England
Belfast
BT12 6BA
Northern Ireland
Birmingham
B4 6NH
England
Bradford
BD9 6RJ
England
Brighton
BN2 5BE
England
Bristol
BS2 8BJ
England
Cardiff
CF14 4XW
Wales
Coventry
CV2 2DX
England
Hull
HU3 2JZ
England
Leeds
LS1 3EX
England
Leicester
LE1 5WW
England
Luton
LU4 0DZ
England
Pembury
Royal Tunbridge Wells
TN2 4QJ
England
Manchester
M13 9WL
England
Eaglestone
Milton Keynes
MK6 5LD
England
Newcastle upon Tyne
NE1 4LP
England
Colney Lane
Norwich
NR4 7UY
England
Nottingham
NG7 2UH
England
-
OX3 9DU
England
Plymouth
PL6 8DH
England
Hampshire
-
PO6 3LY
England
-
E1 1BB
England
Stoke-on-Trent
ST4 6QG
England
Sheffield
S10 2TH
England
Middlesbrough
TS4 3BW
England
Southampton
SO16 6YD
England
London
SW17 0QT
England
Upton
Wirral
CH49 5PE
England
Basildon
SS16 5NL
England
Broomfield
Chelmsford
CM1 7ET
England
Chester
CH2 1UL
England
Truro
TR1 3HD
England
Derby
DE22 3NE
England
Epsom
KT18 7EG
England
Lambeth
London
SE1 7EH
England
Leighton
Crewe
CW1 4QJ
England
Macclesfield
SK10 3BL
England
Gillingham
ME7 5NY
England
Northampton
NN1 5BD
England
Wakefield
WF1 4DG
England
Craven Road
Reading
RG1 5AN
England
London
NW3 2QG
England
Salisbury
SP2 8BJ
England
Sunderland
SR4 7TP
England
Warrington
-
England
Slough
SL2 4HL
England
Prescot
L35 5DR
England
Winchester
SO22 5DG
England
Yeovil
BA21 4AT
England
Bury Saint Edmunds
IP33 2QZ
England
Barnsley
S75 2EP
England
Bedford
MK42 9DJ
England
Blackpool
FY3 8NR
England
Cambridge
CB2 0QQ
England
Doncaster
DN2 5LT
England
Frimley
Camberley
GU16 7UJ
England
Gorleston-on-Sea
Great Yarmouth
NR31 6LA
England
Kettering
NN16 8UZ
England
Taunton
TA1 5DA
England
Ormskirk
L39 2AZ
England
Peterborough
PE3 9GZ
England
Dunfermline
KY12 0SU
Scotland
Sutton In Ashfield
NG17 4JL
England
Southend-on-Sea
SS0 0RY
England
South Shields
NE34 0PL
England
Harlow
CM20 1QX
England
Exeter
EX2 5DW
England
Newton Rd
Torquay
TQ2 7AA
England
Grafton
Auckland
1023
New Zealand
Parkville
3052
Australia
Westmead
2145
Australia
South Brisbane
4101
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | 20/01/2026 | 29/01/2026 | Yes | 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 |
| 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 |
| Statistical Analysis Plan | version 1.0 | 31/10/2024 | 09/01/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN16619778_Protocol_V4.0_10Mar2021.pdf
- uploaded 07/04/2021
- ISRCTN16619778_PROTOCOL_V5.0_07Jun21.pdf
- Protocol file
- ISRCTN16619778_PROTOCOL_V6.0_19Aug21.pdf
- Protocol file
- ISRCTN16619778_SAP_V1.0_31Oct24.pdf
- Statistical Analysis Plan
- ISRCTN16619778_HEAP_V1.0_20Aug24.pdf
- Health economics analysis plan
Editorial Notes
29/01/2026: Publication reference added.
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.
