Condition category
Injury, Occupational Diseases, Poisoning
Date applied
11/03/2019
Date assigned
18/03/2019
Last edited
19/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 August 2027

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

Trial website

http://www.sciencestudy.org

Contact information

Type

Scientific

Primary contact

Mrs Louise Spoors

ORCID ID

http://orcid.org/0000-0003-0488-0087

Contact details

Kadoorie Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41515; HTA 17/18/02

Study information

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

Acronym

SCIENCE

Study hypothesis

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

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

Study design

Randomised; Interventional; Design type: Treatment, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/10/2018

Overall trial end date

31/08/2027

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 334; UK Sample Size: 334

Participant 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

Recruitment start date

01/04/2019

Recruitment end date

31/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Aberdeen Children’s Hospital
Aberdeen
AB25 2ZG
United Kingdom

Trial participating centre

Airedale General Hospital
Skipton Road West Yorkshire
BD20 6TD
United Kingdom

Trial participating centre

Alder Hey Children’s Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom

Trial participating centre

Basingstoke & North Hampshire Hospital
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

The Royal Belfast Hospital for Sick Children
274 Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Trial participating centre

Birmingham Children's Hospital
Steelhouse Ln
Birmingham
B4 6NH
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Royal Alexandra Children’s Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Bristol Royal Hospital for Children
Upper Maudlin St
Bristol
BS2 8BJ
United Kingdom

Trial participating centre

University Hospital Wales
Heath Park Way
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Durham and Darlington (Hospital TBC)
-
United Kingdom

Trial participating centre

Glasgow (TBC)
-
United Kingdom

Trial participating centre

University Hospital Coventry
Clifford Bridge Rd
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Hull Royal Infirmary
Anlaby Rd
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Leeds General Infirmary
Great George St
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Luton and Dunstable Hospital
Lewsey Rd
Luton
LU4 0DZ
United Kingdom

Trial participating centre

Tunbridge Wells Hospital
Tonbridge Rd Pembury
Royal Tunbridge Wells
TN2 4QJ
United Kingdom

Trial participating centre

Royal Manchester Children's Hospital
Oxford Rd
Manchester
M13 9WL
United Kingdom

Trial participating centre

Milton Keynes University Hospital
Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Jenny Lind Children's Hospital
Norfolk and Norwich University Hospital Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Nottingham University Hospital (Queen's Medical Centre)
Derby Rd
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headly Way
OX3 9DU
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Rd
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Southwick Hill Rd Hampshire
PO6 3LY
United Kingdom

Trial participating centre

Royal London Hospital
Whitechapel
E1 1BB
United Kingdom

Trial participating centre

Royal Stoke University Hospital
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom

Trial participating centre

James Cook University Hospital
Marton Rd
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

University Hospital Southampton
Tremona Rd
Southampton
SO16 6YD
United Kingdom

Trial participating centre

St George's Hospital
Blackshaw Rd
London
SW17 0QT
United Kingdom

Trial participating centre

Morriston Hospital
Heol Maes Eglwys Morriston Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom

Trial participating centre

Arrowe Park Hospital
Arrowe Park Road Upton
Wirral
CH49 5PE
United Kingdom

Trial participating centre

Basildon University Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom

Trial participating centre

Broomfield Hospital
Court Rd Broomfield
Chelmsford
CM1 7ET
United Kingdom

Trial participating centre

Countess of Chester Hospital
Liverpool Rd
Chester
CH2 1UL
United Kingdom

Trial participating centre

Royal Cornwall Hospitals NHS Trust
Truro
TR1 3HD
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Epsom Hospital
Dorking Road
Epsom
KT18 7EG
United Kingdom

Trial participating centre

Evelina London Children's Hospital
Westminster Bridge Rd Lambeth
London
SE1 7EH
United Kingdom

Trial participating centre

Leighton Hospital
Middlewich Road Leighton
Crewe
CW1 4QJ
United Kingdom

Trial participating centre

Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

Medway Maritime Hospital
Windmill Road
Gillingham
ME7 5NY
United Kingdom

Trial participating centre

Northampton General Hospital
Cliftonville
Northampton
NN1 5BD
United Kingdom

Trial participating centre

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

Royal Berkshire Hospital
London Road Craven Road
Reading
RG1 5AN
United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Telford (TBC)
Telford
-
United Kingdom

Trial participating centre

Warrington (TBC)
Warrington
-
United Kingdom

Trial participating centre

Wexham Park Hospital
Wexham Park
Slough
SL2 4HL
United Kingdom

Trial participating centre

Whiston Hospital
Warrington Road
Prescot
L35 5DR
United Kingdom

Trial participating centre

Royal Hampshire County Hospital (RHCH)
Romsey Road
Winchester
SO22 5DG
United Kingdom

Trial participating centre

Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Trial participating centre

West Suffolk Hospital
Hardwick Ln
Bury Saint Edmunds
IP33 2QZ
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

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

Sponsor type

University/education

Website

Funders

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

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.