Amongst children with a slipped capital femoral epiphysis, does keyhole surgery to stabilise the bone or major surgery to reconstruct the bone give the best outcome at 2 years?

Plain English summary of protocol

Background and study aims
A slipped capital femoral epiphysis (SCFE) is a rare condition but is one of the most important children’s and adolescent hip disorders. SCFE is the most common reason for hip replacement surgery in adolescence and early adulthood. The number of children and young people with this condition is increasing, as there is strong evidence to suggest it is principally caused by obesity. A survey of almost 100 surgeons from the British Society for Children’s Orthopaedic Surgery prioritised this as their most important research question.
The simplest explanation of the disease is to imagine the hip like a ball of ice cream (the top of the hip) on an ice cream cone (the thigh bone). As a result of the disease, the ice cream ball could melt and slip a little away from the cone (minor slip) or slip a lot (severe slip) or could just come loose from the cone completely (unstable slip). Unstable slips are particularly worrisome as the supply of blood, which gives the bone nutrition and oxygen to remain healthy, could stop completely, which may cause the whole hip to die (with the ice cream ball becoming very squashed).
The treatment of SCFE always involves surgery to stabilise the slip, however, which type of surgery is necessary depends on how bad the slip is. In mild slips, surgery involves inserting a screw using keyhole surgery, to stop the hip slipping any more (this is called ‘stabilising’). For severe slips, where the hip bone is most deformed, doctors currently can choose between two types of operation and it is not clear whether one is better than the other. The first treatment option is inserting a screw through keyhole surgery (stabilising but not putting the ice cream back on the cone) and accepting that the shape of the hip has changed. This may cause problems with walking and may risk later osteoarthritis. The second option is to correct the slip through major surgery (stabilising and putting the ice cream back on the cone). However, this could make the hip unstable and carries a risk that the hip bone may disintegrate (i.e., a very squashed ice cream) causing disability.
The main aim of the study is to determine whether children treated with acute correction have improved function compared with children treated with pinning in situ after 2 years.

Who can participate?
Children aged between 8 and 15 years old with a stable severe SCFE

What does the study involve?
Participants are randomly allocated to one of the two treatments. During their recovery, participants will be seen for routine clinical follow-up at their treating hospital and will be contacted by text message and/or email on five further occasions (8 weeks, 3, 6, 12 and 24 months after enrolment). They will be asked questions about pain, activities, feelings, hospital attendance, school attendance and costs that they may have incurred in relation to this hip problem (e.g., days absent from work.)

What are the possible benefits and risks of participating?
The study compares the two treatments commonly used in the NHS. Each of these routinely used treatments has potential advantages and disadvantages.
Corrective surgery to improve the shape and stabilise the hip with screw(s) will correct the hip back to its natural position, which surgeons believe should improve hip movement and function. The main risk is damaging the blood supply feeding the hip, which may cause the hip to squash and change shape, which could cause early arthritis. This could cause problems with walking and may risk later arthritis and the need for further surgery in early adulthood.
Keyhole surgery to stabilise the hip with screw(s) without correcting the deformity can avoid major surgery in the short term and minimise the chance of damage to the blood supply feeding the hip. The main risk is that the child may suffer from pain or have problems with activities as the shape of the hip is not normal. This could cause problems with walking and may risk later arthritis and the need for further surgery in early adulthood.
There will be extra surveys and questionnaires to complete.

Where is the study run from?
Alder Hey Children’s NHS Foundation Trust is the sponsor for the study and has overall responsibility for the management of it. This study will be overseen by Oxford Clinical Trials Research Unit (OCTRU) with the day-to-day running of the study being completed by Oxford Trauma and Emergency Care at the University of Oxford (UK)

When is the study starting and how long is it expected to run for?
November 2021 to October 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (UK)

Who is the main contact?
Prof. Daniel Perry, BigBOSS@ndorms.ox.ac.uk

Study website

Contact information

Prof Daniel Perry
Scientific

University of Liverpool
Dept Child Health
Alder Hey Children's NHS Foundation Trust
Alder Hey Children's Hospital
Eaton Road
Liverpool
L14 5AB
United Kingdom

ORCID ID	0000-0001-8420-8252
Phone	+44 (0)151 282 4661
Email	danperry@liverpool.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom
• Wales

Study participating centres

Sponsor information

Alder Hey Children's NHS Foundation Trust
Hospital/treatment centre

Sponsorship Office
Clinical Research Division
Liverpool
L14 5AB
England
United Kingdom

Phone	+44 (0)151 252 5570
Email	research@alderhey.nhs.uk
"ROR"	https://ror.org/00p18zw56

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

23/08/2024: Hull University Teaching Hospitals NHS Trust was added as a study participating centre.
26/07/2024: Leicester Royal Infirmary was added as a study participating centre.
14/03/2024: The study participating centres Norfolk and Norwich University Hospitals NHS Foundation Trust, Maidstone and Tunbridge Wells NHS Trust, Guy’s and St Thomas’ NHS Foundation Trust, Southend University Hospital, Broomfield Hospital, University Hospitals of North Midlands NHS Trust, Imperial College Healthcare NHS Trust, Royal Free NHS Foundation Trust were added.
01/02/2024: Publication reference added.
02/11/2023: The recruitment start date was changed from 18/09/2023 to 02/11/2023.
20/09/2023: A link to the HRA research summary was added.
05/09/2023: The recruitment start date was changed from 19/06/2023 to 18/09/2023.
24/05/2023: Internal review.
15/05/2023: Study's existence confirmed by the NIHR.