Operative or non-surgical treatment of Perthes’ disease

Plain English Summary

Background and study aims
Perthes’ disease is a rare condition of the hip joint and one of the most disabling conditions affecting children. It has a profound impact on the life of the child, and that of their family. The hip is a ‘ball and socket’ joint. This can be thought of as a scoop of ice cream, with the ice cream (the ‘ball’) sitting in an ice cream scoop (the ‘socket’). Perthes’ disease is caused by a problem with the blood supply to the hip, which means the ball doesn’t get enough oxygen and nutrients to grow. When this happens, the hip loses its strength and flattens - like the ice cream melting and becoming squashed. In Perthes’ disease there is a temporary loss of blood supply, which means that after some months the nutrients return, and the ball again hardens. However, the bone remains whatever shape it was when it became squashed. This can lead to a ball that doesn’t fit well into the socket, which can cause pain, limitation to usual activities and severe hip arthritis in childhood.
About half of the surgeons in the UK currently believe that surgery can be helpful in ‘controlling’ the way that the ball of the hip flattens, which could result in a better-shaped hip and better outcomes for children. Surgery involves breaking the bone to re-orientate the ball to ensure that it deforms in a controlled way into the socket (called ‘containment’ surgery). The other half of surgeons do not undertake surgery, instead focusing on a package of care (called ‘non-surgical or active containment’) that involves physiotherapy, activity restriction and pain relief. Physiotherapy aims to maintain movement of the hip and keep the soft ball moving within the socket, allowing it to continually smooth its shape – i.e. the ‘ice cream rolling within the scoop’. These surgeons believe that surgical containment is no better than active containment with the benefit that active containment does not expose the child to the unnecessary risks associated with surgery. Given how disabling Perthes’ disease is, and the differences in how it is treated, patients, families, and health professionals ranked the management of Perthes’ disease in the top five most important research priorities in children’s orthopaedic surgery. This study aims to find out whether containment surgery is better than active containment for helping patients with Perthes’ disease to be able to take part in activities.

Who can participate?
Children aged 5 years to 12 years inclusive with newly diagnosed Perthes’ disease

What does the study involve?
If you decide you would like your child to take part, a member of the team will ask you to complete:
1. A consent form. Children will also be asked to complete an assent form. This shows that they also give their permission.
2. A contact information form so we can contact you about your child’s progress.
3. A questionnaire about how the condition affects your child, pain, activities and feelings. This should take about 15 minutes. We will then allocate your child fairly to one of the two treatment groups in the study and the doctors and nurses will then begin treatment.
If you are allocated to active containment you will have a face-to-face personalised physiotherapy session with a therapist trained in this research study. They will spend time with you, discussing goals for your child in their recovery and providing education and advice around how to manage your child’s Perthes’ Disease. This will include discussions about how Perthes’ Disease progresses and what to expect in terms of timeframes. It will also involve education around how to manage pain that is common with Perthes’ Disease, this will involve advice about pain relief but also about how to manage pain without medication. The therapist will identify appropriate exercises, giving you access to a website and a mobile app that help guide the recovery through exercises and trustworthy sources of information. To enable active containment throughout recovery, the expertise of specially trained physiotherapists within specialist centres will be available to support local physiotherapists.
With your permission, the health professional might audio record the face-to-face personalised physiotherapy session to share with the central study team. The recording will be used to make sure the information is delivered in the best way. This is normal in research, but it is ok to say if you prefer not to have the session recorded. Any recording will be deleted 12 months after the research team checks it.
If you are allocated to surgery, your child will be scheduled for an operation, usually within about 4 months of the appointment. The surgery involves your child going to sleep with a general anaesthetic. When your child is asleep, a cut will be made in the skin and either the thigh (femur) or the hip (pelvis) bone will be divided. This surgery will realign the ball and socket of the hip, such that they fit together in the best way possible. The bone is then fixed to ensure that the ball sits well within the socket. This will try to help the hip to squash down and then regrow in the round shape of the socket. Depending on the type of surgery, your child may spend around 6 weeks in a special cast called a ‘spica’ and may need to use a wheelchair. Your child will have access to a physiotherapist after the surgery, which will be provided by the local treating physiotherapy team. Often, as your child recovers, a second operation is needed to remove any implants used to hold the bones in position.
During the research study, you will be seen for routine clinical follow-up at your treating hospital and we will have brief contact with you by text message and/or email on eight further occasions (3, 6, 9, 12, 18, 24, 30 and 36 months after enrolment). We will ask questions about pain, activities, how your child feels, hospital attendance, school attendance and costs that you may have incurred in relation to this hip problem (i.e. days absent from work etc.). For all children, we collect routinely taken radiographs for analyses.

What are the possible benefits and risks of participating?
The study compares the two treatments commonly used in the NHS. Each of the treatments has potential advantages and disadvantages.
1. Active containment’: The goals are to maximise movement of the hip allowing it to continually smooth its shape. The benefit is the activity encourages the hip ball to re-form in the round shape of the socket, without the need for surgery. This continues throughout the disease process, with families encouraged to engage with therapy at home with support from the physiotherapists. Despite this treatment, the hip may not grow into a normal shape, which could cause pain and arthritis in the future.
2. Containment surgery, is done by breaking and resetting the bones around the hip. Children may be put in a plaster cast for around 6 weeks. The benefit is that surgery directs the ball of the hip into the socket, encouraging the hip ball to re-form in the round shape of the socket. However, there are very small risks related to the anaesthetic, along with small risks of infection, wound problems, pain or stiffness, injury to nerves supplying the foot and problems related to the metal implants. Also, there is often a need for a second operation to remove any metal implants. Despite this treatment, the hip may not grow into a normal shape, which could cause pain and arthritis in the future.
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. The research team has a lot of experience in caring for children and young people with injuries and is active in health research. Parents and children have been involved in the development of this study and are involved in the management.

When is the study starting and how long is it expected to run for?
October 2023 to May 2030

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (reference NIHR152309) (UK)

Who is the main contact?
1. Prof. Daniel Perry, OPNon-STOP@ndorms.ox.ac.uk
2. Alder Hey Children’s NHS Foundation Trust, +44 (0)151 252 5570 or research@alderhey.nhs.uk

Study website

Contact information

Prof Daniel Perry
Public, 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
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

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

Alder Hey Hospital
Eaton Road
West Derby
Liverpool
L12 2AP
England
United Kingdom

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

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN83315571_PROTOCOL_V2.0_27Aug24.pdf

Editorial Notes

11/04/2025: Victoria Hospital, Royal Hospital for Children & Young People, Royal Free Hospital, and Royal Manchester Children's Hospital were added to the study participating centres.
06/02/2025: Nottingham University Hospitals NHS Trust was added to the study participating centres.
27/01/2025: University Hospital Southampton NHS Foundation Trust, University Hospitals of Leicester NHS Trust, and Great Ormond Street Hospital for Children NHS Foundation Trust were added to the study participating centres.
19/11/2024: The recruitment start date was changed from 14/11/2024 to 15/11/2024.
14/11/2024: Ethics approval details added. The recruitment start date was changed from 31/10/2024 to 14/11/2024.
09/10/2024: Protocol uploaded. Study website and IPD sharing plan added. The recruitment start date was changed from 07/10/2024 to 31/10/2024.
05/08/2024: The study hypothesis was updated.
29/07/2024: Study's existence confirmed by the NIHR.