Op Non-STOP Study (Operative or Non-Surgical Treatment of Perthes’ disease). A multi-centre prospective randomised superiority trial of containment surgery compared to optimised non-surgical care for Perthes’ disease of the hip in children
Perthes’ disease
The proposed project is a two-phase trial. Phase 1 (internal pilot) will take place at a minimum of 15 centres over a 12-month period and will confirm the expected rate of recruitment and data collection procedures. Phase 2 is the expansion of the pilot into the full definitive trial. A full trial report for the funder and peer-reviewed publications of the main results will be generated after the completion of this phase. All children aged 5-12 years inclusive presenting to the recruitment centres with Perthes’ disease of the hip are potentially eligible to take part. Upon presentation, children’s eligibility for the study will be assessed, if eligible, informed consent/assent will be sought. Following this baseline questionnaires will be completed. The children will then be split into two groups, using a research process called ‘randomisation’ to fairly allocate treatments: 1. Containment surgery (intervention): children will have an operation under a general anaesthetic. Whilst asleep, children randomised to active containment surgery will receive an operation on their hip. 2. Active (non-surgical) containment (comparator): children and families will receive an individual face-to-face best practice therapy session of up to 90 minutes with a trial-trained physiotherapist at the recruiting hospital/regional specialist centre. After treatment, the parents and/or participants will be asked to complete further questionnaires at 3, 6, 9, 12, 18, 24, 30 and 36 months after randomisation. Data will be collected primarily electronically with email and/or text message prompts. No additional visits or procedures are required as part of the study protocol at any follow-up time point. We will also invite patients to consent to data sharing with the Non-Arthroplasty Hip Registry, which will enable the long-term results of the treatments under investigation. A full trial report for the funder and peer-reviewed publications of the main results will be generated after the co
1. Radiographic evidence of Perthes’ disease 2. Radiographs demonstrate that the disease is in the initial, sclerotic or fragmentation stage 3. Aged 5 to 12 years inclusive 4. Willing and able to give informed assent/consent
1. There is evidence that the patient and/or parent would be unable to adhere to the study procedures or complete follow-up, such as insufficient comprehension 2. Child has undergone prior containment surgery on the affected hip (i.e. the hip to be randomised) 3. The child has previously been enrolled into the OP Non-STOP Study