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.

RESEARCH QUESTION: What is the clinical and cost-effectiveness of containment surgery compared with best conservative care in the treatment of Perthes’ disease of the hip? BACKGROUND: Perthes’ Disease is an idiopathic necrosis of the developing femoral head. It is a major precipitant of premature osteoarthritis of the hip, and frequently necessitates hip replacement in early adulthood. It is one of the most common, and perhaps the most poorly understood disorders presenting to children’s orthopaedic surgeons; affecting approximately 1:1,200 children during their lifetime. It predominantly affects white boys from northern England and is strongly associated with socioeconomic deprivation. Nationally and internationally, there are widespread differences in the treatment of this disease. These vary significantly from surgery involving femoral and/or pelvic osteotomies, to physiotherapy or simple observation. There is no high quality evidence to guide treatment. The uncertainty has prompted members of the British Society of Children’s Orthopaedic Surgery to make this a top research priority. METHODS: We propose a multi-centre prospective randomised superiority trial of containment surgery versus best conservative care for children affected by Perthes’ disease aged 5 years and above. We will use well-established networks of children’s orthopaedic surgeons engaged in research; many of whom have recently contributed to a preceding study in this disease area. The primary outcome is the Patient Reported Outcomes Measurement Information System Mobility Score for Children (PROMIS Mobility) at 3 years. Secondary outcomes include quality of life, acceptability and outcomes from the Perthes' disease Core Outcome Set. The proposed project is a two-phased study. An internal pilot will confirm the expected rate of recruitment, and will take place at 15 centres over 12 months. The pilot will confirm the number of eligible and recruited patients in centres and optimise data collection procedures. The pilot will seek to recruit >0.35 patients/ month/ centre, and has clear stop/go criteria. The main trial will recruit from approximately 28 centres over an additional 18 months.. A randomisation sequence, using a minimisation algorithm with stratification factors: age group (5-7 years, 8-16 years), sex and current collapse ( 50%) will be produced by the trial statistician. Patients will be randomly allocated (1:1) to interventions. Outcomes will be collected at 6, 12, 18, 24, 30 and 36 months. The primary outcome time-point is at 36 months (3 years). Electronic follow-up will be administered centrally and all digital materials will be optimized for mobile telephones; which is the most widely accessible digital format that 99% families have access to. Consent will be sought from participants to allow potential future follow up through efficient means using linkage to routine healthcare databases, such as the hospital episode statistics, national joint registry of England and Wales, and similar registries in Scotland and Northern Ireland. TIME FOR DELIVERY: The study will last 80months, including 30 months recruitment & 36months follow-up. DISSEMINATION: In additional to traditional dissemination (i.e. journal articles), we will prepare a multimodal dissemination package to engage clinicians and families to maximise the impact of the results and facilitate the implementation of the findings (i.e. see our prior work www.FORCEstudy.org)