Extrait

Background and study aims Developmental dysplasia of the hip, also known as DDH, is the medical term used to describe “looseness and underdevelopment” of the hip joint. It occurs when the ball at the top end of the thigh bone does not sit properly within the hip socket. DDH affects thousands of children each year, and ranges from mild hip instability to complete dislocation of the hip. There is no single cause but children born in the breech position and those with a family history of DDH are most at risk. The most effective treatment for children with DDH is carried out in the first 3 months of life with the application of a harness or splint which is applied for a period of weeks. Unfortunately, not all children respond to this treatment and some with this condition are not diagnosed until much later than 3 months. These children are therefore treated differently and need a hip plaster cast with or without the need for an operation beforehand. If an operation is required, this means having a general anaesthetic and a short stay in hospital, in addition to the plaster cast. Doctors are not certain whether it is best to treat straight away or wait until later, usually nearer 12 months of age. As we do not know whether it is better to treat earlier or later, we need to compare the two groups of children in this study. This study plans to find out what is the best time to treat these children. Who can participate? Children aged 3 to 13 months diagnosed with hip displacement requiring an operation. What does the study involve? Children will be randomly allocated to one of two treatments. One groups will receive the treatment earlier (within two weeks of allocating) and the other group receives it later (no later than 13 months). By taking part in this study the child’s hips will be monitored regularly as normal during the study. The child will have regular routine x-rays and examinations and parents will be asked some extra questions about how they feel about the treatment they and the child have received. The type of treatment that the child receives will not change from the normal treatment done at hospital, only the timing of the treatment may be different as it will be chosen randomly. Everything that is normally done for this group of children as part of their treatment will remain the same. Parents will also be asked to complete a diary and some questionnaires during the course of the study and all information collected during the study will be completely confidential. What are the possible benefits and risks of participating? There are no benefits to a child taking part in this study as the treatment received will be what is normally given to children with this condition. However, by taking part in this study you will be providing valuable information about your personal experience of DDH and this could influence how best to treat children with DDH in the future. There are no real disadvantages in taking part and there are no additional risks. There are, however, the normal potential risks associated with surgery, should a child require surgery as part of their treatment. The child’s doctor will be able to address any concerns parents may have about their child having hip surgery and parents should ask as many questions as needed to put their mind at rest. Parents can also access further information on surgery for hip dysplasia via the ‘steps’ website ( http://www.steps-charity.org.uk /) or via the International Hip Dysplasia Institute website ( http://hipdysplasia.org /). Where is the study run from? The study is run from the following sites in the UK: University Hospital Southampton, Royal National Orthopaedic Hospital (Stanmore), Queens Medical Centre - Nottingham, Royal Victoria Infirmary - Newcastle upon Tyne, Bristol Royal Hospital for Children, The Royal London Hospital - Barts, Great Ormond Street Hospital, Royal Blackburn Hospital - East Lancashire, Sunderland Royal Hospital , Coventry & Warwickshire NHS Trust, Nuffield Orthopaedic Centre, Oxford, Sheffield Children’s Hospital, Royal Devon and Exeter – Princess Elizabeth Orthopaedic Centre, Leeds General Infirmary, Leicester Royal Infirmary, Aldery Hey, Plymouth Derriford Hospital. When is the study starting and how long is it expected to run for? The study will start in September 2014 and will run until June 2024. Who is funding the study? National Institute for Health Research (NIHR), UK. Who is the main contact? Mrs Louisa Little [email protected]

Critère d'inclusion

• Topic: Children, surgery, orthopaedics; Subtopic: All Diagnoses; Disease: All Diseases

Liens

• ictrp
• isrctn