Extrait

Background and study aims We are carrying out a study on patients who have sustained a fractured hip in order to compare different doses of antibiotics within the cement at the time of hip surgery. Our goal is to establish if adding a higher dose of antibiotics into the cement will reduce the rate of surgical site infection. We will look at a number of patient characteristic such as age, gender, rates of infection, timing of surgery, and other characteristics. The study's findings should help to improve the well being of patients with a fractured hip in the UK and to enhance the country's research base in orthopaedic infection. Who can participate? The study aims to recruit about 850 patients, aged above 18 years old, from the Northumbria NHS Trust (UK) who have sustained a fractured hip. What does the study involve? Patients will be randomly allocated to one of two groups. Randomisation, which is like a coin toss, will allocate the antibiotic cement given to the patient. Group 1 will receive low antibiotic dose cement (that is used in normal practice) and group 2 will receive high antibiotic dose cement (that is used in other forms of hip surgery in normal practice). Both groups will then have the same postoperative care and follow up. At the end of the study, we will compare the rates of surgical site infection between the groups. Patients will be given the same clinical care whether they are in group 1 or 2. What are the possible benefits and risks of participating? Risks include those normally associated with an operation and will be discussed at the time of the operation. The study may lead to a positive change in treatment for this operation in the NHS. There may be no differences between the two groups. Where is the study run from? The study has been set up by the Northumbria NHS Trust (UK). When is the study starting and how long is it expected to run for? Recruitment started in July 2008. Participants will be enrolled until the target number of 850 is reached. Who is funding the study? A small amount of educational funding has been supplied by Heraeus Medical (UK). Who is the main contact? Mr Mike Reed, [email protected] Mr Andrew Sprowson, [email protected]

Critère d'inclusion

• Fracture of neck of femur / Surgical site infection / orthopaedic

Liens

• ictrp
• isrctn