Extrait

Background and study aims The knee is the largest weight-bearing joint in the body, where the shin bone (tibia) and thigh bone (femur) meet. As we get older our bones naturally weaken, and so the elderly are particularly vulnerable to knee pain and injury. Every year, about 5,000-7,000 people over the age of 65 in the UK suffer from distal femur fractures (a fracture at the end of the thigh bone, just above the knee joint). In most cases, the main treatment offered is surgical fixation. This is an operation in which the broken pieces of bone are lined up, and held in place with wires, screws or metal plates. It is more effective than simply wearing a cast, as it ensures that the bones heal in the correct position. In order for this treatment to be work properly, patients need to rest and not put any weight on their leg. This can be very difficult, as in particularly elderly patients this process can be very slow due to their weakened bones (osteopenia). An alternative treatment is distal femoral replacement (DFR) surgery. This operation involves removing the section of broken bone and replacing it with man-made implant made from metal or plastic (prosthesis). It has the advantage of a very rapid recovery, and patients are able to put weight on their leg again almost immediately. This type of operation is more common in younger people who have suffered a serious injury, such as a car accident, and so more research is needed to find out if it is a good alternative to surgical fixation in the elderly. The aim of this study is to look at the effects of having DFR surgery or surgical fixation on the recovery of elderly patients with a distal femur fracture. Who can participate? Adults over 65 years of age with a distal femur fracture, who are suitable for a DFR surgery. What does the study involve? Participants are randomly allocated to one of two groups. Participants in the first group receive distal femoral replacement surgery. Participants in the second group have an operation which involves surgical fixation of the fracture. The length of time that the participants have to stay in hospital after their surgery is then recorded. Information about the patients (health related questionnaires, complications, length of hospital stay and X-ray pictures) is collected before surgical treatment and at 6 weeks, 6 months and 9 months after their surgery in order to compare the effectiveness of the two treatments. What are the possible benefits and risks of participating? Participants will benefit from good continuity of care, as they will see a dedicated consultant and research nurse throughout their involvement in the study. Risks of participating include the general risks of undergoing surgery, and being sedated with general anaesthetic. Where is the study run from? Addenbrookes Hospital and six other NHS hospitals in England (UK) When is the study starting and how long is it expected to run for? October 2015 to April 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Miss Justyna Romanik

Critère d'inclusion

• Topic: Injuries and emergencies, Musculoskeletal disorders, Ageing; Subtopic: Injuries and Emergencies (all Subtopics), Musculoskeletal (all Subtopics), Ageing; Disease: Injuries and Emergencies, Musculoskeletal, All Ageing

Liens

• isrctn
• ictrp