Extrait

Background and study aims Osteoarthritis of the knee is a common condition that affects ~25% of the population over the age of 50. It occurs when there is damage to the knee joints that the body isn’t able to repair. The exact cause is not known, but there are a number of factors thought to increase the risk of developing the condition. Symptoms include pain while walking (particularly when climbing the stairs or walking uphill), knees ‘giving way’ or difficulties in straightening the legs. The most common treatment option for osteoarthritis of the knee is a knee replacement. There are currently two main forms of knee replacement used, total knee replacement and unicompartmental knee replacement (used when only one side of the knee joint is damaged). Total knee replacement involves replacing both sides of the knee joint with metal implants separated by a plastic spacer or bearing. Unicompartmental knee replacement involves replacing only the side of the knee joint that is damaged, with smaller metal implants used to replace that side. Total knee replacement successfully provides pain relief in around 80% of cases, but the knee joint never feels ‘normal’ and patients often find that they can’t do more physically demanding activities. Several studies have shown that 10-20% of patients are dissatisfied with the results of their total knee replacement surgery. In comparison, patients who undergo unicompartmental knee replacement surgery tend to have more normal walking patterns and a more normal feeling knee with better function than if they had had a total knee replacement. However, it is estimated that only 25% of patients have osteoarthritis on only one side of the knee and are therefore eligible for the surgery and, as it’s a complex procedure, many surgeons do not offer it as an option. Recently robotic assistive technology has been introduced to help surgeons perform unicompartmental knee replacement. The team at Glasgow Royal Infirmary have used this technology and found that implants are placed more accurately using it and that patients recover from surgery faster and, at least initially, have better outcomes. A natural extension of the unicompartmental knee replacement technique would be to use two unicompartmental knee replacements implanted at the same time on either side of the same knee joint – this is called bi-unicompartmental knee replacement. This technique would allow surgeons to leave knee ligaments intact and replace only the damaged parts of the joint rather than removing the whole knee joint as occurs with total knee replacement. We believe that this surgical option would allow patients to walk more normally (a normal gait) and give them a significantly more ‘normal’ feeling and acting knee than with a conventional total knee replacement. The purpose of the study is to determine if robotically assisted bi-unicompartmental knee replacement allows patients to walk with a more normal gait than is achieved with a traditional total knee replacement. Who can participate? Patients that have osteoarthritis on both sides of the knee but have intact knee ligaments. What does the study involve? Patents are randomly placed into one of two groups. Those in group one undergo standard total knee replacement surgery while those in group two undergo robotically assisted bi-unicompartmental knee replacement. The progress of each patient will then be followed up after 3 months, and then after 1, 2, 5 and, finally, ten years, after surgery. What are the possible benefits and risks of participating? Robotic assisted bi-unicompartmental knee replacement is a new technique and only around 20 cases have been undertaken using this technology worldwide. We therefore cannot tell how well this surgery will perform in the long term. The most significant risks for patients undergoing knee replacement surgery are infection within the new joint and in the longer term wearing out of the implant. We do not think that the risk of infection will be any higher for patients who receive robotic assisted bi-unicompartmental knee replacement. We cannot predict how long robotic bi-unicompartmental knee replacement knee implants will last as the technique is too new. In addition, patients that take part in this study will have at least one CT scan of their knee (some patients will have two CT scans). This will involve additional exposure to X-rays. Where is the study run from? Glasgow Royal Infirmary, Scotland, UK When is the study starting and how long is it expected to run for? August 2014 to August 2027 Who is funding the study? Medical Research Council (UK) Who is the main contact? Dr Iain Anthony [email protected]

Critère d'inclusion

• Osteoarthritis of the knee

Liens

• ictrp
• isrctn