Extrait

Background and study aims Defects in the cartilage covering the bones of the knee (chondral defects) do not heal by themselves. A technique to treat cartilage defects called autologous chondrocyte implantation (ACI) was developed in Sweden and has been used on many patients in the UK and US. The ACI treatment involves two operations. At the first operation a small sample of healthy cartilage is taken from the knee to a laboratory for the cells to be grown for 3-5 weeks, and at the second operation the cells are injected into the knee defect. This treatment appears to have been successful in treating many patients but has not yet been tested in a formal study. The aim of this study is to compare ACI with conventional treatments for patients who have had a failed primary treatment for chondral defects in the knee. Who can participate? Patients who are still getting symptoms from the defect in their knee cartilage despite having surgical treatment for it in the past. What does the study involve? Participants receive a full knee assessment and complete questionnaires about their knee function and how it affects their quality of life. Participants are randomly allocated into one of two groups. One group has the ACI treatment and the other group receive the most appropriate alternative treatment agreed with their surgeon. Both groups receive the standard physiotherapy and rehabilitation programme that is best for the treatment they received, and attend a follow-up appointment 2 or 3 months after surgery and again at 6 months and at 1 year after surgery. On each occasion participants complete questionnaires and their knee function is assessed. Because we want to compare the long-term outcome of the treatments participants are asked to return to the clinic 3, 5 and 10 years later. We also contact participants by post, phone or e-mail on one occasion each year for 10 years so we can check on their progress. What are the possible benefits and risks of participating? We hope that whichever treatment participants have will help them. However, this cannot be guaranteed. The information we get from this study may help us to recommend the best course of action for patients in the future. For participants treated with ACI, in addition to the normal risks of knee surgery there is a small risk that they may experience an allergic reaction to a substance used in the cell transplantation. However, this reaction is very rare. Where is the study run from? The Robert Jones and Agnes Hunt Orthopaedic and District Hospital, NHS Trust (UK) When is the study starting and how long is it expected to run for? December 2004 to December 2021 Who is funding the study? Medical Research Council (UK) Who is the main contact? Prof James Richardson [email protected]

Critère d'inclusion

• Orthopaedics

Liens

• ictrp
• isrctn