Presentation on theme: "Protocol amendments Good news! After a lengthy process the MRC and ethics have approved the following changes to the protocol: Extension An extension to."— Presentation transcript:
Protocol amendments Good news! After a lengthy process the MRC and ethics have approved the following changes to the protocol: Extension An extension to the recruitment period of up to the end of 2009 to recruit at least 480 patients. Patella lesions Patella lesions can now be treated in the trial. OCDs Osteochondral defects can now be treated in the trial. Any OCDs involving more than 3 mm of bone loss must be grafted but the type and timing of bone graft is down to surgeons’ choice since there is a lack of evidence to support any one particular method. Matrix-ACI option As you know MACI is already a cell grafting option in the trial. A further matrix version of ACI called Chondron in which the cells are suspended in a gel at the time of surgery is now an option as a subrandomisation against MACI. Surgeons choosing this option must still select a standard treatment as part of the main randomisation. Funded by the MRC AUTOLOGOUS CHONDROCYTE TRANSPLANTATION/IMPLANTATION VERSUS EXISTING TREATMENTS ISCRCTN NEWSLETTER April 2008 Issue 14 Number of patients randomised Total: 208 PTO Recruitment / new centres Thanks to everyone who has contributed to getting us past the 200 mark for recruitment. Just another 280 to go! Fortunately we anticipate a large increase in the rate of recruitment now that Stanmore is ready to start. Fairfield General Hospital in Bury is our latest centre to begin recruitment and further centres are being set up. ACTIVE Workshop A workshop for new surgeons is being planned to take place at Oswestry on either the 3 rd or 10 th June (or both days depending on numbers). If you are new to the trial or know of colleagues who would like to attend please contact Heather. New co-ordinators and assessors are also welcome. The workshop involves talks on surgical techniques and the ACTIVE protocol; observing a 2 nd stage ACI in theatre with Prof Richardson; and a hands-on practice of cell-grafting techniques using cow stifle joints. New forms Each co-ordinator will be sent a pack of the latest version (v 3.1) of the Patient Information Leaflet. A further version (3.2) is to be used by Stanmore and any other centres who decide to use Chondron. New Patient Entry Forms and Treatment Records will be sent out shortly to include the above protocol changes. Please continue using your existing forms until the new ones arrive. If you are entering patients with an OCD or patella lesion please notify Heather first.
Health economics An important aspect of ACTIVE is to evaluate the cost effectiveness of ACI versus standard treatments. We are fortunate that recently Prof. Marilyn James and Liz Stokes from Liverpool John Moores University have taken on the role of Health Economists for the trial. As a result we have introduced some changes to the collection of resource usage: 1.New Resource Usage forms have been sent out to every centre. These are to be completed by patients at 2/3, 6 & 12 months, then annually. It is no longer collected at pre-op. We will notify you when the database is ready to accept these new forms. In the meantime please send copies of completed forms to the trial office as a backup. 2.Co-ordinators will be sent a new form and asked to complete further details about hospital resource usage using hospital notes (e.g. length of stay in hospital; additional procedures). This new form is currently being piloted at Oswestry but will be finalised and sent out soon. UK-ICRS Meeting A UK-ICRS conference is planned for the Autumn, to take place at Stanmore, led by Prof. Dave Marsh and Prof. George Bentley – date to be confirmed. The latest version of the protocol can be downloaded from the website under “study documents” along with a summary of all the protocol amendments. A hard copy will be sent to every centre in due course. Best wishes, Heather Smith ACTIVE Trial Manager Tel: Happy at work in St. Olavs Hospital, Trondheim – from left to right: Bente Johansen (co-ordinator) Ingrid Solhjem (assessor) and Berit Wenaas (admin assistant) looking very organised with their ACTIVE files