Recruitment – the final push!

1. Funded by the MRC AUTOLOGOUS CHONDROCYTE TRANSPLANTATION/IMPLANTATION VERSUS EXISTING TREATMENTS ISCRCTN 48911177 NEWSLETTER June 2009 Issue 17 Recruitment – the final push! ACTIVE has had a long gestation period and an even longer period of labour but now for the delivery - June is upon us which means we only have seven months left to recruit over 100 patients. And we have even less time to convince the MRC that this will happen because another review is due in October. So, it’s time to pull out all the stops and make the most of this opportunity while the funding is still there to treat patients. 13 centres (listed below) have contributed this year. James Richardson here at Oswestry, Venkat Satish at Swindon and Tony Bhuller at Peterborough have been the best recruiters this year but there’s still time for others to catch up. Stanmore is now ready for referrals so if you have difficulties recruiting please consider sending your patients there! New centres The Nuffield Orthopaedic Centre, Oxford with PI Andy Price has been set up in record time to join ACTIVE so I eagerly await recruitment starting there. Exeter surgeons Peter Schranz and Vipul Mandalia are nearly set-up ready to start. At Sunderland Shaun O’Brien is in the process of joining. Trusts can claim extra support costs for ACTIVE from their Comprehensive Local Research Networks and this is helping the set-up process since R&D departments are keen to recruit into such studies. Wolverhampton finally got departmental agreement to join ACTIVE last week after waiting 3 years! Thanks to R&D and PI Mr Chugh for not giving up as it sounds like they have quite a few patients to recruit. Help at handWhat has happened to recruitment at Stockport, Hillingdon, St. Mary’s, Bath and York where everything should be in place for recruitment to happen? Throughout the trial I have generally been impressed with the amount of enthusiasm and effort centres have made and I appreciate the difficulties of finding eligible patients. However, there is always room for extra effort so please don’t hesitate to contact me at the Trial Office if you need any help with recruitment. I am happy to visit, and can give presentations to increase awareness about ACTIVE among your colleagues. Or perhaps staff need a refresher on how to recruit patients and put them through the trial? James Richardson is also happy to provide advice – just give him a ring (01691 404386) or email james.richardson@rjah.nhs.uk Number of patients randomised 29.05.09 Total: 285 PTO

2. UK-ICRS Meeting The UK-ICRS meeting took place in January at the RNOH, Stanmore. Led by Prof. Dave Marsh and Prof. George Bentley, this well-attended event generated much stimulating discussion between scientists and surgeons. We heard the latest from scientists working with stem cells; pondered on how best to measure outcomes; discussed strategies for further research and generally got carried away by all the exciting possibilities! One thing which was obvious though, ACTIVE has really helped create a collaborative network essential for undertaking large-scale research into cartilage repair. However, we need to complete ACTIVE by getting sufficient numbers to address the primary question (is cell grafting better than standard surgery?) if we want to get funding for more large-scale clinical research in the future. Follow-up of Patients We are pleased to say that data collection is going well and that most patients are completing their follow-up assessments. So far over 90 patients have completed 2-year follow-up; over 70 have completed 3-year follow-up and 17 have completed 4-year follow-up. Generally we are finding that patients who complete their assessments in the first 12 months also comply well with 2-4 year follow-up. So it seems the first 12 months is critical for encouraging patients to stay in the trial. Even if they appear to drop out we don’t like to give up - this week a patient returned a completed 2-year questionnaire having not done any of the assessments since 3-months follow-up. Input/return of completed data Samantha sends monthly reminders to let staff know when assessments are due. If patients fail to turn up or can’t be contacted then please remember to let Sam know so that she can help track the patient down before the assessment is overdue. It is also helpful if co-ordinators/assessors can input data or post data to us before the end of each quarter which means by the end of June for this quarter so that Sam can calculate what payments are due to you or your Trust. Patient newsletter It’s important to give a big thank-you to the patients who contribute their time and effort into ACTIVE. Having had failed conservative and surgical treatments many are truly motivated by the desire to improve treatments for others and may not realise just what an important contribution they each make to the overall success of the trial. One way to thank them is through newsletters and I am always looking for material to go in another patient newsletter – maybe one of your patients would like to share his/her experiences? We’ve had good feedback from the previous patient newsletters but sadly we struggle to get material for the next one. Thank you. Best wishes, Heather Smith ACTIVE Trial Manager Heatherj.smith@rjah.nhs.uk Tel: 01691 404142