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A utologous A utologous C hondrocyte T ransplantation/ I mplantation V ersus E xisting treatments ISCRCTN 48911177

A utologous A utologous C hondrocyte T ransplantation/ I mplantation V ersus E xisting treatments ISCRCTN 48911177. A multicentre orthopaedic surgical RCT involving over 25 UK centres and 2 Norwegian centres. Sponsored by Keele University

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A utologous A utologous C hondrocyte T ransplantation/ I mplantation V ersus E xisting treatments ISCRCTN 48911177

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  1. AutologousAutologousChondrocyteTransplantation/ImplantationVersusExisting treatmentsISCRCTN 48911177 A multicentre orthopaedic surgical RCT involving over 25 UK centres and 2 Norwegian centres Sponsored by Keele University Lead centre: Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Trust in collaboration with the University of Birmingham

  2. Overview • Aims of ACTIVE • ACTIVE Collaborators • Trial Design • Progress • Ongoing Challenges

  3. Primary Aim • Primary Aim • To determine whether ACI offers longer-term benefits than the “best alternative” non-ACI treatment for repairing chondral defects in the knee that remain symptomatic following previous treatment

  4. Secondary Aims • Secondary Aims: • To compare the use of periosteum with a manufactured membrane • To assess and compare the cost effectiveness of ACI vs non-ACI option and periosteum vs membrane

  5. Funding / Support • MRC grant for research costs • e.g. trial manager, local co-ordinators, assessors, travel & training, materials • DoH funds excess treatment costs • - to meet cost difference bt. ACI vs. non ACI option • NHS Service Support Costs are available • - for clinic resources per patient formally registered • - per follow-up outpatient visit at 6 mts, 3, 5, & 10 yrs • - for serology tests on control patients • Membrane donated by Geistlich • -any cell supplier can be used

  6. Collaborating Surgeons-UK & Norway Each centre has at least one surgeon and a study co-ordinator and independent assessor

  7. Surgeons’ Training Workshop

  8. Trial Design • Patients randomised to: • ACI/MACI or Surgeons’ best non-ACI choice • ACI arm randomised to (this is now optional) • periosteum or collagen membrane • patch patch

  9. Patient Eligibility • Isolated symptomatic chondral or osteochondral defect(s) in the knee • Meets the “uncertainty principle” • Previous failed treatment on same defect ≥ 6 mts earlier (may include arthroscopic washout) • Exclusions: • Bilateral defects, kissing lesions, defects >12cm2, total meniscectomy, patella malaligment, generalised osteoarthritis, patients with low probability of compliance with rehab & follow-up

  10. Summary of Data (March ’07 N=147) • 142 patients randomised • ACI Standard • Periosteum 36Microfracture 57 • Chondro-gide 35 Mosaicplasty 7 Debridement 5 • Drilling 2 • AMIC 1 95 men: 47 womenmean age 38 years old4 crossed over from ACI to standard2 withdrawn9 had additional procedures65 with 1 year follow-up

  11. Outcome Measures“robust & relevant data” • Primary Outcome Measure: • “Cessation of benefit” • – Combination of questionnaires & independent • blinded assessments over 10 years follow-up • Secondary Outcome Measures: • – Health Economics: QALYs estimated for each arm • from a societal perspective • – Cininnati Sports Activity Scale • – IKDC Subjective Knee Evaluation Form

  12. Independent Assessment

  13. Recruitment Progress (April ‘08) TotalPatients randomised = 208

  14. Further recruitment • Surgeons at RNOH, Stanmore have joined the trial and are ready to start • Will enable 480 patients to be recruited by end of 2009

  15. Further Information • Prof. James Richardson, Chief Investigator – tel: 01691 404386 • Talk to Heather Smith, Trial Manager • Heatherj.smith@rjah.nhs.uk Visit the website:www.active-trial.org.uk

  16. www.active-trial.org.uk

  17. Acknowledgements • Trial Steering Committee: • Prof. Neil Rushton (Orthopaedic Research Unit, Cambridge) • Dr Martin Landray (Clinical Trial Service Unit, Oxford) • Prof. Richard Gray (Birmingham Clinical Trials Unit) • Prof. James Richardson (RJAH Orthopaedic Hospital) • Prof. George Bentley (RNOH, Stanmore) • Prof. Marilyn James (Liverpool John Moores University) • Data Monitoring & Ethics Committee: • Prof. Hamish Simpson (Dept. Orthopaedics, Edinburgh Uni) • Dr Paresh Jobanputra (Dept. Rheumatology, B’ham Uni) • Dr Emma Hall (Institute of Cancer Research, Surrey)

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