1 / 81

Multi-centre trials in Orthopaedic Oncology: Dream or Reality?

Multi-centre trials in Orthopaedic Oncology: Dream or Reality?. Michelle Ghert, MD, FRCSC Associate Professor Department of Surgery McMaster University. 22 year-old male with sarcoma right femur. Deep infection in total joints. Approximately 1% risk

lotte
Télécharger la présentation

Multi-centre trials in Orthopaedic Oncology: Dream or Reality?

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Multi-centre trials in Orthopaedic Oncology:Dream or Reality? Michelle Ghert, MD, FRCSC Associate Professor Department of Surgery McMaster University

  2. 22 year-old male with sarcoma right femur

  3. Deep infection in total joints • Approximately 1% risk • AAOS guidelines: 24 hours of gram positive coverage with pre-operative dosing

  4. Tumour prosthesis: higher risk • Patients are myelo-depleted due to chemotherapy • Surgeries are long and the wound is open for several hours • Large foreign body • Large dead space • Loss of protective soft-tissue coverage

  5. What is the magnitude of the problem?

  6. Systematic Review • Deep infection rate 9.5% (95% confidence interval: 8.1% to 11%) • Comparison to primary arthroplasty: 1%

  7. Systematic Review Conclusions • The risk for deep infection following tumour prosthesis is high, X10 that of total joints • Antibiotic regimens vary from publication to publication • There no published guidelines to direct management

  8. What antibiotic regimens do we use?

  9. Duration of antibiotics

  10. Results

  11. PARITY Survey conclusions • Practice patterns vary considerably with respect to antibiotic regimen, dosages and duration • Majority of surgeons are willing to change practice • Overwhelming support for a multi-centre clinical trial

  12. Hierarchy of Evidence Randomized Trials Less Bias Level 1 Prospective Cohort Studies Level 2 Level 3 Case Control Studies Level 4 Retrospective Case Series Opinion Level 5 More Bias

  13. RCTs in Orthopaedic Oncology • Orthopaedic Oncology multi-center randomized controlled trials: • Radiation Oncology: one trial, 150 patients • Medical Oncology: 72, methodologically poor • Surgical Oncology: NONE • There is a lot of talk about RCTs in Orthopaedic Oncology, but no doing

  14. Why do we need multi-centre trials?

  15. Tibial Shaft Fractures (SPRINT)

  16. Multicenter RCT’s • Advantages • Level 1 Evidence • more centers = More Patients • shorter study recruitment time • increased generalizability of results • collaboration between centers, countries and continents

  17. Multicenter RCT’s • Disadvantages • They are Hard to Do • Complex organization • Very Expensive

  18. But not impossible…. • Cardiology • OASIS-6 RCT • 13000 pts (JAMA, 2006) • 447 hospitals • 41 countries

  19. But not impossible…. • Intensive Care Medicine • PROTECT (DVT prophylaxis) • Canadian Critical Care Trials Group • 4000 pts • North America/Australia

  20. But not impossible… • Neonatal Medicine • Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. • N=910 infants • 32 centers • NA, Austalia, NZ, China • JAMA. 2003

  21. Has it been done in Orthopaedic Surgery? • SPRINT Trial (Tibial Shaft Fractures) • 1339 patients recruited, 95% F/U

  22. Challenges in Surgical Trials

  23. Can Surgeons be Blinded?

  24. Who can be blinded?Patient and outcome assessors

  25. Expertise Bias

  26. Expertise Bias • Surgeons tend to stick to procedures that they are good at • Difficult to convince surgeons to develop new techniques • Solution: patients are allocated to provider, not procedure

  27. But can it be done anyways?

  28. Center for Evidence-Based Orthopaedics

  29. SPRINT trial: 1339 patients, 95% follow-up • FLOW trial: 2200 patients recruited, target 2200 • FAITH trial: 900 patients, target 1000 • TRUST trial: 600 patients, target 1000 • HEALTH trial: 350 patients, target 1400 • INORMUS and PRAISE prospective studies: 9000 patients • All trials are funded by NIH/CIHR • 150 centers around the world

More Related