The relative value of “all-inclusive” registries vs.

1. The combined annual meeting of the AAOS Outcomes Special Interest Group and the HWB Foundation, San Diego,2007 The relative value of “all-inclusive” registries vs. Focused prospective clinical research of all designs - not just RCT's Henrik Malchau Professor, MD, PhD Orthopaedic Biomechanics and Biomaterials Laboratory Massachusetts General Hospital

2. DisclosureResearch grants from:Biomet IncZimmer IncSmith&Nephew IncRSA Biomedical

3. AcknowledgmentAll co-workers in Sweden&MGH Orthopedic Staff & The Orthopedic Surgeons in Sweden

4. The Presentation • Introduction. • How the Register has changed the results of THR surgery in Sweden. • Registries in Sweden. • The Harris Joint Register @MGH. • Cost benefit of Registries • Conclusions.

5. Conclusion • In the (not too far) future Registries will be the main source of scientific information for decision support for both health administrators, physicians and patients in the field of reconstructive joint surgery.

6. HWB Mission Statement • "The mission of the HWB foundation is to find methods to routinely collect well-specified, structured and privacy-protected clinical data from reliable sources and make that data, in quantities of statistical significance, available in the public domain where it may be interpreted from all points of view."

7. We are all obliged to build the clinical treatment on evidence based principles

8. Nothing ruins a good result as decent and long-term follow-up!

9. Evidence based medicine • Evidence based medicine and patient-derived outcomes assessment movements entered the scene in the 1980s and 1990s. • In the late 80s and early 90s critical research suggested that 40% of surgical procedures might be inappropriate and up to 85% of common medical treatments were not adequate validated.

10. The Mission • To improve the outcome of total hip replacement. • Quality control with focus on the procedure - not an implant register!

11. The Hypothesis • Feed-back of analysed data stimulates the participating clinics to reflect and improve in accordance with the principle of the good example.

12. The Internet has substantially facilitated feedback of information Available in English, German, Italian, French, Spanish and Swedish on: www.jru.orthop.gu.se

13. Base line (level I) Data • ID number (links to coming reoperations) • Gender, Age • Diagnose (ICD 10) • Implant details based on catalog numbers (scroll menu or barcode scanning). • Type of cement. • Type of incision & surgical technique.

14. Base line Data • Simple and easily available in the medical record. • Physician compliance hardly needed to report the data.

15. The Swedish THA Register1979 - 2005 • 256.298 primary THR • 24.476 revision THR

16. Outcome results • The Swedish experience is based on all performance in the country. • In USA 50% of the primary THR procedures are done by surgeons performing < 10 THR's annually. • The scientific results are typically presented from centers of excellence with dedicated, high volume surgeons (HHS, Mayo, MGH) – often with innovators in key roles.

17. Logistics of the study • All departments in Sweden participate • The cohorts are the national production of primary and revision procedures. • The Registry is owned by the profession.

18. Failure definitions in Registries • Most commonly used is revision. • Patient satisfaction and patient reported outcome used in Sweden since 2002. • Radiographic outcome based on large cohorts soon possible with modern image analysis tools.

19. Epidemiology of THR in Sweden

20. The Swedish THA Register1979 - 2005

21. Results of individual units All patients 1979-1991 National average 1979-1991: (89,4%) Proportion of units: Above 44%. Below 19%.

22. Results of individual unitsAll patients 1992-2004 National average 1992-2004: (92,5%) Proportion of units: Above 34%. Below 13%.

23. The “National result” improved to 92.5% survival @ 12 years -all comers and cement!!!

24. Revision burden (%): Revision THA/ the total sum of primary and revision THA

25. Revision burden

26. Crude revision rate (JBJS(Am) 87-A, July 2005, 1487-1497) Prevalence of Primary and Revision Total Hip and Knee Arthroplasty in the United States From 1990 Through 2002 Kurtz S, Mowat F, Ong K,Chan N, Lau E, and Halpern M.

27. Crude revision rate (JBJS(Am) 87-A, July 2005, 1487-1497) Prevalence of Primary and Revision Total Hip and Knee Arthroplasty in the United States From 1990 Through 2002 Kurtz S, Mowat F, Ong K,Chan N, Lau E, and Halpern M.

28. We need Registries as an instrument to monitor performance.

29. In SwedenThe Sulzer/Centerpulse experience This problem was identified @ 8 month by the Register

30. In USAThe Sulzer/Centerpulse experience This problem could have been identified @ 4-6 month by a Register

32. Research opportunitiesCohort studies – “PhD projects” • Periprosthetic fractures • Primary infection • Re-revisions • Below 50

33. The Clinical Value Compass Patient Satisfaction Functional Health QoL Clinical Outcome Cost and Utility Batalden and Nelson, Dartmouth Medical School.

34. Outcome that matters most • To patients • pain relief and satisfaction? • To health care providers • Cost? • To surgeons? • Documentation, follow up and evidence/result??

35. The Clinical Value Compass Hypothesis • The Registry concept with added patient reported outcome data can potentially improve the overall process and all dimensions in the “compass”. • We can even perform cost-utility studies based on large cohorts.

36. Registries in Sweden • Based on the experience from the Hip Register more than 50 registries has been established in the past 15 years

37. Registries in Sweden • Cardiac • AMI, Bypass, pacemaker, “Heart surgery”, Stroke. • Diabetes • PCP treatment, complications. • Surgery • Vascular, Hernia,

38. Effect of Registries in Sweden • Decreased mortality after AMI and less variance among the units. • 50% reduction in reoperations after surgery for hernia. • Decreased mortality and less morbidity after stroke. • Significant reduction of diabetes complications.

39. World Progression of National Registries Before 1975

40. 1978 to 1987 Sweden, Finland, Norway

41. 1988 to 1997 Denmark, New Zealand

42. 1998 to 2003 Hungary, Australia, Canada, Romania

43. 2003 to Present Czech Republic, Turkey, Slovakia, Moldova, Austria, England, Wales, France, Germany(?), USA(?), Holland !

44. Resurfacing THA “New” Procedure with Unanswered Questions Short Term – Intermediate F/U Studies More Difficult Surgical Procedures Higher Complication Rate vs. THA Patient selection issues

45. Resurfacing for the young?Revision rates by age and gender The Australian Register

46. Cumulative Revision in conventional Primary THR and Resurfacing Hip The Australian Register 2005

47. Can we obtain the needed statistical power in a conventional longitudinal study??

48. Harris Joint Registry @ MGH (HJR)

49. Outcome analyses engine @ MGH • IRB approved data repository at MGH. • Web based system collecting clinical • and radiographic data semi automatically.

50. www.jointoutcomes.org/pv