The combined annual meeting of the AAOS Outcomes Special Interest Group and the HWB Foundation, San Diego, 2007

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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

Disclosure Research grants from: Biomet Inc Zimmer Inc Smith&Nephew Inc RSA Biomedical

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Acknowledgment All co-workers in Sweden & MGH Orthopedic Staff & The Orthopedic Surgeons in Sweden

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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.

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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.

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HWB Mission Statement

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• "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."

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

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

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Evidence based medicine

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• 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.

The Mission • To improve the outcome of total hip replacement.

• Quality control with focus on the procedure - not an implant register!

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

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The Internet has substantially facilitated feedback of information Available in English, German, Italian, French, Spanish and Swedish on:

www.jru.orthop.gu.se

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.

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Base line Data • Simple and easily available in the medical record.

• Physician compliance hardly needed to report the data.

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The Swedish THA Register 1979 - 2005

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• 256.298 primary THR • 24.476 revision THR

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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.

Logistics of the study

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• All departments in Sweden participate • The cohorts are the national production of primary and revision procedures.

• The Registry is owned by the profession.

Failure definitions in Registries

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• 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.

Epidemiology of THR in Sweden

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The Swedish THA Register 1979 - 2005 Type of fixation Cemented Uncemented Hybrids Reverse hybrid/unknown % 1979 - 2005 92.2

3.3

3.5

1.0

% 1992 - 2005 90.3

5.2

3.2

1.3

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90 88 86 84 82 80 100 98 96 94 92

Results of individual units All patients 1979-1991

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National average 1979-1991: (89,4%) Proportion of units: Above

44%

.

Below

19%

.

100 98 96 94 92 90 88 86 84 82 80

Results of individual units All patients 1992-2004

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National average 1992-2004: (92,5%) Proportion of units: Above

34%

.

Below

13%

.

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

Revision burden (%):

Revision THA/ the total sum of primary and revision THA

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Revision burden Revision burden Cemented Uncemented Hybrids All THA % 1979 - 2004 7.9

19.7

3.5

10.3

% 1992 - 2004

9.8

26.4

11.8

10.7

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Crude revision rate

(JBJS(Am) 87-A, July 2005, 1487-1497)

AAOS HM Feb 07 Country USA (≥65 yr old) Sweden(≥65 yr old) Years 1990-2002 1992-2000 Crude revision rate 16.9% 6.4%

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.

Crude revision rate

(JBJS(Am) 87-A, July 2005, 1487-1497)

AAOS HM Feb 07 Country USA (≥65 yr old) Sweden(≥65 yr old) Years 1990-2002 1992-2000 Crude revision rate 16.9% 6.4%

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.

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We need Registries as an instrument to monitor performance.

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In Sweden The Sulzer/Centerpulse experience

Type of implant Number implanted Inter-op cup 51 mm Inter-op cup 59 mm 18 12 Number revised 3 Crude revision rate @ 6 month 16,7% 2 16,7%

This problem was identified @ 8 month by the Register

In USA The Sulzer/Centerpulse experience

AAOS HM Feb 07 Type of implant Number implanted Inter-op cup 17,000 Number revised >3,000 Crude revision rate @ ? years 17,6%

This problem could have been identified @ 4-6 month by a Register

 Surgical technique  skill of the surgeon   Implant choice Introduction of new technology

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Research opportunities Cohort studies – “PhD projects”

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• Periprosthetic fractures • Primary infection • Re-revisions • Below 50

The Clinical Value Compass Patient Satisfaction

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Clinical Outcome Functional Health QoL Cost and Utility Batalden and Nelson, Dartmouth Medical School.

• Outcome that matters most – To patients • pain relief and satisfaction?

– To health care providers • Cost?

– To surgeons?

• Documentation, follow up and evidence/result??

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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.

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Registries in Sweden

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

Registries in Sweden • Cardiac • AMI, Bypass, pacemaker, “Heart surgery”, Stroke.

• Diabetes • PCP treatment, complications.

• Surgery • Vascular, Hernia,

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Effect of Registries in Sweden

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• 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.

World Progression of National Registries Before 1975

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1978 to 1987

Sweden, Finland, Norway

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1988 to 1997

Denmark, New Zealand

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1998 to 2003

Hungary, Australia, Canada, Romania

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2003 to Present AAOS HM Feb 07

Czech Republic, Turkey, Slovakia, Moldova, Austria, England, Wales, France, Germany(?), USA(?), Holland !

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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

Resurfacing for the young?

Revision rates by age and gender The Australian Register

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AAOS

Cumulative Revision in conventional

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Primary THR and Resurfacing Hip

The Australian Register 2005

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

Harris Joint Registry @ MGH (HJR)

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Outcome analyses engine @ MGH

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•IRB approved data repository at MGH. •Web based system collecting clinical and radiographic data semi automatically.

www.jointoutcomes.org/pv

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Harris Joint registry @ MGH interfaces to  OR scheduling (MOSAIC)  Anesthesia database (SATURN)  Longitudinal Medical Record (LMR)  Research Patient Data Registry (RPDR)  Radiology image repository (AMICAS)  Patient reported outcome

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Patient data, medical records and radiographs available in one data base for simultaneous review

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Patient reported outcome – Touch-screen entry for questionnaires • Patients can enter questionnaires by touch screen when they come for a clinic visit – Online Questionnaires • Patients can enter questionnaires through the Internet at home – Conventional paper forms

Minimize manual data entry

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• Less than 10 percent of the data will be entered manually

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Projects • The Shoulder, Spine, Sports and Tumor services @ MGH in different stages of incorporation.

• A state-wide register in Virginia in pilot-phase.

• Two Industry partners: – Monitoring clinical multicenter studies.

There should be

NO

alternatives to the principles of Evidence based Medicine

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Governments have already started to implement physician reimbursements based on

Evidence

Netherlands, Scotland, England, Canada Japan, Germany, Switzerland at least for some treatment methods for a few common disorders

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Evidence Based Medicine alternatives

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Eminence Based Medicine -used by senior colleagues with ”experience" - same mistakes again & again

Evidence Based Medicine alternatives

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Nervousness Based Medicine -fear of litigation stimulates over investigation and over treatment

Evidence Based Medicine alternatives

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Market Based Medicine -believing what the ads tell you

Evidence Based Medicine alternatives

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Profit Based Medicine -needs no explanation

Evidence Based Medicine

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• Therefore - in order to: - Globalize Evidence - Localize decisions - Improve information - Reward proper care • Report to your regional/national Registry

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 The register- work has reduced the revision  burden by 50%.

This is equivalent to a "saving" of 11.630 revisions the past ten years.

 Monetarily (direct costs) ~ US$ 139.560.000

 Annually US$ 14.000.000.

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Potential US “savings” Initiate a Register • For each percent lower (from 17.6%) the direct cost savings are estimated to $42.5 million - $112.6 million per year • A 10% reduction (to the Swedish level) could save $ 1 billion annually!

Kurtz et al: NHDS data, JBJS (Am), 2005

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Conclusion • For the healthcare providers the potential is large savings.

• For the patient optimal treatment modalities can be identified.

• For the professional community the research potential is obvious.

Take home message • 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.

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Thank You!

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Orthopaedic Biomechanics and Biomaterials Laboratory Massachusetts General Hospital