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AdvaMedAdvanced Medical Technology Associat ion
The effectiveness and value of total joint replacement in the treatment of osteoarthritis
27 Million AmericansSuffer from Osteoarthritis
What is osteoarthritis?• Osteoarthritis (OA) is a progressive, destructive disease of the major joints for
which there is no cure.1
• 27 million Americans suffer from OA.2
• Osteoarthritis is one of the leading causes of disability and functional limitation in the United States.3,4
% of disabled adults reporting each disability
Leading causes of disability among U.S. non-institutionalized adults
Deafness/Hearing
Diabetes
Mental/Emotional
Lung/Respiratory
HeartTrouble
Back orSpine
Arthritis orRheumatism 19%
16.8%6.6%
4.9%4.9%
4.5%4.2%
MMWR, CDC, May 1, 2009
Healthy Hip Arthritic Hip
1
• Total joint replacement is when arthritic or damaged bone is removed and replaced with an artificial joint to restore mobility and relieve pain.5
• The most commonly performed total joint replacement surgeries are for the hip and knee.6
• Total joint replacement “remains the definitive treatment for advanced, symptomatic joint destruction regardless of the underlying cause.”7
What is total joint replacement?
Note: Joint replacements are each cleared or approved for use in specific disease states and/or injuries and may not be appropriate for certain underlying causes of pain and mobility.
Knee ReplacementArthritic Knee
2
• Bone and joint disorders, including OA, account for 440 million lost work days and $110 billion in lost wages each year – more than any other medical condition.8
• Workers with OA are one-third less productive than non-afflicted workers.9
Osteoarthritis drives up employer and health costs
440million
Musculoskeletal
2005 Data
Lost work days by selected condition
240million 215
millionCirculatory Respiratory
Burden of Musculoskeletal Disease, U.S. Bone and Joint Initiative, 2011
Bone and joint disorders account for nearly 440 million lost work days per year - more than any other medical condition
Bone and joint disorders drain $110 billion per year in lost wages
Burden of Musculoskeletal Disease, U.S. Bone and Joint Initiative, 2011.
1996-98 1997-99 1998-2000 1999-2001 2000-02 2001-03
Lost wages due to musculoskeletal disorders, Americans, age 18-64 (in $billions)
2002-04$45.10
$61.50 $61.70 $61.60 $65.30
$83.90
$110.50
3
• Patients with walking impairments from OA are reported to run a risk of early death that is 1.48 times higher than the general population. Risk factors for mortality include “a history of diabetes, cardiovascular disease, or cancer and increased walking disability.”10
• 40% of men and 57% of women with knee OA are physically inactive.11
• The CDC reports that 47% of adults with arthritis in the United States have one or more comorbidities.
• Common comorbidities and their rates in adults with arthritis include: • Heart disease, 24% • Chronic respiratory conditions, 19%• Diabetes, 16%• Stroke, 7%12
Osteoarthritis is associated with other disabilities and chronic conditions
Haz
ard
ratio
(ref
eren
ce=1
)
General Population (reference)
OA sufferers with and without a walking disability: risk of death among patients from 1994-95 through February, 2009
1OA Sufferers with a walking disability
OA sufferers with a walking disability show a higher risk of death when compared to the general population
1.48Nuesch E, et al., “All, cause and disease specific mortality in patients
with knee or hip osteoarthritis: population based cohort study,”BMJ 2011; 342:d1165doi:10.1136/bmj.d1165
4
Percent of arthritis su�erers with each co-morbidity
Co-morbid conditions among arthritis sufferers
1+ comorbodity Heart disease Chronic respiratory conditions
Diabetes Stroke
Centers for Disease Control
47% 24% 19%
16% 7%
Knee osteoarthritis sufferers show high levels of inactivity
Inactive OA Su�erers
Dunlop, et al., Arthritis & Rheumatism, November, 2011
Perc
ent o
f phy
sica
lly in
activ
e os
teoa
rthr
itis
su�e
rers
40% 57%
5
Total joint replacement helps patients return to work and their lives• Total joint replacement has proven successful in returning patients to their jobs. • Studies have shown that 90% of working patients return to work after total hip
replacement (THA) and 98% of working patients return to work following total knee replacement (TKA).13, 14
90%
Return to Work - THA
Return-to-work among working-age patients
98%
Return to Work - TKA
Most working patients return to work after total joint replacement
Nunley RM, et al., “Do Patients Return to Work After Hip Arthroplasty Surgery,” J. Arthroplasty Vol. 26 No. 6 Suppl. 1, 2011.
Lombardi AV, et al., “Do Patients Return to Work after Total Knee Arthroplasty,” Clinical Orthopaedics and Related Research, June 13, 2013
6
• Patients have shown 56% improvement in function scores after total knee replacement, and 79% improvement after total hip replacement.15
How can total joint replacement help patients?
79%
IMPR
OVE
MEN
T AF
TER
SURG
ERY
Functional Improvement after THA
% Improvement in Physical Function Score
Functional Improvement after TKA
56%Cushner F, et al., “Complications and Functional Outcomes After Total Hip Arthroplasty and Total Knee
Arthroplasty: Results From the Global Orthopaedic Registry (GLORY),” Am. J. Orthop 2010 Sep; 39 (9 Suppl): 22-8.
Patients’ physical function shown to improve 56% after total knee replacement, 79% after total hip replacement
7
“Improved physical function is associated with higher likelihood of employment, higher household income and fewer missed work days for those who are employed, and reduced likelihood of receiving supplemental security income for disability.”16
--Dall, et al., JBJS (Am), August 21, 2013
• Medicare patients receiving total hip and knee replacement show nearly half the risk of death after seven years compared to OA patients not receiving total joint replacement.17,18
Total joint replacement contributes to improved general health
TOTAL HIP ARTHROPLASTY
TOTAL KNEE ARTHROPLASTY
TKA
TKA No TKA(Reference
cohort)
THA
THA
HAZ
ARD
RAT
IO (r
efer
ence
=1)
HAZ
ARD
RAT
IO (r
efer
ence
=1)
No THA(Reference
cohort)
1
.53 .52
1
Hazard ratio of mortality at 7 years
Dramatically reduced risk of death following total knee and total hip replacement
Lovald ST, et al., “Mortality, Cost and Health Outcomes of Total Knee Arthroplasty in Medicare Patients,” Journal of Arthroplasty, November 2012
“Mortality, Cost, and Downstream Disease of Total Hip Arthroplasty Patients in the Medicare Population,” Journal of Arthroplasty, May 2013
8
• Joint replacement implants have shown excellent long-term durability, with numerous registries reporting that the original joint replacements are still present in over 90% of patients at 7-11 years, depending on the registry.19, 20
Total joint replacements show excellent long-term durability
Registry data Procedure Survivorship/ revision
Follow-‐up
England and Wales, 2012
Primary hip replacement
96.1% not revised 8 years
England and Wales, 2012
Primary knee replacement
96.3% not revised 8 years
Australia, 2012 Primary hip replacement
90-‐97.8% not revised
10 years
Australia, 2012 Primary knee replacement
93.9% not revised 11 years
Swedish Hip, 2011 Primary hip replacement
95% survivorship 10 years
Swedish Knee, 2010
Primary cemented knee replacement
~4% risk of revision
10 years
Kaiser Permanente Registry, U.S.
Primary knee replacement
98.3% not revised 7 years
Kaiser Permanente Registry, U.S., 2010
Primary hip replacement
98.1% not revised 7 years
9
• Total knee replacement surgery generates a net societal savings of approximately $19,000 per patient lifetime, due to reduced disability costs and improved productivity.21
• In 2009 alone, savings in the U.S. were an estimated $12 billion.
Total knee replacement surgery is cost-saving
Direct cost and societal savings per patient lifetime, total knee replacement
Direct Cost
Total Societal Savings
Net savings
per patient lifetime
$(20,635)
$39,565
$18,930
Ruiz, et al., JBJS Am, August 21, 2013
10
• In 2011, it was reported that only 13% of patients with an appropriate indication for total knee replacement actually undergo the procedure.22
• There is “widespread consensus” that fewer than 25% of people for whom total hip replacement is clinically appropriate actually undergo the procedure.23
• This is consistent with earlier reports that only about 9%-34% of patients with hip and knee OA of sufficient severity to warrant joint replacement were willing to have the procedure.24-27
• A New England Journal of Medicine study reported that, although women are more likely to report hip or knee joint problems, they are less often put on a joint replacement waiting list and less likely than men to undergo joint replacement.28
Total joint replacement is under-utilized
18,000,000
4,100,000
500,000
SymptomaticOA
Surgical Candidates
Knee ReplacementPatients
2008 data
London NJ, et al., “Clinical and economic consequences of the treatment gap in knee osteoarthritis management,” Medical Hypotheses 76 (2011) 887-892.
Only 13% of candidates receive total knee replacements
11
• African Americans are 39% less likely than Caucasians to receive total knee replacements.29
Wide racial disparities exist in the delivery of total joint replacement surgery
“Racial Disparities in Total Knee Replacement Among Medicare Enrollees United States,” 2000-2006, MMWR Weekly, Centers for Disease Control, February 20, 2009.
TKR Rate 2000 TKR Rate 2006TKR
rate
per
100
0 po
pula
tion
TKR rate per 1000 population, 2000 and 2006
African Americans
3.6 5.6
5.7 9.2
Despite similar disease prevalence, African Americans are 39% less likely to receive total knee replacement surgery
Caucasian Americans
• Patients who do not have timely treatment have been shown to deteriorate in function.30-32
• This is consistent with earlier evidence that “patients operated upon earlier in the course of functional decline had better outcomes.”33
• Patients eligible for joint replacement who undergo the procedure have better clinical outcomes at 12 months than comparable patients who do not.34
• Not having a joint replacement has a negative and significant impact on pain and may harm patients who self-ration, or are otherwise restricted in access to timely care.35-39
• Delaying surgery in patients with severe knee OA is not cost-effective.40
• In fact, delaying total knee replacement in patients who have reached end-stage knee OA that severely limits their functions “is never efficient because it leads to a lesser value per dollar spent.”41
Timely treatment = better outcomes
12
• The vast majority of primary care physicians have been shown to inadequately understand the benefits of total joint replacement, and do not appropriately discuss total joint replacement as an option with many indicated patients.42, 43
• Only 17% of primary care physicians correctly identified total joint replacement success rates.44
• Only 26% of primary care physicians discussed total joint replacement with elderly candidates.45
Primary care physicians: do they make timely referrals?
Primary care physicians and total joint replacement
17% 26%Ang, et al.
JAGS, January, 2007Schonberg, et al.
JAGS, January, 2009
Correctly identified TJR success rate
Discussed TJR with candidates for surgery
13
• Impending surgeon shortages may result in further reductions in access to needed care.46, 47
• From 2005-2020, the supply of all orthopaedic surgeons is expected to increase 2%, while the demand for orthopaedic surgeons’ services is expected to increase 23%.48
• However, the number of orthopaedic surgeons who perform total joint replacement surgery is expected to decline 34% by 2016 as compared to 2008.49
Joint replacement surgeons expected to decline in number by 2016
18%20%
3%21%
2%23%
Primary Care
Surgical Specialists
Orthopedic Surgeons
PATIENT DEMAND *
PHYSICIAN SUPPLY *
PATIENT DEMAND *
PHYSICIAN SUPPLY *
PATIENT DEMAND *
PHYSICIAN SUPPLY *
PROJECTED % CHANGE 2005-2020 *
Growth in physician supply vs. patient demand, 2005-2020 HRSA, 2008
14
Risks associated with total joint replacement
Surgeons should explain all risks to their patients. For more information, please consult the informa-tion at the following websites:
http://orthoinfo.aaos.org/topic.cfm?topic=A00375http://www.niams.nih.gov/Health_Info/Joint_Replacement/
Potential adverse outcomes associated with joint replacement [any of which may necessitate re-op-eration to revise or replace the implant(s)] include but are not limited to breakage of the device itself, loosening, intra-operative or post-operative fracture of the bone or instrument(s), infection, wear, and disassociation or migration of the implant. Risks may be affected by patient factors such as age, weight, activity level, rehabilitation compliance and the presence of co-morbidities, as well as by the surgical procedure.50 Complications associated with the surgical procedure can include in-correct ligament balancing, poor cement technique and mal-rotation of implant parts.51 Any of these can require revision surgery. Early, severe adverse events are reported in under 6% of patients and most often become manifest within four days following the implant procedure.52, 53 These cannot be reliably predicted in nearly 60% of patients by preoperative risk evaluation.54
Joint replacement surgeons: 34% decline projected 2008-2016
75855038
Joint Surgeons2008
Joint Surgeons2016 projected
Fehring, et al., J. Arthroplasy, 2010
15
1. “Osteoarthritis Risk Factors,” Mayo Clinic, available at http://www.mayoclinic.com/health/osteoarthritis/DS000192. Lawrence RC, Felson DT, Helmick CG, et al., “Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions
in the United States, Part II,” Arthritis &Rheumatism 2008; 58(1): 26-35. http://onlinelibrary.wiley.com/doi/10.1002/art.23176/full
3. Murphy L, Helmick CG, “The Impact of Osteoarthritis in the United States: A Population-Health Perspective,“ American Journal of Nursing, March 2012, Vol. 112, No. 3. http://www.usbjd.org/projects/files/02.Murphy-Helmick_AJN-v112-n3-S1%20(Yes).pdf
4. White DK, et al., “Reasons for Functional Decline Despite Reductions in Knee Pain: The Multicenter Osteoarthritis Study,” Physical Therapy, 2011; 91:1849-1856. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3229048/
5. “Osteoarthritis Risk Factors,” Mayo Clinic, available at http://www.mayoclinic.com/health/osteoarthritis/DS000196. London NJ, et al., “Clinical and Economic Consequences of the Treatment Gap in Knee Osteoarthritis Management,”
Medical Hypotheses 76 (2011) 887-892.7. Burden of Musculoskeletal Disease, U.S. Bone and Joint Initiative, 2011.http://www.boneandjointburden.org/8. Ibid.9. DiBonaventura M, et al., “Impact of Self-Rated Osteoarthritis Severity in an Employed Population: Cross-sectional Analysis
of Data from the National Health and Wellness Survey,” Health and Quality of Life Outcomes 2012, 10:30. http://www.biomedcentral.com/content/pdf/1477-7525-10-30.pdf
10. Nuesch E, et al., “All Cause and Disease Specific Mortality in Patients with Knee or Hip Osteoarthritis: Population Based Cohort Study,” British Medical Journal 2011; 42:d1165doi:10.1136/bmj.d1165 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3050438/pdf/bmj.d1165.pdf
11. Dunlop DD, et al., “Objective Physical Activity Measurement in the Osteoarthritis Initiative: Are Guidelines Being Met?” Arthritis & Rheumatism, Vol. 63, No. 11, November 2011, pp. 3372-3382. http://onlinelibrary.wiley.com/doi/10.1002/art.30562/pdf
12. CDC. Arthritis. http://www.cdc.gov/arthritis/index.htm. Accessed online August 7, 2013.13. Nunley RM, et al., “Do Patients Return to Work After Hip Arthroplasty Surgery,” Journal ofArthroplasty, Vol. 26 No. 6 Sup-
pl. 1, 2011. 14. Lombardi AV, et al., “Do Patients Return to Work after Total Knee Arthroplasty,” Clinical Orthopaedics and Related Re-
search, June 13, 2013. http://www.ncbi.nlm.nih.gov/pubmed/2376117515. Cushner F, et al., “Complications and Functional Outcomes After Total Hip Arthroplasty and Total Knee Arthroplasty:
Results From the Global Orthopaedic Registry (GLORY),” Am. J. Orthop 2010 Sep; 39(9 Suppl): 22-8. http://www.amjortho-pedics.com/PDF/039090022s.pdf
16. Dall TM, et al., “Modeling the Indirect Economic Implications of Musculoskeletal Disorders and Treatments,” Cost Effec-tiveness and Resource Allocation, 2013, 11:5, available at http://www.resource-allocation.com/content/pdf/1478-7547-11-5.pdf
17. Lovald ST, et al., “Mortality, Cost, and Health Outcomes of Total Knee Arthroplasty in Medicare Patients,” Journal of Arthroplasty, November 12, 2012.
18. “Mortality, Cost, and Downstream Disease of Total Hip Arthroplasty Patients in the Medicare Population,” Journal of Arthroplasty, May 2013
19. National joint replacement registries for: England and Wales, 2012; Australia, 2012; Sweden Hip Replacement, 2011; Sweden Knee Replacement, 2010; http://www.njrcentre.org.uk/NjrCentre/Portals/0/Documents/England/Reports/9th_annual_report/NJR%209th%20Annual%20Report%202012.pdf; https://aoanjrr.dmac.adelaide.edu.au/documents/10180/60142/Annual%20Report%202012?version=1.3&t=1361226543157; http://www.shpr.se/Files/Årsrap-port%202011%20(eng)%20webb.pdf; http://www.knee.nko.se/english/online/uploadedFiles/117_SKAR_2012_Engl_1.0.pdf
20. Paxton EW, et al., “A Prospective Study of 80,000 Total Joint and 5,000 Anterior Cruciate Ligament Reconstruction Proce-dures in a Community-Based Registry in the United States,” Journal of Bone &Joint Surgery 2010; 92:117-132.
21. Ruiz D, et al., “The Direct and Indirect Costs to Society of Treatment for End-Stage Knee Osteoarthritis,” Journal of Bone and Joint Surgery, 2013; 95: 1473-80.
22. London NJ, Miller LE, Block JE. “Clinical and Economic Consequences of the Treatment Gap in Knee Osteoarthritis Man-agement.” Medical Hypotheses 2011;76:887-892.
23. George LK, et al., “The Effects of Total Hip Arthroplasty on Physical Functioning in the Older Population,” Journal of the American Geriatric Society, 56: 1057-1062, 2008.
24. Hawker GA, Wright JG, Coyte PC et al. “Differences Between Men and Women in the Rate of Use of Hip and Knee Arthro-plasty.” New England Journal of Medicine 2000;342:1016-1022.
25. Hawker GA, Wright JG, Coyte PC, et al. “Determining the Need for Hip and Knee Arthroplasty: The Role of Clinical Severity and Patients’ Preferences.” Medical Care 2001;39:206-216.
26. Hawker GA, Wright JG, Badley EM, Coyte PC. “Perceptions of, and Willingness to Consider, Total Joint Arthroplasty in a Population-based Cohort of Individuals with Disabling Hip and Knee Arthritis.” Arthritis &Rheumatism 2004;51:635-641.
27. Hawker GA, Guan J, Croxford R, et al. “A Prospective Population-based Study of the Predictors of Undergoing Total Joint Arthroplasty.” Arthritis &Rheumatism 2006;54:3212-3220.
28. Hawker GA, Wright JG, Coyte PC et al. “Differences Between Men and Women in the Rate of Use of Hip and Knee Arthro-plasty.” New England Journal of Medicine 2000;342:1016-1022.
29. “Racial Disparities in Total Knee Replacement Among Medicare Enrollees – United States, 2000-2006,” Morbidity & Mor-tality Weekly Reports, Centers for Disease Control, February 20, 2009. http://www.cdc.gov/mmwr/preview/mmwrhtml/
References
16
mm5806a1.htm30. George LK, et al., “The Effects of Total Hip Arthroplasty on Physical Functioning in the Older Population,” Journal of the
American Geriatric Society, 56: 1057-1062, 2008.31. George LK, et al., “The Effects of Total Knee Arthroplasty on Physical Functioning in the Older Population,” Arthritis &
Rheumatism, Vol. 58, No. 10, October, 2008, pp. 3166-3171 32. Desmeules F, et al.: “The Burden of Wait for Knee Replacement Surgery: Effects on Pain, Function and Health-Related
Quality of Life at the Time of Surgery,” Rheumatology 2010: 49:945-954. 33. Fortin PR, Penrod JR, Clarke AE et al. “Timing of Total Joint Replacement Affects Clinical Outcomes Among Patients with
Osteoarthritis of the Hip or Knee.”Arthritis &Rheumatism 2002;46:3327-3330.34. Hamel MB, Toth M, Legedza A, Rosen MP. “Joint Replacement Surgery in Elderly Patients with Severe Osteoarthritis
of the Hip or Knee: Decision Making, Postoperative Recovery, and Clinical Outcomes. Archives of Internal Medicine, 2008;168:1430-1440.
35. George LK, et al., “The Effects of Total Hip Arthroplasty on Physical Functioning in the Older Population,” Journal of the American Geriatric Society, 56: 1057-1062, 2008.
36. George LK, et al., “The Effects of Total Knee Arthroplasty on Physical Functioning in the Older Population,” Arthritis & Rheumatism, Vol. 58, No. 10, October, 2008, pp. 3166-3171
37. Desmeules F, et al.: “The Burden of Wait for Knee Replacement Surgery: Effects on Pain, Function and Health-Related Quality of Life at the Time of Surgery,” Rheumatology 2010: 49:945-954.
38. Hajat S., et al., “Does Waiting for Total Hip Replacement Matter? Prospective Cohort Study,” Journal of Health Services Research and Policy, 2002 Jan; 7(1): 19-25.
39. Rossi MD, et al., “Delaying Knee Replacement and Implications for Early Postoperative Outcomes: A Pilot Study,” Orthope-dics, December 2009 – Volume 32, Issue 12. http://www.healio.com/orthopedics/journals/ORTHO/%7B7FBF9D60-4B37-4AF8-8A53-48B600D0EE3C%7D/Delaying-Knee-Replacement-and-Implications-on-Early-Postoperative-Outcomes-A-Pi-lot-Study
40. Losina E, et al., “Cost-Effectiveness of Total Knee Arthroplasty in the United States: Patient Risk and Hospital Volume,” Archives of Internal Medicine, Vol. 169 (No. 12), June 22, 2009.
41. Ibid.42. Ang DC, et al., “An Exploratory Study of Primary Care Physician Decision Making Regarding Total Joint Arthroplasty,”
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43. Schonberg MA, et al., “Perceptions of Physician Recommendations for Joint Replacement Surgery by Older Patients with Severe Hip or Knee Osteoarthritis,” Journal of the American Geriatric Society. 2009 January; 57(1): 82-88. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2631618/
44. Ang DC, et al., “An Exploratory Study of Primary Care Physician Decision Making Regarding Total Joint Arthroplasty,” Journal of General Internal Medicine, January 9, 2007, http://www.torna.do/s/An-exploratory-study-of-primary-care-phy-sician-decision-making-regarding-total-joint-arthroplasty/
45. Schonberg MA, et al., “Perceptions of Physician Recommendations for Joint Replacement Surgery by Older Patients with Severe Hip or Knee Osteoarthritis,” Journal of the American Geriatric Society. 2009 January; 57(1): 82-88, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2631618/
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47. Fehring TK, et al., “Joint Replacement Access in 2016: A Supply Side Crisis,” Journal of Arthroplasty, Vol. 25 No. 8, 2010. http://www6.aaos.org/news/PDFopen/PDFopen.cfm?page_url=http://www.aaos.org/news/acadnews/2013/AAOS16_3_22.asp
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49. Fehring TK, et al., “Joint Replacement Access in 2016: A Supply Side Crisis,” Journal of Arthroplasty, Vol. 25 No. 8, 2010. http://www6.aaos.org/news/PDFopen/PDFopen.cfm?page_url=http://www.aaos.org/news/acadnews/2013/AAOS16_3_22.asp
50. Goldberg VM, Buckwalter J, Halpin M et al. “Recommendations of the OARSI FDA Osteoarthritis Devices Working Group.” Osteoarthritis Cartilage, 2011;19:509-514.
51. Ibid.52. Ng VY, Lustenberger D, Hoang K, et al. “Preoperative Risk Stratification and Risk Reduction for Total Joint Reconstruction:
AAOS Exhibit Selection.” Journal of Bone &Joint Surgery 2013;95:e191-15.53. Parvizi J, Mui A, Purtill JJ, Sharkey PF, Hozack WJ, Rothman RH. “Total Joint Arthroplasty: When Do Fatal or Near-fatal Com-
plications Occur?” Journal of Bone &Joint Surgery 2007;89:27-32.54. Ibid.
17
