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Jess H. Lonner, MDPhiladelphia, PA
Disclosure
Royalties
Zimmer, Blue Belt Technologies
Consultant
Zimmer, Blue Belt Technologies
Speaker’s bureau
Zimmer, Blue Belt Technologies
Publishers: Saunders, Lippincott Williams Wilkins
Shareholder: Blue Belt Technologies, CD Diagnostics
“Conventional” Approach to
Knee Arthritis
90-94% “success” at 10-15 yrs
Total Knee
Replacement
Patients Decline Total Knee
Replacement Surgery
Few patients opt for TKA
12.7% of women
8% of men
Duke University Knee StudyAssessing the Impact of Medical Technology Innovations on Human Capital
January 31, 2006
Reasons for Declining Surgery
Concern: pain or worsened mobility
Duration of recovery
Financial
Lost work
“Friends of friends” with poor outcomes
Poorly informed re benefits/alternatives
Dissatisfaction after Total
Knee Replacement
19%-25% dissatisfaction
Recovery lengthy
Activity limitations
Expectations unmet
6-17% residual anterior knee pain
Knees don’t feel normal
Noble et al, Clin Orthop 2006
Bourne et al, Clin Orthop 2010
Not all patients need total knee replacements
Issue #1
Only 6% of knees have arthritis in
ALL 3 compartments
Patterns of OA in Symptomatic Knees
(Ledingham et al 1993)
Prevalence of Localized Knee
Arthritis
13-47% of the patient population
Willis-Owes 2009
Schindler 2010
Ackroyd 2010
Arno/Walker PS 2011
Continuum of Interventions
Partial Knee
Replacements
Total
Knee
Choice of Knee Replacement
Depends on:
Pattern of arthritis
Deformity
Contractures
Stability
Body habitus
Knee Replacement Options
Partial Knee
Total Knee
30%
70%
Advantages of Partial Knee
Replacement
Accelerated recovery Less pain Less blood loss Less postop morbidity Shorter hospitalization More conservative Lower costs Feels more normal Greater satisfaction
0
20
40
60
80
100
120
0 3 mos 6 mos 9 mos 12 mos
Pain
Partial
Knee
Total
Knee
“Recovery” after Partial Knee Replacement
Time to “Recovery”:
Partial vs. Total Knee Replacement
Extent of “Recovery”:
Partial vs. Total Knee Replacement
0
0.5
1
1.5
2
2.5
3
Abilitytoperformac vi esofdailyliving
"Feltnormal"
Partial Knee vs.
Total Knee Replacement
TKA
Par al
Nunley et al 2014
Patient Satisfaction
Total vs. Partial Knee Repl.
Total
75-81%
Noble (2006), Bourne (2011)
Partial
94%
Bhattacharya (2011)
Safety: Partial vs Total
30-Day Complications: Partial vs.
Total Knee Replacement> 20,000 pts (Medicare/Marketscan
Databases)
Lonner et al 2014
Durability of Partial Knee
Replacements
94% survivorship at 10-15 yrs in optimal
circumstances…
Durability: Partials vs. Totals(US Databases)
< Age 65
> Age 65
Ong, Lonner etal AAHKS 2014
Partials Totals
Partials Totals
Optimizing the outcomes and durability of partial knee replacement is paramount
Issue #2
What Impacts the Results of
Partial Knee Replacements?
Pattern of arthritis
Patient selection
Component design
Polyethylene quality
What Impacts the Results of
Partial Knee Replacement?
Accuracy of implantation
BadGood
Partial Knees with Traditional Instrumentation
Difficult to consistently align components
Malalignment leads to failures
Evolution
Bulky instrumentation
Computer Navigation
Robotics
Rationale of Robotics for Partial
Knees
Simplify the procedure
Reduce the amount of instrumentation
Eliminate surgical steps
Enhance accuracy
Bone preparation/component alignment
Soft tissue balance
Improve clinical results
Lonner JH. American Journal of Orthopedics 2009
Experience with Orthopaedic
Robots
Broader adoption of semi-autonomous systems
Expanded indications
Explosion
Newer companies/technologies
Market Penetration of
Robotics in Partial Knees
15% of partial knee’s in US (2013)
www.OrthopedicNetworkNews.com. 2013
Partial knees
~29% in five years
~37% in 10 years
Total knees
~10% in two years
~18% in five years
~23% in ten years
Robotic Landscape:
Projected Penetration
Medical Device and Diagnostic Industry, March 5, 2015http://www.mddionline.com
Semi-autonomous
Robotics for Partial Knees
Mako (Mako Stryker, Ft. Lauderdale, FL)
Initial FDA approval 2005; revised 2008
Image-based (CT scan)
Navio Surgical System (Blue Belt Technologies,
Plymouth, MN)
Initial FDA approval 2012
Image-free
Story of Robotics in
Orthopaedics
Study in patterns that define technological
progress and innovation, in general
Declining capital and maintenance costs
Smaller space requirements
Broadening access
Increased utilization
Downsides of 1st Generation
Robotic System
Capital expense
Preop CT scan
Additional expense
Denials common; high copays; bundled payments
Hospitals “eat cost”
Time/Inconvenience
Radiation exposure
2nd Generation Robotic System
Image-free (No CT scan)
Handheld robotic instrument
Intraop registration/mapping/planning
Intraop gap balancing
Burr Speed/Exposure control
2nd Generation Robotic System
Cost-favorable
Open implant platform
Blue Belt Technologies, DePuy Synthes,
DJO Surgical, Smith & Nephew, StelKast
34% currently in ASC’s
Navio Technique:
Surface Mapping
Selection of Implant Size/Position
and Virtual Gap Balance
Technique: Bone Preparation
Prepared Surface
Alignment:
Robotic Techniques vs. Manual
RMS Error Robotic Manual
Flex/Ext (°) 1.6 4.1
Varus/Valgus (°) 2.3 6.0
Int/Ext (°) 1.7 6.3
Prox/Dist (mm) 1.3 2.8
Ant/Post (mm) 1.3 2.4
Med/Lat (mm) 0.9 1.6
Lonner et al CORR 2010
Dunbar et al J Arthrop 2012
Lonner et al CORR 2014
2.6x less variability than manual techniques (p<0.05)
Partial Knee Replacement Durability with Robotic Assistance
860 cases
Mean f/u 4.6 yrs (range, 6 mos-7 yrs)
Failure rate: 0.5%
(Lonner et al 2015
The value paradigm in knee replacement surgery
Issue #3
Problem Defined
Healthcare costs exceed 17% of GDP
Expected to exceed 20% by 2020
2009: $2.5 trillion spent on US healthcare
Projected to be >$4.6 trillion by 2020
2009: Per capita healthcare spending: $8000
Estimated to be $13,700 by 2020 (70% increase)
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-
Reports/NationalHealthExpend-Data/downloads/proj2010.pdf
Cost of managing musculoskeletal disease:
$849 billion (7.7% of GDP)
Volume growth 2005 to 2030:
Total knees: 450,000 3.48 million (673%)
Total hips: 208,600 572,000 (174%)
Growing “Burden” of Total
Knee and Hip Replacement
Kurtz et al J Bone Joint Surg 2007; American Academy of Orthopaedic Surgeons
Value Impact
Payers are encouraging value-driven choices
Payers are selecting surgeons/hospitals that they
consider high value, low cost providers based on their
outcomes
Payment incentives focus on quality over quantity
Penalties for readmissions
We need to optimize care (value)
Patient satisfaction?
Improved functional outcomes?
Implant durability?
Rapid recovery?
Quick return to work?
Patient optimization?
Minimization of complications?
Short-term cost avoidance?
Long-term cost-avoidance?
What is “Value” in Joint
Replacement?
“Value” in the New
Healthcare Paradigm
Value = Quality/Cost
(Health outcomes achieved per dollar spent)
Michael Porter, NEJM 2010
Minimize costs for EOC
Optimize patients medically
Minimize complications
Periop protocols
Educate patients
Re-evaluate cost of care at hospitals
Minimize use of inpt facilities postop
Transition select cases to ASC’s
Shift from total knees to partial knee replacements
How Do We Get Better Value?
Partial knee replacement must be provided as an outpatient procedure
Medicare “Mandate”
CMS policy 1589-P 2013
Is outpatient partial knee replacement safe?
Does robotic technology support the new value paradigm in healthcare?
Are robotics safe and cost effective in an ASC?
Issue #4
Feasibility Study: Outpatient
Partial Knee Replacement
200 consecutive “selected” cases
50% in an ASC
Patient age: mean 58 (range, 35-82)
100% discharged home
One (0.5%) return to ED on POD #1 for IV fluid
No readmissions
Lonner et al 2014
Costs of Care (Partial Knees)
Uhr A, Davis D, Lonner J. 2015
Cohort Mean Min Max
Hospital (Inpatient)N=50
$16,495 $12,784 $28,644
Hospital (Outpatient)N=50
$13,295 $7,249 $24,758
ASCN=50
$9,969 $3,406 $15,321
Economics of Robotic
Technologies
1st Gen Pricing 2nd Gen Pricing
-List price ~$1.0MM -List price $445k with 1 year of warranty
-$100k annual warranty list price
-$45k annual warranty list price
53
1st Gen Case Considerations 2nd Gen Case Considerations
-Per case disposables: $1,200 -Per case disposables: $600
-Confined to Mako’s RESTORIS, Stryker?
-Multiple implant options; leverage RFP’s
-CT scan required; insurance denials -No CT & pre-op planning required
-40 minute setup time -15 minute setup, no complex calibration
-Difficult to move from install location
-Portability; b/t rooms and facilities
Economics of Robotic
Technologies
Assumptions:
Avg. Medicare payment per case: $12,500
Lien Item 1st Generation 2nd Generation
System List Price $1,200,000 $450,000
Svc Costs (List Price)
$100,000 $45,000
CT scan $400-$800 $0
Implant/Disposable Costs
negotiated negotiated
Break even on ROI 240 cases 60 cases
ROI Pro Forma Analysis
55
Conclusion
Partial knee replacement
Conservative alternative to total knees
Rapid recovery
Greater return to work and sport
Normal kinematics/feel
Less morbidity/risk
Improved satisfaction
Conclusion
Robotically-assisted surgery
Improves precision of bone preparation
Optimizes ligament balance
Enhances position of components
Optimizes outcomes and durability
Conclusion
Partial knees and newer generation robotic systems:
Cost favorable for ASC
Support the value-paradigm