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Robotic Technology…A Vision
For The Future
David Jacofsky, MD
Chairman
The CORE Institute
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The data included in this presentation was collected and is owned by the surgeon author of this presentation. The opinions expressed by David Jacofsky, MD during this presentation are those of David Jacofsky, MDand not necessarily those of Stryker.
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"Where a calculator on the ENIAC is equipped with 18,000 vacuum tubes and weighs 30 tons, computers in the future may have only 1,000
vacuum tubes and weigh only 1.5 tons." Popular Mechanics, 1949
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"The concept is interesting and well-formed, but in order to earn better than a 'C', the idea
must be feasible.”A Yale University management professor in response to Fred Smith's paper proposing reliable overnight
delivery service.
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"I think there is a world market for maybe five computers.”
Thomas J. Watson, chairman of IBM, on seeing the first mainframe computer in 1943.
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"There's no chance that the iPhone is going to get any significant market share.”Steve Ballmer, USA Today, April 30, 2007
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“Clinical” Challenge
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Cardiac & Orthopedic Markets
9
Source: Richard Iorio, MD et. al., Orthopaedic Surgeon Workforce and Volume Assessment for Total Hip and Knee Replacement in the United States: Preparing for an Epidemic. The Journal of Bone and Joint Surgery (American).
Source: Jersey Chen, et. al., Recent Declines in Hospitalizations for Acute Myocardial Infarction for Medicare Fee-for-Service Beneficiaries: Progress and Continuing Challenges. March 23, 2010. Circulation.
+600% Growth in Knee Replacement
+200% Growth in Hip Replacement
In T
ho
usa
nd
s
23% decreaseIn
Th
ou
san
ds
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Service Line Growth Forecast
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Business Challenge
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Physician/Hospital Challenges
In my opinion they need to:
• Increase volumes to maintain income.
• Increase ability to have midlevel providers function at the ceiling of their licensure.
• Increase episode of care margins due to bundled payments, ACOs, and co-management programs.
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Examples of where robots are better than humans etc.
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Robotic Technology…
• Deliver and move merchandise.
• Make burgers.
• Fly planes.
• Drive farm equipment.
• Replace cashiers.
• Make iProducts.
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What is the point of the Mako
System?
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Potential Benefits of Orthopedic Robotic-Arm
Assisted Surgery:
Potential Benefits Category Sources
Reduction of blood loss Clinical & Cost Savings
1. Robotic Arm Assisted THA Improved Accuracy, Reproducibility, and Outcomes Compared to
Conventional Technique. Il lgen R. 43rd Annual Course: Advances in Arthroplasty, October 22-25,
2013, Boston, MA.
Reduced length of stay Cost Savings & Efficiency Strathclyde RCT PDF
Increased Accuracy Clinical & EfficiencyBragdon C, Elson L, Padgett D, Marchand R, Dounchis J. A Multicenter Evaluation of
Acetabular Cup Positioning
Increased volume ( Halo effect ) Profitability 1)Brandt Case Study 2) Padden Case Study
Payer mix shift Profitability Hunter T, Slover J, Hutzler L, Bosco J. Relative Contribution of Different Cost Centers to the Entire
Episode of Care for TKA.
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0
50
100
150
200
250
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
2007 2008 2009 2010 2011 2012 2013 2014
Total HIP
Partial Knee
OR Systems Installed
Pro
ced
ure
s P
erfo
rmed
Syst
ems
Inst
alle
d
• 250+ Mako systems in U.S.
• Over 60,000 procedures completed (uni+hip)
• 44 Published Peer-Reviewed Clinical Articles
• 2000+ Abstracts
• 70 Ongoing Clinical Trials
• Acquired by Stryker Dec. 2013 ~ $1.65B
Mako System Growth
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• Can a surgeon with a Mako System doing a TJA ever…
– Cut the MCL?
– Cut the popliteal artery?
– Malposition an acetabular component?
– Create a LLD?
For Me: Questions to Consider Over Time…
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• High volume TKA focused factory.
• Think episode, not procedure.
Just in time inventory
Ortho IQ concept (drapes, gloves, hoods, implant, TXA doses, exparil dose, disposables, etc.)
SecureTracks
Home PT and monitoring for ROM, distance walked, pain scores, etc.
• Consumer demand for surgery at this center driving physician change.
• Financial incentive for physician to use this model due to efficiency and outcomes.
• Overall cost reduction strategy in line with future of payor reform.
• Primary disposition outpatient or 23 hour stay.
My Vision of The Possible Future
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My Example Case
Incision
Complete exposure and registration
Robotic-arm assisted cutting completed
Implants and closure
40 minute turnover time
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OR 1 OR 3OR 2 OR 4
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Managing Your Innovation Portfolio, Harvard Business Review, May 2012, Nagji and Tuff
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Potential Financial Benefits
• Physician and Facility
– Increased volumes and throughput
• Increased market share.
• Increased efficiency and throughput.
– Consumer demand for robotic technology driving surgeon conversion
• Savings passed through in capitation, ACOs, bundled payments.
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Other Potential Benefits
• Device Manufacturers
– No need for instruments
• 3-5M annually in lost and stolen.
• 10M annually in maintenance and management.
• If new implant design is launched then savings of over 325M in instrument costs…drives new implant design.
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“... it ought to be remembered that there is nothing more difficult to take in hand,
more perilous to conduct, or more uncertain in its success,
than to take the lead in the introduction of a new order of things.”
Nicolo Machiavelli, The Prince1515
Questions?
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The data included in this presentation was collected and is owned by the surgeon author of this presentation. The opinions expressed by David Jacofsky, MD during this presentation are those of David Jacofsky, MD
and not necessarily those of Stryker.
2/29/2016
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Hip replacement using Mako
Robotic-Arm Assisted Surgery
Joseph Nessler MDSaint Cloud Orthopedics
Sartell MN, USA
Saint Cloud Surgical Center
Saint Cloud MN, USA
Consultant , Stryker
My experience
Disclaimer: The opinions expressed by Joseph Nessler, MD during this presentation are those of Joseph Nessler, MD and not necessarily those of Stryker.
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Complications in total hip arthroplasty
• Short term• Dislocation is the leading short term complication for total hip
replacements1 -- national average is around 2.5%1
• Leg length discrepancy
• Long term• Implant loosening
• Accelerated wear
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Joe’s top reasons for switching to Mako
1. I want better outcomes for my patients
2. Admit everyone has outliers
3. Not all outliers fail, but in most circumstances outliers fail more often
4. Forced to plan and THINK about the case before you cut!
5. Designed to help avoid complications with tools (eccentric reaming, incorrect COR, reaming through the pelvis)
6. Allows me to the leg lengths right!
7. Admit you’re not perfect
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About 50% of acetabular cups are malpositioned according a recent paper published from Massachusetts General Hospital2
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Malpositioned acetabular cups
Implant alignment/balancing options - my journey
Precision
surgical assistance
1991-2003
Manual alignment guides
2004-2015
Navigation systems2015-present
Mako Total Hip and Partial Knee
Conventional
techniques
Advanced
alignment tools
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Predictable
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Pre-operative planning
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Pre-operative planning
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3-D view X-ray view
Intraoperative registration
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Intraoperative registration
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Guided single stage reaming
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Guided single stage reaming
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Robotic-arm assistance
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• Measures: inclination, version and depth to seating
• Auditory, visual and tactile feedback
Fluctuation of Cup Orientation During Press-Fit Insertion: A Possible Cause of MalpositioningTakashi Nishii, MD, Takashi Sakai, MD, Masaki Takao,
MD, Nobuhiko Sugano, MDReceived: December 30, 2014; Accepted: April 27, 2015;
Published Online: May 05, 2015, JOA
Robotic-arm assisted cup placement
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Pre-op planning compared to post-op
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Predictable
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• Within first ten cases, surgical time minimal difference to pre-robotic times (experienced with surgical navigation for over a decade)
• Most recent cases, three minutes faster than prior to using Mako
• Typical skin incision time to all final implants in range 30-50 minutes, avg. ~ 40 minutes
• Outpatient center experience:
– Six-months of use
– Five surgeons using Mako
– Six trained
– Second Mako System purchased and in use
My experience to date
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• Reduced risk of leg length discrepancy
• Decreased risk of dislocation
• Potential for enhanced soft tissue tension of the hip
• Potential for enhanced post-operative range of motion
• Potential for enhanced implant survivorship
• Potential for rapid pain relief and return to daily activities
• When combined with muscle-sparing approach and post-operative pain protocols
My reasons to believe in the technology
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References
1. Phillips CB, Barrett J, Losina E, et al. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective Total Hip Replacement. J Bone Joint Surg Am. 2003;85:2026.
2. Callanan MC, et al. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. CORR 2011;469(2):319
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A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.
The information presented is intended to demonstrate the breadth of Stryker's product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any of Stryker's products. The products depicted are CE marked according to the Medical Device Directive 93/42/EEC. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your sales representative if you have questions about the availability of products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Mako, Stryker. All other trademarks are trademarks of their respective owners or holders.
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2/25/2016
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Clinical Results with Mako
Robotic-Arm Assisted Surgery
for UKA
Dr. Martin Roche
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The data included in this presentation was collected and is owned by the surgeon author of this presentation. The opinions expressed by Martin Roche, MD during this presentation are those of Martin Roche, MD and not necessarily those of Stryker.
Why Do I Use Mako Robotic-Arm Assisted Surgery for UKA’s ?
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Clinical Research Presence
• >50 published peer-reviewed manuscripts
• >300 abstracts accepted at peer-reviewed
scientific meetings
– >150 podiums (including presentations at the
Knee and Hip Societies)
– >150 posters
– Worldwide scientific presence: USA, Israel, Japan,
Korea, UK, Netherlands, Belgium, Germany, Italy,
Turkey, Thailand, China, Czech Republic, France,
Canada, Australia
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My Top Reasons to Use Robotic Technology
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Mako Partial Knee More of a “Forgotten Joint” than TKA
Background:
The Forgotten Joint Score (FJS) is a Patient Reported Outcome (PRO) that has the ability to distinguish between good and excellent outcomes and is not limited by ceiling effects.
Methodology:• Two patient groups:
– 64 robotic-arm assisted medial UKR
– 64 manual TKA
• Patients were assessed at 12 months for:
– Forgotten Joint Score
– EQ5D
– WOMAC
• No significant differences in age, gender distribution, and BMI
Key Results:• The mean FJS in the medial UKA group was significantly higher than the TKA group: 73.9 ± 22.8 vs. 59.3 ±
29.5 (p<0.05)
• Traditional PROMs did not show any significant differences between the groups
Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty: Are We Able to Create the Forgotten Joint. Pearle AP, et al,. 14th Annual CAOS Meeting, June18-21, 2014, Milan, IT.
73.9
59.3
0
20
40
60
80
UKA TKA
Forgotten Joint Score
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Research Question:
• Is UKA cost effective compared to TKA? And if so, does it depend on the patient’s age?
Methodology:
• Markov model with data from Swedish national joint registry, published literature, and HCUP from HSS registry. Data was input into the model for UKA and TKA.
• Assumption: UKA and TKA experience same post-operative increase in quality of life.
Key Results:
• In patient age groups 65, 75 and 85, UKA was dominant! (UKA less expensive AND more effective). This is primarily due to the high rehabilitation costs of TKA, even with higher UKA revision rates.
• In patient age groups 45 and 55, TKA is slightly more expensive, but also slightly more effective, however UKA would be dominant if technological advances could result in:
– slightly improved quality of life (model assumes same post-operative QOL for TKA and UKA, which we have found to be higher for UKA)
– reduction in UKA revision rate (model uses registry data, which we have shown to be 2-4 times higher than MAKO UKA revision rates)
UKA is more cost effective than TKA in patients over 65
Effect of Age on Cost effectiveness of UKA vs TKA in the US. Pearle A, Ghomrami H. J Bone Joint Surg Am. 2015; 97:396-402
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Methodology:• 18 patients (26 knees) received TKA (n=18) or Robotic Arm
Assisted UKA (n=9).• Each patient received a uniform physical therapy (PT) regimen.
– PT was determined to be successfully completed when each patient reached the following functional goals:
– ROM 5-115 degrees
– Recovery of flexion/extension strength to 4/5 pre-operative strength
– 250 feet of gait with minimal limp and no assistive device
– Ability to ascend/descend a flight of stairs with step over gait and good control
Key Result:• Early results show less physical therapy is required for UKA
patients than TKA patients to reach the same functional goals• No statistical differences in PROMs at pre-op, 2 week, 6 week at
same follow-up• PT accounts for a significant portion of the episode of care and
thus quicker recovery may result in a decreased economic burden
UKA Patients Return to Function Earlier than TKA Patients. Borus T; Roberts D; Fairchild P; Christopher J; Conditt M; Matthews J. 27th Annual Congress of ISTA, September 15-27, 2014; Kyoto, Japan.
Robotic- Arm Assisted UKA Patients Return to Function More
Quickly than TKA Patients
TKA UKA p-value
Extension (5)5 ±4.1
2.4 ±1.4
p=0.0411
Flexion (115)5 ±1.7
3.8 ±2.1
p=0.0004
Ext/Flex Strength
9.8 ±3.0
6.4 ±1.8
p=0.0319
Gait w/o AD6.8 ±2.8
3.8 ±1.6
p=0.0022
Stair Ascend/Descend
10.5 ± 4.2
7.1 ±1.6
p=0.0277
All Criteria10.2 ± 3.0
8.6 ±1.9
p=0.183
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Robotic Technology
Integrating New Technology in MY OR
Partnership Investment from Hospital
Marketing of Robotic Technology
“Halo Effect” Increased overall Knee Surgeries
Evolution of Outpatient Surgery
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My Manual Approach – Inconsistent Outcomes
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CT Scan Based Technology
Pre-op Planning is Patient Specific
(screen shot –femur/tibia)
(screen shot –implant(s)
in femur/tibia)
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Helps to Define Alignment Pre-Cut and Adjust Implants to
Achieve Surgical Goals
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Helps to Define Gaps and Kinematics
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Methodology:• 38 Mako PKA cases from 1 surgeon were analyzed for frequency
and magnitude of intra-operative adjustments • All patient plans analyzed for intra-operative planning leading up
to bony cuts
Key Results:• Implant sizes were adjusted in 36.8% of cases• All size changes were to the femoral implant – 13/14 were to
decrease size• Pre-op plan adjusted in 86.8% of cases• Combined RMS changes of 2.0 mm and 2.1 degrees to the femoral
component, and 0.9 mm and 1.4 degrees to the tibial component• No predictable changes in direction or magnitude
Impact:• Measurement and knowledge of the patient’s soft tissue envelope
allows for significant changes to the implant plan prior to any bony cuts.
• Surgical planning of UKA components based on accurate 3D reconstructions of anatomy alone (PSI and custom implant technology) is not adequate to create optimal implant gap spacing and contact kinematics throughout flexion.
Intra-operative flexibility is crucial for UKA implant planning
Intra-Operative Assessment of the Soft Tissue Envelope is Integral to the Planning of UKA Components. Roche MW, Branch S, Lightcap C, Conditt MA. 28th Annual Congress of ISTA, September 30- October 3, 2015; Vienna, Austria.
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Allows Me a more Mobile Window / Muscle Sparing Approaches
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Precision Implantation
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My Lateral Uni Execution Improved
Ability to internally rotate tibia to improve tracking through “screw home” mechanism
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Consistent Tracking and Congruency through ROM
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“Eureka learning curve” –efficiency program to prevent this
119 total cases40 min steady state timeLearning curve: 16 cases
70 total cases43 min steady state timeLearning curve: 29 cases
68 total cases58 min steady state timeLearning curve: 5 cases
Methodology:
• 892 patients received Mako UKA by 11 different surgeons
– Each surgeon had performed at least 40 cases
– Surgical time of the final 20 surgeries of each surgeon was averaged for a steady state surgical time
Results:
• Average surgical time for all surgeries across all surgeons: 56 ± 20 min
– Shortest steady state surgical time: 39 ± 9 min
– Longest steady state surgical time: 64 ± 16 min
• # of surgeries to have 2 consecutive surgeries completed within the 95% CI of the steady state surgical time: 16 (range: 4 to 42)
• # of surgeries to complete 3 total surgeries within the 95% CI of the steady state surgical time: 13 (range: 5 to 29)
• Skin to skin time decreased by 20+ min for surgeons who performed 4+ cases per month
Robotic-Arm Assisted UKA Shows Reasonable Average Learning
Curve
The Learning Curve of Robotically Assisted UKA. RH Jinnah, SH Branch, T Erdos, M Conditt . 23rd Annual SMIT Conference, September 13-16, 2011; Tel Aviv, Israel.
Skin to skin time decreased by 20+ min for surgeons who perform 4+ cases/month
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Unicompartmental knee arthroplasty: Is robotic technology more accurate than conventional technique? Citak M; Suero EM; Citak M; Dunbar NJ; Branch SH; Conditt MA; Banks SA; Pearle AD. The Knee. November 2012.
Accuracy of Dynamic Tactile-Guided Unicompartmental Knee Arthroplasty. Dunbar, NJ; Roche, MW; Park, BH; Branch, SH; Conditt, MA; Banks, SA. Journal of Arthroplasty. May 2012. 27(5): 803-808.e1.
Robotic-Arm Assisted Unicompartmental Knee Arthroplasty Lonner, JH. Seminars in Arthroplasty. 2009. 20(1): 15-22.
Robotic Arm-Assisted UKA Improved Tibial Component Alignment: A Pilot Study Lonner, JH; John, TK; Conditt, MA. Clin Orthop Relat Res. July 2009. 468(1): 141-6.
Robot-Assisted Unicompartmental Knee Arthroplasty Pearle, AD; O’Loughlin, PF; Kendoff, D. The Journal of Arthroplasty. December 2008. 25(2): 230-7.
Outcomes of Robotically Assisted Unicompartmental Arthroplasty Sinah, RK. American Journal of Orthopedics. 2009. XXXVIII(2S): 20-22.
Studies have shown: Robotic-Arm Assisted UKA is 2 to 3 times
more accurate and 3 times more reproducible than manual UKA
Mako MakoMako
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Methodology: • 139 patients enrolled in an RCT to receive Mako MCK UKA or manually
instrumented mobile bearing UKA• Endpoints of alignment, pain relief, functional return, activity level,
satisfaction, QALY, cost of care
Key Results:• Accuracy: Mako placement was significantly more accurate than manual
placement in all 3 rotational degrees of freedom for both the femoral and the tibial components (p<0.01)
• Mako patients reported significantly lower post-operative pain levels compared to manual patients from Day 1 to Week 8 (p<0.05)
• Almost twice as many Mako patients scored in the “Excellent” category of the American Knee Society Score (AKSS) at 3 months post-operative (57% vs 31%)
• At 1 year follow-up, ceiling effect seen with PROMs. Regression analysis revealed pre-op UCLA Activity Score >5 was a predictor of good clinical outcome• When removing the sedentary patients, the Mako group exhibited greater
AKSS (p<0.01), greater Oxford Knee Score (p<0.05) and greater Forgotten Joint Score (p<0.05)
• Mako UKA saved 54 bed days per 100 patients, with the resultant savings of ₤29,700 ($46,500) per 100 patients
Robotic Assisted vs Traditional Manual UKA: A randomised controlled trial. Blyth MJ; Jones B; MacLean A; Anthony I; Rowe P; World Arthroplasty Congress, April 15-18, 2015, Paris, France.
®
Robotic-Arm Assisted UKA resulted in lower pain and more
accurate placement than manual UKA: An RTC
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99.6% Survivorship Rate at 2 years
• 1/224 reported revision
– Revised to TKA at 12 months post-op due to mechanical loosening at tibial interface.
Does It makes a difference?
Swedish Registry 2 year revision rate: 4.5%
Australian Registry 2 year revision rate: 4.8%
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1.2%
4.0%4.4%
4.9%
6.1%
4.1%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
CRR for UKA at 2 yr f/u – National Joint Registries
Methodology:
• 797 patients (909 knees) from 6 surgeons were enrolled, with follow-up at a minimum of two years.
• Patients were recruited from a consecutive series for each surgeon starting with their initial Mako MCK patient.
• Mako system learning curve for 3 surgeons
• Implant learning curve for all 6 surgeons
• Varying surgeon volume: 4.6/month to 15.8/month
Key Results:
• Average follow up: 29.6 months (range: 22-52 months)
• 11/909 reported revisions 1.2% cumulative revision rate
• Kaplan-Meier survivorship rate at 2 years: 99.1%
• Revision rate in this series is 3 times less than cohort data and over 4 times less than registry data .
• This study is the largest multi-surgeon, multicenter cohort study in the literature.
• 0.49 revisions per 100 observed component years = 0.49% annual revision rate
• Pooled registry data for UKA = 1.65% annual revision rate (Pabinger et al. 2013)
• 92% of Patients are Very Satisfied/Satisfied with Mako UKA.
Impact:
• UKA is cost effective compared to TKA if annual conversion rate is <4% in 78yo patients
(Slover et al. 2007).
• UKA is cost effective compared TKA and HTO if the annual conversion rate is
<2% in 50-60yo patients (Konopka et al. 2015).
Short to Mid Term Survivorship of Robotic Arm Assisted UKA: A Multicenter Study. Coon T; Roche M; Dounchis J; Borus T; Buechel F; Pearle A. ICJR Pan Pacific Congress, July 16-19, 2015; Hawaii.
Mako Partial Knee Showed Low Revision Rate Out to 2 Years, High
Patient Satisfaction
Age Group
Knees Enroll
ed
Avgf/u
(mo)Revisio
ns
Total Observed Yrs
Rev/100 Comp
Yrs
≤60 145 29.2 3 353 0.85
60-70
312 29.0 4 753.8 0.53
70-80
312 30.3 3 785.6 0.38
≥80 139 30.0 1 347.4 0.29
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5 yr Data – 100 consecutive medial Uni’s
Pre-op5 yr post-op:
No lateral disease progressionMedial Alignment maintained
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• Robotic-Arm Assisted UKA shows excellent survivorship at 2 and 5 years post-op.
• Dynamic Intra-operative Adjustments allow an individualized approach.
• Intra-operative accuracy achieved with Robotic Arm Assisted UKA may lead to enhanced patient outcomes.
Conclusions
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The data included in this presentation was collected and is owned by the surgeon author of this presentation. The opinions expressed by Martin Roche, MD during this presentation are those of Martin Roche, MD and not necessarily those of Stryker.
