2/23/2016. Robotic Technology A Vision For The Future. David Jacofsky, MD Chairman The CORE Institute

Transcription

1 2/23/2016 Robotic Technology A Vision For The Future David Jacofsky, MD Chairman The CORE Institute 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. 1

2 2/23/2016 "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 "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. "I think there is a world market for maybe five computers. Thomas J. Watson, chairman of IBM, on seeing the first mainframe computer in

3 In Thousands In Thousands 2/23/2016 "There's no chance that the iphone is going to get any significant market share. Steve Ballmer, USA Today, April 30, 2007 Clinical Challenge Cardiac & Orthopedic Markets 23% decrease +600% Growth in Knee Replacement +200% Growth in Hip Replacement 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, Circulation. 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). 9 3

4 2/23/2016 Service Line Growth Forecast Business Challenge 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. 4

5 2/23/2016 Examples of where robots are better than humans etc. 5

6 2/23/2016 Robotic Technology Deliver and move merchandise. Make burgers. Fly planes. Drive farm equipment. Replace cashiers. Make iproducts. 6

7 Procedures Performed Systems Installed 2/23/2016 What is the point of the Mako System? 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. Illgen 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 & Efficiency Bragdon 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. Mako System Growth 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2, Mako systems in U.S. Over 60,000 procedures completed (uni+hip) 44 Published Peer-Reviewed Clinical Articles Abstracts 70 Ongoing Clinical Trials Acquired by Stryker Dec ~ $1.65B Total HIP Partial Knee OR Systems Installed

8 2/23/2016 For Me: Questions to Consider Over Time 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? My Vision of The Possible Future 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 Example Case Incision Complete exposure and registration Robotic-arm assisted cutting completed Implants and closure 40 minute turnover time 8

9 2/23/2016 OR 1 OR 2 OR 3 OR 4 Managing Your Innovation Portfolio, Harvard Business Review, May 2012, Nagji and Tuff 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. 9

10 2/23/2016 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. Questions?... 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 Prince

11 2/23/2016 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. 11

12 2/29/2016 Hip replacement using Mako Robotic-Arm Assisted Surgery My experience Joseph Nessler MD Saint Cloud Orthopedics Sartell MN, USA Saint Cloud Surgical Center Saint Cloud MN, USA Consultant, Stryker Disclaimer: The opinions expressed by Joseph Nessler, MD during this presentation are those of Joseph Nessler, MD and not necessarily those of Stryker. Complications in total hip arthroplasty Short term Dislocation is the leading short term complication for total hip replacements 1 -- national average is around 2.5% 1 Leg length discrepancy Long term Implant loosening Accelerated wear 2 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 3 1

13 2/29/2016 Malpositioned acetabular cups About 50% of acetabular cups are malpositioned according a recent paper published from Massachusetts General Hospital 2 4 Implant alignment/balancing options - my journey Conventional techniques Manual alignment guides Advanced alignment tools Navigation systems Precision surgical assistance 2015-present Mako Total Hip and Partial Knee 5 Predictable 6 2

14 2/29/2016 Pre-operative planning 7 Pre-operative planning 3-D view X-ray view 8 Intraoperative registration 9 3

15 2/29/2016 Intraoperative registration 10 Guided single stage reaming 11 Guided single stage reaming 12 4

16 2/29/2016 Robotic-arm assistance 13 Robotic-arm assisted cup placement Measures: inclination, version and depth to seating Auditory, visual and tactile feedback Fluctuation of Cup Orientation During Press-Fit Insertion: A Possible Cause of Malpositioning Takashi Nishii, MD, Takashi Sakai, MD, Masaki Takao, MD, Nobuhiko Sugano, MD Received: December 30, 2014; Accepted: April 27, 2015; Published Online: May 05, 2015, JOA 14 Pre-op planning compared to post-op 15 5

17 2/29/2016 Predictable 16 My experience to date 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 minutes, avg. ~ 40 minutes Outpatient center experience: Six-months of use Five surgeons using Mako Six trained Second Mako System purchased and in use 17 My reasons to believe in the technology 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 18 6

18 2/29/2016 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: 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): 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. 20 7

19 2/25/2016 Clinical Results with Mako Robotic-Arm Assisted Surgery for UKA Dr. Martin Roche 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? 1

20 2/25/2016 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 My Top Reasons to Use Robotic Technology 2

21 2/25/2016 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: Forgotten Joint Score 64 robotic-arm assisted medial UKR 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 ± 29.5 (p<0.05) Traditional PROMs did not show any significant differences between the groups UKA 59.3 TKA Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty: Are We Able to Create the Forgotten Joint. Pearle AP, et al,. 14 th Annual CAOS Meeting, June18-21, 2014, Milan, IT. UKA is more cost effective than TKA in patients over 65 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 postoperative 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) Effect of Age on Cost effectiveness of UKA vs TKA in the US. Pearle A, Ghomrami H. J Bone Joint Surg Am. 2015; 97: Robotic- Arm Assisted UKA Patients Return to Function More Quickly than TKA Patients 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 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 Extension (5) Flexion (115) Ext/Flex Strength TKA UKA p-value 5 ± 2.4 ± p= ± 3.8 ± p= ± 6.4 ± p= 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 Gait w/o AD Stair Ascend/Descend All Criteria 6.8 ± ± ± ± ± ± 1.9 p= p= p=0.183 UKA Patients Return to Function Earlier than TKA Patients. Borus T; Roberts D; Fairchild P; Christopher J; Conditt M; Matthews J. 27 th Annual Congress of ISTA, September 15-27, 2014; Kyoto, Japan. 3

22 2/25/2016 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 My Manual Approach Inconsistent Outcomes Pre-op Planning is Patient Specific CT Scan Based Technology (screen shot femur/tibia) (screen shot implant(s) in femur/tibia) 4

23 2/25/2016 Helps to Define Alignment Pre-Cut and Adjust Implants to Achieve Surgical Goals Helps to Define Gaps and Kinematics Intra-operative flexibility is crucial for UKA implant planning 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 Assessment of the Soft Tissue Envelope is Integral to the Planning of UKA Components. Roche MW, Branch S, Lightcap C, Conditt MA. 28 th Annual Congress of ISTA, September 30- October 3, 2015; Vienna, Austria. 5

24 2/25/2016 Allows Me a more Mobile Window / Muscle Sparing Approaches Precision Implantation 6

25 2/25/2016 My Lateral Uni Execution Improved Ability to internally rotate tibia to improve tracking through screw home mechanism Consistent Tracking and Congruency through ROM Robotic-Arm Assisted UKA Shows Reasonable Average Learning Curve Methodology: Skin to skin time decreased 892 patients received Mako UKA by 11 different surgeons by 20+ min for surgeons Each surgeon had performed at least 40 cases who perform 4+ Surgical time of the final 20 surgeries of each surgeon was averaged for a cases/month 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 119 total cases 40 min steady state time Learning curve: 16 cases 68 total cases 58 min steady state time Learning curve: 5 cases 70 total cases 43 min steady state time Learning curve: 29 cases Eureka learning curve efficiency program to prevent this The Learning Curve of Robotically Assisted UKA. RH Jinnah, SH Branch, T Erdos, M Conditt. 23 rd Annual SMIT Conference, September 13-16, 2011; Tel Aviv, Israel. 7

26 2/25/2016 Studies have shown: Robotic-Arm Assisted UKA is 2 to 3 times more accurate and 3 times more reproducible than manual UKA Mako Mako 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 Accuracy of Dynamic Tactile-Guided Unicompartmental Knee Arthroplasty. Dunbar, NJ; Roche, MW; Park, BH; Branch, SH; Conditt, MA; Banks, SA. Journal of Arthroplasty. May (5): e1. Robotic-Arm Assisted Unicompartmental Knee Arthroplasty Lonner, JH. Seminars in Arthroplasty (1): Robotic Arm-Assisted UKA Improved Tibial Component Alignment: A Pilot Study Lonner, JH; John, TK; Conditt, MA. Clin Orthop Relat Res. July (1): Robot-Assisted Unicompartmental Knee Arthroplasty Pearle, AD; O Loughlin, PF; Kendoff, D. The Journal of Arthroplasty. December (2): Outcomes of Robotically Assisted Unicompartmental Arthroplasty Sinah, RK. American Journal of Orthopedics XXXVIII(2S): Robotic-Arm Assisted UKA resulted in lower pain and more accurate placement than manual UKA: An RTC 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. Does It makes a difference? 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. Swedish Registry 2 year revision rate: 4.5% Australian Registry 2 year revision rate: 4.8% 8

27 2/25/2016 Mako Partial Knee Showed Low Revision Rate Out to 2 Years, High Patient Satisfaction 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: 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 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). 7.0% 6.0% 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% Age Gro up CRR for UKA at 2 yr f/u National Joint Registries 1.2% Knees Enroll ed 4.0% Avg f/u (mo) 4.4% Revisio ns 4.9% Total Observ ed Yrs 6.1% Rev/10 0 Comp Yrs % 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. 5 yr Data 100 consecutive medial Uni s Pre-op 5 yr post-op: No lateral disease progression Medial Alignment maintained Conclusions 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. 9

28 2/25/2016 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. 10