Advancing TJA Syllabus
2015-03-04
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3/3/2015 SENSOR ASSISTED SURGERY A Universal Solution to Customized Soft Tissue Balance “You can’t change what you can’t measure” Martin W. Roche, MD DISCLOSURES • OrthoSensor Inc: (Royalties, Board Member) • Stryker-MAKO, Inc: ( Royalties) SURGEON POLL (VuMedi 2015) 1 3/3/2015 WHAT DO WE WANT TO CHANGE ? • • • • • Reduce Rev TKA Burden Mal-rotation Mal-alignment Soft tissue Imbalance Patient Dissatisfaction DRIVE TOWARDS A DEFINITION of “ KNEE BALANCE” SENSOR MULTIFUNCTIONALITY allows DYNAMIC INTRA-OP KINETIC ASSESSMENT INTRA-OP SCENERIOS • Soft Tissue Asymmetry and Imbalance • Selective Soft Tissue Releases • Implant Congruency and Mal-rotation • Relation of “Balance” and Alignment Adjustments • Effects of Cementing Techniques 2 3/3/2015 PIE-CRUSTING MCL ROTATION Importance of Proper Tray Rotation • Retrospective analysis (n=170): 53% exhibited asymmetrical tibiofemoral congruency (68% IR, 32% ER) • 1000+ CT scans: exhibited the mid-medial 1/3 of the tibial tubercle can vary by ( ± 25°) • Inter-compartmental balance can be achieved by adjusting tibiofemoral congruency Roche M et al. The Relationship of the Medial 1/3 of the Tibial Tubercle to the Posterior Aspect of the Tibia, Holy Cross Hospital, Ft. Lauderdale, FL VALGUS KNEE Concerns: • Contracture / Recurvatum • MCL Stability • Femoral Rotation • Extra-articular Deformity 3 3/3/2015 EFFECTS OF ALIGNMENT PCL (POSTERIOR MEDIAL STABILIZER) 4 3/3/2015 CEMENTING TECHNIQUES PATIENT REPORTED OUTCOMES *Gustke et al. Primary TKA Patients with Quantifiably Balanced Soft-Tissue Achieve Significant Clinical Gains Sooner than Unbalanced Patients. Advan Orthop.2014 PATIENT SATISFACTION Prospective Data Collection Balanced satisfaction: 96.7% Unbalanced satisfaction: 82.1% Meta-Analysis • 12 papers met inclusion criteria (B-F = 3.048; homogeneity < 0.001; df = 11) • 81% average (“satisfied” to very satisfied”) 5 3/3/2015 CONCLUSIONS • Ligament Balance continues to be the most significant factor impacting patient outcomes • Functional improvement and satisfaction scores for unbalanced patients at 1-year were inferior to those achieved by balanced patients at 6-months • Sensor-assisted TKA patients are statistically more likely to achieve reduced pain, improved function, and greater activity levels than unbalanced patients • Patient Satisfaction scores for balanced patients show much larger improvement than unbalanced patients 6 3/3/2015 Improving Accuracy & Intelligence with Navigation in Total Knee Arthroplasty VuMedi Webinar Advancing TJA with Computer Technologies Paul K. Gilbert, MD Clinical Assistant Professor Keck Medical Center of USC Huntington Memorial Hospital, Pasadena, California March 3, 2015 General Ortho/subspecialty in joints 25 years in community private practice Recently joined USC part time Started doing CAS for hips and knees in 2004 400 robotic unicompartmental knees Accelerometer based tools Disclosures • Teaching/research consultant for Stryker/Mako Orthopaedics 3 1 3/3/2015 Why did I start? • Accuracy, the biomechanical sweet spot • Better functional outcomes • Happier patients • Less bleeding, fat emboli • Less revisions The Literature • Implant malalignment and malposition are associated with decreased function and/or higher revision rates • Navigated TKA results in better alignment and position • Navigated TKA data does not show improved functional outcomes Pros and Cons • • • • Less blood loss Less thromboembolism Less cognitive changes Promotes teamwork and staff satisfaction • Fractures associated with pin sites • Pin site infections • Cost • Time • Learning curve • Vascular injury 2 3/3/2015 Patient Satisfaction 80% What makes a good TKA? Pre-op: evaluate, optimize, educate, educate, educate Surgery: Post-op: rehab, hand holding, rehab, rehab Physical Therapists Pain management docs Patients feel they got the best Surveys 3 3/3/2015 December 2, 2011 2014 Australian Joint Registry December 2, 2011 2014 Australian Joint Registry Accuracy and Intelligence Thank you very much 4 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Patient Specific Instruments: Where Are We Now? Adolph V. Lombardi, Jr., MD, FACS Joint Implant Surgeons, Inc.; White Fence Surgical Suites; The Ohio State University; Mount Carmel Health System New Albany, Ohio Adolph V. Lombardi, Jr. Disclosure Consultant, Speaker’s Bureau: ♦ Biomet, Inc.; Pacira Royalties: ♦ Biomet, Inc.; Innomed, Inc. Research Support: ♦ Biomet, Inc.; Stryker; Pacira; Kinamed Publications Editorial Boards: ♦ Journal of Arthroplasty; Journal of Bone and Joint Surgery - American; Clinical Orthopaedics and Related Research; Journal of the American Academy of Orthopaedic Surgeons; Journal of Orthopaedics and Traumatology; Surgical Technology International; The Knee Boards: ♦ Operation Walk USA; The Hip Society; The Knee Society; Mount Carmel Education Center at New Albany 1. PSI has a 2-decade history. 1 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 History of Technology Radermacher 1994 Materialise, founded 1990 • Mimics and Magics software released 1991, 1992 Kinamed, since 1995 ConforMIS, founded 2004 OtisMed, founded 2005 2. PSI are based on a proven technology – Rapid Prototyping. 2 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Studies of Custom Triflange Components in Revision THA Authors (Country) Christie et al. (US) [6] # of Males: Mean Type of Acetabular Patients Females Age Defect (Hips) (years) 76 (78) 20:56 59 AAOS types III/IV Colen et. al (Belgium) [7] 6 (6) 3:3 69 AAOS types III/IV DeBoer et al. (US) [10] 18 (20) 3:15 56 Pelvic discontinuity Holt et al. (US) [12] 26 (26) 8:18 69 Paprosky type 3B; AAOS types III/IV Joshi et al. (US) [13] 27 (27) 9:18 68 AAOS type III Taunton et al. (US) [25] 57 (57) 6:51 61 Pelvic discontinuity Wind Jr. et al. (US) [27] 19 (19) 7:12 58 Lombardi et al. CORR (in submission) 26 (28) 7:19 68 Paprosky types 3A/3B; AAOS types III/IV Paprosky type 3B Observation Time Results Surgeries 1992-1998; 6 reoperations for recurrent Mean f/u 53 months dislocation (7.8%); no removal of triflange components. Pre-op HHS: 33; Post-op HHS: 82 Surgeries 2007-2011; 0 revisions. Mean f/u 28 months Post-op HHS: 61 Surgeries 1992-1998; Mean f/u 123 months Mean f/u 54 months 6 revisions (30%); no removal of triflange components. Pre-op HHS: 41; Post-op HHS: 80 3 failures of triflange components (11.5%). Pre-op HHS: 39; Post-op HHS: 78 Surgeries 1993-1996; 2 revisions with removal of Mean f/u 58 months triflange components (7.4%). Surgeries 1992-2008; 20 revisions for any reason (35%); 3 Mean f/u 76 months failures of triflange components (5.3%). Post-op HHS: 75 Surgeries 2001-2005; 2 revisions for failure of triflange Mean f/u 31 months components (10.5%). Pre-op HHS: 38; Post-op HHS: 63 Surgeries 2003-2012; 4 revisions for any reason (14%); 2 Mean f/u 47 months failures of triflange components due to infection (7.1%). Pre-op HHS: 42; Post-op HHS: 64 US=United States; f/u=follow-up. 3. PSI are offered by multiple orthopaedic manufacturers. 3 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Current TKA Platforms for Patient Specific Alignment Guides Manufacturer Product Imaging US Launch Signature™ MRI CT CT 10/2007 01/2010 2011-2012 Trumatch™ CT 04/2009 MyKnee® CT or MRI 04/2010 Smith & Nephew Visionaire™ MRI & X-ray 11/2008 MicroPort* Prophecy™ CT or MRI 03/2009 PSI MRI CT 11/2009 06/2012 Biomet iTotal® ConforMIS DePuy Medacta Zimmer *formerly Wright Medical 4. PSI are expanding: UKA THA TSA TA Osteotomy alignment correction 4 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Current PSI Platforms for UKA Manufacturer Product Imaging US Launch Biomet Signature™ MRI 10/2011 Zimmer PSI MRI CT 02/2012 10/2012 PSI for Acetabular Positioning PSI for Shoulder Component Positioning 5 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 The patient receives a CT scan following the protocol. Virtual preoperative alignment is performed according to surgeon preferences. The surgical plan is approved via website. The surgeon may alter the plan if desired. 3/3/2015 Surgery is performed in accordance with the preoperative plan. A rapid prototyping machine produces patient-specific guides out of high resolution nylon. Guides are then sent out for surgery. Pre-Op Post-Op Victor & Premanthana, BJJ 2013 5. PSI utilization is increasing throughout the world 6 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Numbers of PSI TKA, 2011-2012 Manufacturer Biomet Global 2011 11,192 Europe 2011 3,169 Global 2012 22,506 Europe 2012 6,501 DePuy-Synthes 6,000 700 16,000 1,100 Medacta 4,600 3,400 6,200 4,600 Smith & Nephew 19,500 1,825 22,000 2,614 Wright Medical 1,600 400 2,000 550 Zimmer 9,800 1,250 13,850 2,150 Thienpont et al., KSSTA 2013 6. PSI are extremely useful in patients with extra-articular deformity or retained hardware. 7 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 7. PSI have been used successfully in revision knee arthroplasty. 8 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 8. PSI facilitate preoperative planning. 9 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 9. PSI offer distinct advantages to lower volume surgeons. With a 6-fold increase in the incidence of TKA projected over the next 2 decades, an increasing burden on lower volume/inexperienced arthroplasty surgeons, who tend to have longer operative times and increased complication rates compared with high-volume surgeons, is expected. Improved efficiency and reproducibility in implant positioning and limb alignment is paramount to decreasing complications, improving outcomes, and meeting the increasing demand. Patient-customized cutting guides that are being developed by most major manufacturers of total knee prostheses are an emerging technology that will allow the lower-volume surgeon to meet many of these demands. One of the primary drivers of increased surgical times for lower-volume surgeons is the significant number of steps and complexity of instrumentation required to perform a TKA. The use of CPI eliminates numerous steps in the surgical technique and eliminates the need for as many as 80 instruments, which allows for significantly improved surgical efficiency. The elimination of this instrumentation also allows for significant improvement in processing and operating room efficiency with decreased incidence of processing error. The 31-minute decrease in operating room set-up and breakdown in the study reported here was realized by an operating room staff who is very experienced with TKA. A greater improvement in efficiency may be realized by a lower volume operating room staff. Johnson, AJO 2011 10. PSI require less instrumentation resulting in less OR time setup and breakdown, a decrease in the number of instruments requiring sterile processing. 10 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Traditional Setup PSI Setup 11. PSI easily fit into the operative workflow, and in the majority of timed studies actually decrease operative time. 11 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 PSI Workflow Value of PSG in TKA Significant reduction in: ♦ Processing and sterilization time ♦ Turnover time ♦ OR time ♦ Number of trays used ♦ Hospital stay Noble et al., J Arth 2012 Johnson, Am J Orthop 2011 Duffy, Am J Orthop 2011 Lionberger et al., AAHKS 2011 Nunley et al., CORR 2011 Tibesku et al., AOTS 2013 12. PSI has more supportive literature than negative literature. 12 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Patient Specific Guides - Pro Barrett et al., J Arth 2014 Boyd et al., Clin Sports Med 2014 Cenni et al., J Ortho Res 2014 Ensini et al., KSSTA 2014 Marimuthu et al., J Arth 2014 Silva et al., KSSTA 2014 Bonicoli et al., Eur J OST 2013 Chareancholvanich et al., BJJ 2013 Daniilidis & Tibesku, Int Orthop 2013 Issa et al., J Knee 2013 Kerens et al., Acta Orthop 2013 Koch et al., KSSTA 2013 MacDessi et al., The Knee 2013 Thienpont et al., The Knee 2013 Thienpont et al., KSSTA 2013 Tibesku et al., AOTS 2013 Volpi et al., KSSTA 2013 Yaffe et al., Int J CARS 2013 Ast et al., OCNA 2012 Bali et al., J Arth 2012 Boonen et al., Acta Orthop 2012 Heyse & Tibesku, The Knee 2012 Johnson, Am J Orthop 2012 Lombardi & Frye, CRMSM 2012 Nam et al., JKS 2012 Mayer et al., J Arth 2012 Ng et al., CORR 2012 Noble et al., J Arth 2012 Slammin & Parsley, CRMSM 2012 Yaffe et al., Biomed Tech 2012 Yeo et al., ISRN Orthop 2012 Stulberg et al., KS IM 2012 Mont et al., KS IM 2012 Duffy, Am J Orthop 2011 Johnson, Am J Orthop 2011 McGovern, Am J Orthop 2011 Watters et al., JSOA 2011 Lombardi et al., Orthopedics 2008 Patient Specific Guides – Con / Questionable Chen et al., KSSTA 2014 Conteduca et al., Int Orthop 2014 Scholes et al., KSSTA 2014 Victor et al., CORR 2014 Hamilton et al., J Arth 2013 Nam et al., The Knee 2013 Parratte et al., KSSTA 2013 Roh et al., CORR 2013 Stronach et al., CORR 2013 Barrack et al., JBJS Br 2012 Conteduca et al., KSSTA 2012 Conteduca et al., Int Orthop 2012 Lustig et al., J Arth 2012 Nam et al., J Arth 2012 Nunley et al., CORR 2012 Stronach et al., CORR 2012 Bellemans et al., KS IM 2012 13. PSI has been reported to be associated with significant improvement in Knee Society Functional Score in short-term follow-up. 13 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 Yaffe et al., Int J CARS 2013 14. PSI technology is in a state of constant evolution – Now based on preoperative CT/MRI and moving in the direction of preoperative x-rays only. X-Ray based 3D Planning Procedure Specific Kits Core Set of Reusable Instruments 2D X-Ray to 3D Shape Model Full Automation Rapid Turn Around Cost Effective Guide Technology 14 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 3/3/2015 15. PSI are part of the future delivery of implants. Traditional Instrument/Implant Delivery System 1. 2. 3. 4. 5. 6. Orthopaedic Assessment Surgery Scheduled Orthopaedic Rep Contacted Physician/Rep Template Case Plan Developed Instruments/Implants Delivered to Hospital 7. Instruments Signed into Central Sterile 8. Implants Stored 9. Washer/Sterilizer Decontamination 10. Instruments Wrapped/Labeled Traditional Instrument/Implant Delivery System 11. Instruments Autoclaved 12. Case Cart Loaded 13. Delivered to OR 14. Trays Opened and Checked 15. Implants Inventory to Field 16. Trays Removed from Field Loaded on Cart 17. Preliminary Decontamination 18. Returned to Decontamination 19. Load Washer/Sterilizer 20. Organize Trays/Wrap/ Label 21. Autoclave Trays 20. Organize Trays and Lable 21. Autoclave 15 Lombardi Patient-Specific Instruments_VuMedi_3-3-2015.2 Traditional Re-Usable Cutting Blocks & Trials 3/3/2015 Sterile-Packed Single-Use Cutting Blocks & Trials Mont et al., J Arth 2013 The Future of Orthopaedic Implant Delivery Marrying PSG with single-use instruments streamlines the delivery of orthopaedic products Decreased number of instruments with SUI reduces: ♦ OR setup time ♦ OR turnover time ♦ Overall surgical time ♦ Infection? PSG and SUI increase efficiency Restoring mobility • Giving hope 16 3/3/2015 Patient Specific Instrumentation and Implants: Do They Significantly Impact Patient Satisfaction and Outcome? Brian S. Parsley, MD Clinical Associate Professor Director- Adult Reconstruction Fellowship Ryan Palmer, DO Adult Reconstruction Fellow Baylor College of Medicine Houston, Texas • Consultant for Nimbic Air Barrier System • Royalties from Conformis Inc. • AAHKS Board Disclosures Orthopaedist Love New Toys! 1 3/3/2015 New Technology for TKA- PSI • Rapid growth in the offerings of Patient Specific Guidance • Customized cutting blocks for knee replacements • Computer based guidance for hip and knee replacements • From simple to complex • Both imageless and image based • Individual vs robotically guided • Custom made implants for knee replacements • What is the justification? • Cost reduction? • Time Efficiency? • Patient outcomes? Let’s Look at Function • Patient Specific Instrumentation (PSI) vs. Conventional • 40 patients randomized into 2 groups; 20 each group • All pts received Zimmer NexGen LPS-Flex mobile cemented implants • Patients evaluated pre-operatively and 3 months post-operatively • New Knee Society Score [KSS], KOOS, SF-12, & Gait Analysis • Results: • In the PSI group, 25% of cases required intra-operative modifications • Overall, there were no differences in the new KSS, KOOS, or SF-12 between the PSI and conventional TKA groups (see graft) • Overall, there were no differences in the analyzed gait parameters between the two groups 2 3/3/2015 Comparison of Pre & Post Op Function Comparison of Pre & Post Op Gait • 3 complications in the PSI group • 2 patients had post-operative flexion contractures of 5 and 10 degrees • Both patients had pre-operative flexion contractures • 1 patient had pre-operative patellar subluxation that continued post-operatively • No complications in the conventional TKA group Complications 3 3/3/2015 Custom Cutting Guides Do Not Improve Total Knee Arthroplasty Outcomes at 2 Years Follow-up D. Nam, A. Park, J. Stambough, S. Johnson, R. Nunley, R. Barrack • 95 custom cutting guides vs. 95 conventional cutting guides for TKA by same surgeon • Patient self selection into either group • UCLA Score, SF-12, Oxford Knee & Forgotten Joint scores collected pre & postoperatively • Rotational alignment, Patient Satisfaction scores post-operatively, Presented at AAHKS Annual Meeting Nov. 2014 • No differences for range of motion, UCLA, SF-12, Oxford Knee, or Forgotten Joint scores between the two cohorts (p=0.09 to 0.76) • No differences were present for the incremental improvement in these scores from preoperatively to postoperatively (p=0.1 to 0.9) • No difference in mean tourniquet time (59.1 + 13.2 mins in CCG vs. 59.7 + 14.7 mins in standard cohort; p=0.75) • Percentage of outliers for overall mechanical alignment (31% in CCG versus 23% in standard cohort with HKA outside of 0° + 3°; p=0.2). Results Presented by Nam at AAHKS Annual Meeting Nov. 2014 • At two years follow-up, custom cutting guides fail to demonstrate any advantages in clinical outcomes versus the use of standard instrumentation in total knee arthroplasty. • The benefit of CCGs must be proven prior to continued implementation of this technology. Conclusions Presented by Nam at AAHKS Annual Meeting Nov. 2014 4 3/3/2015 • Do patient specific cutting blocks achieve neutral mechanical alignment more reliably during TKA when compared with conventional methods? • 16 studies, Level I-III evidence • Does patient-specific instrumentation (PSI) provide financial benefit through improved surgical efficiency? • 13 studies, Level I-III evidence • Does the use of patient-specific cutting blocks translate to improved clinical results after TKA when compared with conventional instrumentation? • 2 studies, Level III evidence Do Patient Specific Instrumentation Achieve Neutral Mechanical Alignment More Reliably? Variable Results From Improvement in Reduction in Outliers When PSI Used Do Patient Specific Instrumentation Achieve Neutral Mechanical Alignment More Reliably? To No Difference In Benefit 5 3/3/2015 Do Patient Specific Instrumentation Achieve Neutral Mechanical Alignment More Reliably? To The Reverse Effect with PSI Do Patient Specific Instrumentation Achieve Neutral Mechanical Alignment More Reliably? Conclusion: No Significant Difference Overall in Ability to Achieve Overall Alignment Does PSI Provide Financial Benefit Through Improved Surgical Efficiency? Minimal decrease in OR Time if any except one study (12min) and one at 10 min Frequent need to recut despite PSI Decrease in # of trays and cost associated Increase in cost associated with Custom Cutting Blocks and CT or MRI 6 3/3/2015 Does The Use of PSI Translate to Improved Clinical Results? No Difference in Functional Scores at Short Term Follow-up Limited number of studies available • Limited data exist with regard to the effect of PSI on post-operative function, improvement in pain, and patient satisfaction • Neither of the 2 studies evaluating clinical results provided strong evidence to support an advantage favoring the use of PSI • There is a need for Mid- and long-term data regarding PSI’s effect on functional outcomes and component survivorship • Short-term data scarce • Limited available literature does not clearly support any improvement of post-operative pain, activity, function, or ROM when PSI is compared with traditional instrumentation Conclusions • Retrospective case-control study • 122 Total Knee Arthroplasties by one surgeon • 44 with (PSI) vs 38 with Computer Assisted Surgery (CAS) vs 40 with manual instrumentation • Groups were identical with regard to age, gender, diagnosis, BMI, and perioperative management but had significantly different starting points 7 3/3/2015 Change in Score Pre to Post 33.8 43.0 36.7 NS Pre-operative and post-operative knees scores were higher in the PSI group. Similar improvements from pre to post-op. Bias? Lack of randomization? Skewed results? Pre and post-operative knee function scores were higher in the PSI group. PSI showed a higher function score improvement when compared to manual instrumentation (24.5 pts vs 3.8 pts) Bias? Lack of randomization? Skewed results? Change in ROM 1.5 1.3 2.4 Pre and post-operative range of motion was higher in the PSI group. The change in ROM between groups was no different. 8 3/3/2015 Change in pain score 30.7 26.4 26 Pre to post-operative knees pain score improvement was higher in the PSI group but the improvement within groups was similar. CAS showed a more varus mechanical axis compared to manual (2.00 degrees varus vs. 0.24 degrees valgus) No difference found in post-operative mechanical axis between PSI and CAS, or PSI and manual groups Conclusions • The PSI group showed greater improvement in Knee Society function scores over 6 months when compared to manual TKA • But the PSI group also had higher pre-operative function scores • Lack of randomization limits conclusions • No statistical differences seen in knee score, ROM, or pain score improvement from pre-operative to the 6-month post-operative period among all groups • No difference in mechanical alignment 9 3/3/2015 • • • • 62 patients Smith and Nephew Genesis II TKA Visionaire(31) vs Conventional(31) Randomized in 1:1 linear fashion Mean follow up: short- 200+days Results: • No statistical difference in Satisfaction • No statistical differences between pre-operative and post-operative KOOS scores • Total KOOS scores (see graft) • KOOS subscales (see graft) • No statistical differences in VAS scores Results • Flexion Contracture • Visionaire • 13/31 (43%) unable to obtain full extension post-operatively • Conventional • 6/31 (19%) • Strict adherence to pre-operative plan and cutting blocks as a cause of residual flexion deformity • Did not recut distal femur, followed planned resection • No statistically significant differences between groups for • Satisfaction, Pain scores, or Functional outcome scores • Gait, Flexion, EBL & transfusion needed, or alignment 10 3/3/2015 Biomet Signature PSI System • Average $4000 per standard Vanguard TKA hospital contract • General number in Houston, TX Medical Center region • Add approximately $950 upcharge for PSI creation with Signature system • Cost of MRI to create instrumentation-?? Cost • 248 TKA’s by one surgeon: 126 ConforMIS TKA vs. 122 Off-the-shelf (OTS) TKA • Retrospective review • Data collected: • • • • • Length of procedure, LOS, Transfusions, Cost, Disposition Presented at ICJR Pan-Pacific Meeting 2014 Results • Demographics, LOS: No statistical differences • Transfusion rates • Conformis showed significantly less (2.4% ConforMIS vs 10.7% OTS) • Adverse event rate • Conformis showed significantly less (1.6% ConforMIS vs 13.9% OTS) • Specific adverse events not published in abstract • Total hospital cost • Not statistically significant ($16,192 vs $16,240) • Discharge disposition • Significantly lower percentage of patients in the ConforMIS group were discharge to acute care facilities (ConforMIS 2.4% vs 13.9% OTS) Presented by Martin at ICJR Pan-Pacific Meeting 2014 11 3/3/2015 Presented by Martin at ICJR Pan-Pacific Meeting 2014 Conclusions • Significantly lower transfusion rates • Likely related to eliminating the need for intra-medullary guides • General estimated associated cost of $2200 per blood transfusion • Significantly lower reported adverse event rates • Specific adverse events not defined in abstract • Costs associated with these specific adverse events not know • Fewer patients discharged to acute care facilities with ConforMIS • Authors reasons for this not revealed • Criteria for discharge to acute care facility unknown • Estimated $16,000 per discharge to acute care facility • No statistical difference in overall hospital costs between the two groups Presented by Martin at ICJR Pan-Pacific Meeting 2014 PSI vs. OTS TKR vs. Custom TKR • Is the difference in the cutting blocks vs. the conventional cutting systems when an OTS type knee is still being used?? OR • Is it the combination of PSI and a custom patient specific TKR? 12 3/3/2015 In Conclusion • There is NO clear data that PSI demonstrates consistent improvement in function, ROM, alignment, or patient reported outcomes in the current literature. • The literature is limited and short term at this time. • The cost justification is lacking with few exceptions. • Should the Healthcare System be paying the bill? THANK YOU • 20 patients by single surgeon • 11 ConforMIS CR TKA • 9 Off-the-shelf (OTS) CR TKA (Zimmer NexGen) • Mobile fluoroscopic system used to analyze knee motion • Deep knee bend • Chair rise • Fluorscopic 2D images were converted into 3D representation of kinematics • Comparison of kinematics • ROM • Posterior femoral rollback • Axial rotation Presented at ICJR Pan-Pacific Meeting 2014 13 3/3/2015 Presented by Kurtz at ICJR Pan-Pacific Meeting 2014 Presented by Kurtz at ICJR Pan-Pacific Meeting 2014 Conclusions • Authors conclude ConforMIS TKA patients experienced a more normal kinematic pattern of the knee compared to an OTS TKA • OTS TKA experienced greater variability in kinematic patterns • No patient satisfaction or outcome scores reported • Do differences in kinematic patterns equate to improved patient satisfaction, function, or longevity of the implant? Presented by Kurtz at ICJR Pan-Pacific Meeting 2014 14 3/3/2015 Robotics in UKA: Latest Advances in Technique and Cost Efficiency Jess H. Lonner, MD Rothman Institute Associate Professor, Department of Orthopaedic Surgery Thomas Jefferson University Philadelphia, 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 Growing Use of UKA in US 1998-2005 UKA utilization increased 32.5% (vs TKA: 9.4%) Expanding use of early intervention strategies Improved surgeon education Better diagnosis Demographics- younger, employed, restless Riddle DL, Jiranek WA, McGlynn FJ. J Arthroplasty 2008 1 3/3/2015 Advantages of UKA vs TKA Tissue sparing Safer (Lower M &M) Rapid recovery More normal feel Greater functionability Less expensive Growing emphasis on outpatient surgery UKA: 94% survivorship at 10-15 yrs in hands of high volume surgeons… …But > Age 65 < Age 65 10-yr survivorship 77% 7-yr survivorship 74% Ong, Lonner etal AAHKS 2014 2 3/3/2015 What Impacts the Results of UKA? Pathology/Disease Patient selection Component design Polyethylene quality Surgeon experience/volume Accuracy of implantation Malalignment Predisposes to Failure Coronal malalignment of tibial component >3° varus Mechanical limb varus >8° Posterior tibial slope >7° Collier /Engh et al. J Arthroplasty 2006; Hernigou JBJS 2004; Chatellard Orthop Traumatol Surg Res 2013 Outliers in Alignment in UKA with Conventional Methods 40-60% of cases are malaligned beyond 2° of plan Keene G et al JBJS Br 2006; Cobb J et al JBJS Br 2006 3 3/3/2015 Rationale of Robotics for UKA 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 Story of Robotics in UKA Study in patterns that define technological progress and innovation, in general Declining capital and maintenance costs Smaller space requirements Broadening access Increased utilization Expanding Role for Robotics in UKA 15% of UKA’s in US (2013) www.OrthopedicNetworkNews.com. 2013 4 3/3/2015 Semi-autonomous Robotics in UKA Mako (Mako Stryker, Ft. Lauderdale, FL) Initial FDA approval 2005; revised 2008 Image-based (CT scan) Navio PFS (Blue Belt Technologies, Plymouth, MN) Initial FDA approval 2012 Image-free 1st Generation Semi-Autonomous Robotic Arm for UKA: Mako* FDA clearance 2005 Haptic constraint Efficient Safe Image-based (preop CT scan) Closed system (metal backed, FB UKA) *Mako Stryker, Ft. Lauderdale, FL Alignment – UKA Conventional vs. Mako Robotic 2.6x more variability with manual techniques (p<0.05) Average error: Manual: 2.7 Robot: 0.2 (p<0.0001) (Lonner, John, Conditt CORR 2010) 5 3/3/2015 Mako Results vs Conventional UKA RCT, 100 patients Conventional Oxford UKA vs Robotic Mako Postop CT to assess coronal, sagittal, rot’l alignment Significantly less error in tibial slope, femoral v/v, tibial rotation (p<0.01) Blyth MJ et al. AAOS 2013 Downsides of 1st Generation Robotic System in US Capital expense Preop CT scan Additional expense Denials common; high copays; bundled payments Hospitals “eat cost” Time/Inconvenience Radiation exposure Closed platform 2nd Generation Robotic System: Navio PFS FDA clearance: 2012 Image-free (No CT scan) Intraop registration/mapping/planning Intraop gap balancing Semi-autonomous Burr Speed/Exposure control 6 3/3/2015 Navio Technique: Surface Mapping Dynamic Intraop Gap Balancing Selection of Implant Size/Position and Virtual Gap Balance 7 3/3/2015 Virtual Tracking of Femur on Tibia Technique: Exposure Mode Prepared Surface 8 3/3/2015 Data??? Key Studies Accuracy of bone preparation Comparison of intraoperative plan for limb alignment with postop limb alignment Accuracy of tibial component alignment Safety Radiation avoidance Pre-clinical (cadaveric specimens) Clinical (navigated measures) Radiographic Study 1: Pre-Clinical Accuracy 25 cadaveric specimens 3 surgeons Medial UKA (Tornier HLS Uni Evolution) Lonner, Smith, Picard, Hamlin - Clin Orthop 2014 9 3/3/2015 Analysis Method Preop plan Postop analysis Optical probe inserted into implant divots Surface positions mapped Postop position compared to plan Lonner, Smith, Picard, Hamlin - Clin Orthop 2014 Alignment: Vs. Other Semi-Autonomous (CT-based) Robots and Manual Acrobot Manual Flex/Ext (°) RMS Error NavioPFS Mako Rio 1.6 2.1 2.1 4.1 Varus/Valgus (°) 2.3 2.1 1.7 6.0 Int/Ext (°) 1.7 3.0 3.1 6.3 Prox/Dist (mm) Ant/Post (mm) 1.3 1.3 1.0 1.6 1.0 1.8 2.8 2.4 Med/Lat (mm) 0.9 1.0 0.6 1.6 Dunbar et al J Arthrop 2012 Cobb J JBJS Br 2005 Jenny J Arthrop 2002 Lonner et al CORR 2014 Study 2: Planned versus Achieved Limb Alignment 65 cases Multiple surgeons Postop limb alignment ≤1° from plan 92% (60/65) F Picard, A Gregori, J Bellemans, J Lonner, J Smith, D Gonzales, A Simone, B Jaramaz – CAOS July 2014 10 3/3/2015 Study 3: Safety of Hand-Held Robot Initial 1000 cases No soft tissue complications Study 4: Learning Curve Mean of 8 procedures (range 5-11) to reach a steady state surgical time. Mean steady state surgical time was 50 minutes (range 37-55 minutes) A Gregori, F Picard, J Bellemans, J Lonner, R Marquez, J Smith, A Simone, B Jaramaz CAOS Abstract 2014 Study 5: Avoidance of Radiation from preop CT Scans (Mako protocol) 236 scans 2011-2013 ED of radiation from LE CT scan: 4.8 +/- 3.0 mSv 25% had add’l CT scans (est cumulative ED of 6-103 mSv) Note: 10 mSv increases risk of fatal cancer by 1 in 2000 11 3/3/2015 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 Costs of Care (Partial Knees) Cohort Mean Hospital $16,495 (Inpatient) N=50 Hospital $13,295 (Outpatient) N=50 ASC $9,969 N=50 Min Max $12,784 $28,644 $7,249 $24,758 $3,406 $15,321 Uhr A, Davis D, Lonner J. 2015 Conclusion: Precise preoperative/intraop planning Surface mapping Gap balancing Accurate bone preparation, implant alignment, component positioning Enhanced early outcomes Impact on late results? Cost analysis 12 3/3/2015 Conclusion: 2nd Generation Robot Semi-autonomous system Image-free Cost favorable ASC-feasible Work flow intuitive Implant-specific vs open platform Expanding applications 13 3/3/2015 New Approaches: Robotics in THA Adam M Freedhand, MD Assistant Professor Disclosures • Stryker • Educational consultant • OrthoSensor • Stockholder What are we improving? i.e. Why robotics? Goals of THA Pain relief Restoration of Function Durable results • • • Implants Materials Approaches 1 3/3/2015 Areas of Improvement • Component / Mechanical failures • Product recalls • Surgical Complications THA Issues Lawsuits • Component Malposition • Leg length discrepancies • Instability/Dislocation Upadhyay, JOA 2007 Critical Factors Biomechanics/Kinematics • Implant Sizing • Implant Positioning • Fit • Alignment 2 3/3/2015 Component Malposition • Early • LLD/Dislocation • 4% • Late • Impingement/Wear • Loosening Component Malposition Acetabulum At Massachusetts General Hospital, only 36.9% of cups were in the desired zone of placement. Conventional Instruments Little Guidance • Manual instruments inconsistent • Outcomes depend on alignment • Acetabulum / Femur 3 3/3/2015 How Can We Improve? Low and High Tech • Surgical planning - template • Intra-operative X-ray • Alignment tools • CAS • Robotics Robotics • What’s available Think Surgical • • • • Since 1992 Femur Open platform Mako • • • Since 2006 Acetabulum Closed platform Robotics Advantages • Advanced surgical planning • Precise robotic machining of bone • Improved component placement • Know result before leaving the OR 4 3/3/2015 Mako / Think Surgical • Pre-operative CT scans • 3D virtual surgery • Intra-operative execution of plan • Optimize implant position • Improve outcomes? Accuracy and Precision Robot vs Manual Instruments 146 hips: 75 robot, 71 manual • Leg lengths more accurate • Slightly better JOA Clinical scores • Less stress shielding in the Robot Cohort 5 3/3/2015 Patient Outcomes Higher Harris Hip Scores, Lower Dislocation Rate Think Surgical THA Outcomes • Less fractures • Better fit/fill • Precise placement of the femoral component • Size, alignment, depth of seat Clinical Orthopaedics & Related Research: September 1998 - Volume 354 - Issue - pp 82-91 Symposium: Computer Assisted Orthopaedic Surgery: Medical Robotics and Image Guided Surgery Mako THA More Cups in the Safe Zone • Cup inclination/Version • <5˙ from plan • Acetabular COR • <2mm from plan 6 3/3/2015 Robotics in THA Workflow • 3D surgical plan • Exposure • Registration • Machining of the bone • Trial / Implantation • Closure Bone Registration • Mako • Pelvic array • Acetabulum and Femur checkpoints • Robodoc • Femoral head armature • CAS for acetabulum Robotic Bone Resection • Robodoc • Surgeon clears workspace • Active femur prep • Mako • Passive acetabular prep • Visual, tactile and audible feedback 7 3/3/2015 Surgeon's Role • Patient selection • Implant selection • Virtual Surgical Plan • Expose / Protect / Close tissues • Execute / Verify surgical Plan Robotics Not Experimental • Robodoc since 1992 • • • 60 units worldwide Over 30K casesHip/Knee Mako since 2006 • 29K cases- Knee/Hip Industrial Revolution Analogy Before: • Everything Handmade • Apprenticeship / Artisans • Variation in Quality After: • Mostly Machinemade • Quality Control • Minimize Human error and Outcome 8 3/3/2015 Robotic Surgical Revolution Before • • • • Surgeon Apprentices Apprenticeship / Artisans Conventional Instruments The Future is now! • • • CAS/Robotics for precision and accuracy Quality Control Minimize Surgical error Variation in Quality and Outcome 9
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