12 14 16 Robotic Spine Syllabus
2016-12-15
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12/14/2016 Robotic Spine Surgery Introduction and Literature Review Christopher R. Good, MD, FACS Director of Research Director of Scoliosis and Spinal Deformity Surgery Advancements in Robotic Spine Surgery Agenda • History of Robotic Surgery and Literature Review • Christopher R, Good MD, FACS • Minimally Invasive Robotic Spine Surgery • Michael Wang, MD, FACS • Robotic Spinal Deformity Surgery • Ronald Lehman, Jr, MD • Robotic Assisted Spinal Tumor Resection • Samuel Bederman, MD • Robotic Sacroiliac Joint Fusion • Bernard Guiot, MD • The Future of Robotic Spine Surgery • Christopher R, Good MD, FACS Disclosures Consultant Mazor Robotics Consultant /Travel Reimbursement MOI: $1000-$10,000 I use “guidance” in ~ 30% of my cases First Robot Experience - 2005 First Navigation Experience - 2007 Regular use Navigation -2010 Regular use Robot- 2012 1 12/14/2016 Robotic Spine Surgery History and Literature Review Agenda Robotic Surgery Background “How it Works” for Spine surgery Case Examples Open Deformity MIS Deformity Literature Potential advantages Potential Weaknesses 2 12/14/2016 Robotic-Guided Spine Surgery Posterior approaches (Open, MIS, Percutaneous) Spinal fixation ─ Pedicle screws ─ Transfacet, translaminar-facet screws ─ Sacroiliac screws Spinal deformities ─ Scoliosis posterior spinal instrumentation Cement augmentations ─ Kyphoplasty and vertebroplasty Oncological applications ─ Biopsies, tumor resections Revision Surgery 7 Robotic-Guided Spine Surgery Guidance Unit Planning Software Workstation Robotic-Guided Spine Surgery Pre-op 3D planning 3 12/14/2016 Robot Registration Process Pre-op CT vs intra-op CT “scan and plan” 10 Robot mounted to patient via bone Robot Positioning Near Patient Reference Arc 4 12/14/2016 Robotic-Guided Scoliosis Correction Cortical Pedicles, Severe Osteoporosis Progressive Deformity, PFTs 47% predicted T3 L3 Robotic-Guided Scoliosis Correction Cortical Pedicles, Severe Osteoporosis Progressive Deformity, PFTs 47% predicted 5 12/14/2016 MIS Deformity Template skin incisions 6 12/14/2016 •130 studies – 37,337 pedicle screws (cadaver and in vivo) •91% accuracy overall •Navigation – 95.2% •No Navigation – 90.3% n=3,059 n=12,299 • 30 studies • 1973 patients - 9310 pedicle screws • Results consistent throughout all spinal levels Type Data sets Total screws Accurate screws % accurate Conventional fluoroscopy 12 3719 2532 68.1 2D fluoroscopic navigation 8 1223 1031 84.3 3D fluoroscopic navigation 20 4368 4170 95.5 7 12/14/2016 •Retrospective review •Radiographs (all) and CTs (646 screws) •635 cases in 14 medical centers •49% of implants placed percutaneously •98.3% Accuracy of 3,271 implants •CT data •98% safe (<2mm) •89% contained 22 Retrospective: 112 cases Robot vs freehand •Improved implant accuracy • 94% vs 91% •Reduced fluoroscopy by 56% • 34 sec vs 77 sec •Reduced complication rates by 48% •Reduced re-operations 46% • 1% vs 12% •Reduced average length of stay 27% • 10.6 days vs 14.6 days 23 • Cadaveric Study – New robotic device – Coupled with flat panel CT guidance – 38 cadaver screws • 37 (97.4%) fully contained • 1 screw ,1mm lateral breach 8 12/14/2016 •20 patients , 1 surgeon •10 robot (40 screws) •10 freehand (50 screws) •Operating time •Robot 187 min •Freehand 119 min •Accuracy •Robot •36/40 successfully placed (4 manually placed) •97% accurate •Freehand •50/50 successfully placed •92% accurate First Report from MIS ReFRESH ‐ a Prospective, Comparative Study of Robotic‐ Guidance vs. Freehand Pedicle Screw Placement in Minimally Invasive Lumbar Surgery IMAST 2016 Zahrawi F1, Schroerlucke SR2, Good CR3, Wang MY4 • Prospective, comparative multi-center study – Robot vs Freehand • • • • Lumbar instrumented fusions: 1-3 levels Complications Accuracy Rate of revision surgery • 143 cases • 118 robot, 25 freehand • Fluoro time • 3.2 sec/screw robot • 12.5 sec/screw freehand (p<0.001) • Complications • Robot – no complications • Freehand – 1 neuro deficit, 1 infection (p=0.03) Robotic-Guided Spine Surgery Potential Advantages • Improved Accuracy • Less Intra-op Radiation 140 260 • Complex procedure / anatomy •DOES change my usual technique • MIS • Screw cadence facilitates rod placement • Plan skin incision 9 12/14/2016 Robotic Weaknesses Maximum ~ 5 levels per scan Lack of live intra-op feedback Cost / availability Learning curve Registration issues Robotic Spine Surgery Conclusions • Many robots in development, FDA approval/studies ongoing and growing • First FDA approved robot – 120 systems worldwide, 80 USA – >18,000 cases – >120,000 Implants Time when Robot is most beneficial: Complicated anatomy Severe deformity Congenital anomaly Previous surgery Osteoporosis Morbid Obesity Minimal visualization 10 12/14/2016 Thank You! 11 12/14/2016 Advances in Robotics and Navigation for MIS Spinal Surgery Michael Y. Wang, MD Professor & Spine Director Departments of Neurological Surgery & Rehab Medicine The Miller School of Medicine at the University of Miami Disclosures Consultant: Depuy Spine Aesculap Spine JoiMax K2M Royalties: Children’s Hospital of Los Angeles Depuy Spine Springer Publishing Quality Medical Publishing Stock: Innovative Surgical Devices Spinicity Grants: Department of Defense Disclaimer New does not mean better ! 1 12/14/2016 Surgical Obsolescence The Morbidity of Open Surgery Pain Disability Inciting Event Surgical Intervention Muscle Healing Bony Fusion The “Cost” of Surgery Pain POD #1 Preop “Healthy” Inciting Event Surgical Intervention Muscle Healing Bony Fusion 2 12/14/2016 Disadvantages of Minimally Invasive Spine Surgery › Technically challenging › Inadequate visualization › Disorienting › Difficult to manipulate instruments & structures › ? Iatrogenic neural injury ? High Complication Rates Resulted in a previous generation of spine surgeons being disabused of MIS The “Disconnect” MIS Adoption remains at less than 20% of lumbar fusion surgeries Reasons: • Safety concerns • Lack of familiarity • Limited applications • Increased work effort • Financial disincentive So what is the role of Robotics & Navigation? 3 12/14/2016 Different Surgical Robots Cyberknife® Da Vinci® Who Needs Robotics? • • • • • • Too expensive It will slow me down I’m doing just fine Don’t fix what isn’t broken Just helps place K-wires Marketing ploy “Maybe it’s good for other surgeons, but I don’t need it” 4 12/14/2016 13 Doesn’t technology add to cost? Complication Avoidance 5 12/14/2016 Pedicle Screw Misplacement Problem: The radiographic breach rate is > 5% in open surgeries Solutions: 1. Experience 2. Intra-operative visualization/palpation 3. Proper X-ray guidance 4. Neuronavigation 5. Neuromonitoring Good judgment comes from experience, and experience comes from bad judgment Can MIS Techniques Get You There? 6 12/14/2016 Renaissance 4-Step Workflow Pre-Operative Blueprint Hardware Attachment 3D Synchronization Surgical Execution Planning Software 20 Enabling MIS 140 260 7 12/14/2016 Bed Mount 24 8 12/14/2016 Review of evidence on Renaissance accuracy Year Study type # screws Safe Screws Hu Author 2013 Retrospective 960 98.9% Onen 2014 Prospective 136 98.5% Kim 2015 RCT** 80 100% Fujishiro 2015 Cadaveric study 216 100% Kuo 2016 Retrospective 317 98.7% Weighted average * ** 99.0% Fully within the pedicle or breaching <2mm RCT = Randomized Control Trial MIS ReFRESH 26 MIS ReFRESH • • • • • Prospective Multi-center (currently 6 sites) Controlled, partially randomized study Adult degenerative lumbar disease Fusion surgery of 1 to 3 levels Outcome Measures • Surgical complications • Revision surgeries • Intra-operative fluoroscopy 9 12/14/2016 MIS ReFRESH - Surgical Outcomes • No significant differences in: – – – – Charleson comorbidity Index (0.5) Gender (60% female) Age (58) BMI (30.8) Sites* Robotic Freehand 3 2 P-value Patients 118 25 # levels 1.4 (1-3) 1.1 (1-2) 0.006 Fluoro/screw 3.2±2.8 12.5±7.9 <0.001 Complications 0 2 0.034 Revisions 0 2 0.034 *1 surgeon randomized patients to both arms Retrospective Comparative Analysis Sweeney et al. Robotics MIS vs. Freehand MIS & Open Doctor’s Hospital, Sarasota, FL 268 patients Adults, thoracolumbar degenerative spine disease Parameter Robot MIS # of patients 167 99 vs. robot robot ppvs. 46 vs. robot robot ppvs. 53 vs. robot robot pp vs. % female 48.5 42.4 >0.05 50.0 >0.05 35.8 >0.05 Age 68.3 62.6 <0.001 60.5 0.001 64.6 0.093 BMI 31.4 31.2 >0.05 30.3 >0.05 31.7 >0.05 Screws per case 8.2 7.2 <0.001 5.6 <0.001 8.7 >0.05 % complications 4.8 10.1 >0.05 6.5 >0.05 13.2 0.034 Total Freehand Freehand MIS Freehand Open Case Mix by Surgical Approach Sweeney et al. 60 FH MIS FH Open – Freehand MIS performed mainly in 1 level cases – Single case of 4 levels Freehand MIS • Robotics enables MIS in all types of cases 50 RO MIS 40 30 Number of cases • Clear preference for Freehand MIS in short fusions 20 10 0 1-4 5-6 7-8 9+ Screws Executed 10 12/14/2016 Procedure Time by Technique – Sweeney et al. Skin-to-skin (min) Levels 1 2 3 4+ FH Open FH MIS RO MIS 166 127 120 206 170 134 222 260 153 212 246 185 Freehand MIS Freehand Open Robotic MIS • Robotics MIS is significantly faster than freehand MIS or open Multi-level Robotic MIS case takes about as long as a 2-level freehand case Fluoro Exposure by Technique – Sweeney et al. • Robotics reduces fluoro by: Levels 1 2 3 4+ Fluoro time - seconds FH FH RO Open MIS MIS 126 100 45 123 123 47 227 255 71 180 250 75 Reductions in % vs. vs. open MIS 64% 55% 62% 62% 69% 72% 58% 70% Freehand MIS Freehand Open All results are statistically significant Robotics MIS requires significantly less fluoro than freehand MIS or open Pros • Improved planning • Implant management • Enables surgeons to do complex surgery • Axial rotation & deformity are no longer a challenge • Stepping-stone technology Robotics MIS Cons • Requires one mm CT scan • Capital equipment costs • Learning curve • Attachment to the patient or bed • Dependence on technology • Unrecognized screw misplacement 11 12/14/2016 34 12 12/14/2016 Challenges in this case • Obesity • Level localization (T4) • Surrounding structures (blood vessels, lung, spinal cord, ribs, intercostal nerves) • Access trajectory • Medical co-mobidities Robot Registraiton Access at T4 13 12/14/2016 Endoscopic Debridement A Marriage of Technologies Robotic localization, trajectory, & access + Endoscopic debridement Who likes the robot? 7th year resident 1st year resident (intern) Performed > 500 spine surgeries Performed < 10 spine surgeries From Missouri Worked at Blackrock in NYC Married w/ two dogs Single (but monogamous) IQ ~ 145 IQ ~ 154 14 12/14/2016 Paul Bunyan & Babe vs. New Technology The Future of Medicine Minimally Invasive 15 12/14/2016 Robotic Assisted Spine Surgery (RASS) Use in Deformity Ronald A. Lehman, Jr., MD Professor of Orthopedic Surgery, Tenure Chief, Degenerative, Minimally Invasive and Robotic Spine Surgery Director, Robotic Spine Surgery Complex Pediatric and Adult Scoliosis Service Co-Director, Spine Fellowship Director, Clinical Spine Research Co-Director, Orthopaedic Clinical Research THE SPINE HOSPITAL New York – Presbyterian The Allen Hospital Why Surgical Guidance • Surgical Planning • Create total 3D custom plan for patient • Consider challenging anatomy • Optimize implant size and placement • Accommodate MIS (proximal facet joint, tulip head alignment, rod passage) • Intra-op Guidance • Allows OR staff to be in sync with surgical plan • Streamline implant sizing and sequence to OR staff • Execute surgical plan • Lock trajectory any point, regardless of patient position Robotic Assisted Spine Surgery 1 12/14/2016 How it Works 1. Create Surgical Plan • • • • Upload pre-op CT Position implants with Planning software Assess in all 3 planes Consider global alignment Can also create plan Intra-op with O-arm scan (“Scan and Plan”) Robotic Assisted Spine Surgery CT-based 3D Planning Workstation Robot Unit Registration AP/Oblique 2 12/14/2016 How Does it Work? Registration Step 1: Pre Operative Planning Step 2: Mount Step 3: 3D Sync Step 4: Operate Preoperative blueprint of the ideal surgery is created using CT-based 3D planning 3 12/14/2016 Step 2: Mount Robot Unit Step 2: Mount Step 3: 3D Sync Step 4: Operate Preoperative blueprint of the ideal surgery is created using CT-based 3D planning Step 3: Acquire and Sync Step 2: Mount Step 3: 3D Sync Step 4: Operate Preoperative blueprint of the ideal surgery is created using CT-based 3D planning Step 4: Operate Step 2: Mount S2AI Step 3: 3D Sync Step 4: Operate Preoperative blueprint of the ideal surgery is created using CT-based 3D planning 4 12/14/2016 Potential Advantages • Less radiation – Surgical Team vs. MISS with Flouroscopic Assist – ? Patient (requires preop or intraop CT scan (similar to navigation) • Less exposure – If employed in MISS or MAST Setting • Accuracy = Big Question – Freehand? – Navigation? – Flouro Assist? • Based on “segmentation” vs Navigation (alignment) Work Flow Freehand 1. 2. 3. 4. 5. 6. 7. Exposure Facetectomies Decompression(s) PCOs Screws (benefit open canal) TLIFs Correction Robotic Assistance 1. 2. 3. 4. 5. 6. 7. Exposure Wires/Tap +/- Screws Facetectomies Decompressions PCOs TLIFs Correction Screw Placement 5 12/14/2016 Adult Deformity HISTORY OF PRESENT ILLNESS: 57 yo F with several years of back and leg pain with scoliosis - Low back pain 70% - Leg pain 30%. right hip and right calf pain - Has right calf weakness and numbness - Had an injection 3 months ago, which helped her for a little it. PHYSICAL EXAMINATION: - Right EHL 4/5, gastroc 4/5 - Decreased sensation on the lateral aspect of right leg and right foot IMAGING: - Xray: scoliosis of approximately 50 degrees, fractional concavity on the right hand side. She has overall good sagittal balance. - MRI: disc desiccation most prevalent at L4-L5 and L5-S1. She also has spondylosis and degenerative disc disease as well as facet hypertrophy. PI 6 12/14/2016 L3/4 L4/5 Right Foramen L5/S1 Mid-Sagittal Left Foramen 7 12/14/2016 ASSESSMENT: 57 yo F with degenerative scoliosis and olisthesis, radiculopathy PLAN: OLIF vs TLIF at L5/S1 PSF T10 to ilium Decompression R L4/5 and L5/S1 Robotic Assistance – Left; Freehand on the Right 8 12/14/2016 Three Column Osteotomies (3CO) 9 12/14/2016 10 12/14/2016 Pedicle Subtraction Osteotomy (PSO) 11 12/14/2016 COMPLEX CASES 12 12/14/2016 L4 L3 L5 S1 13 12/14/2016 T12-L1 L1-L2 L3 L2 L4 L5 L5-S1 14 12/14/2016 15 12/14/2016 Current Limitations 1. Work Flow Changes 1. Requires screw preparation first 2. Cannot remove bone 2. Mandates CT scan (pre or intraop) 1. Less radiation for OR Team (vs. flouro) 2. More radiation for patient (vs Freehand or flouro) 3. Time 1. More than Freehand Technique 2. 30 Studies Increased accuracy Decreased radiation Decreased complications • First FDA approved robot – 120 systems worldwide, 80 USA – >18,000 cases – >120,000 Implants • 2 systems currently FDA approved – More to follow 3
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