Robotics. Neil Badlani MD, MBA The Orthopedic Sports Clinic Nobilis Health Corp. Houston, TX. The Orthopedic Sports Clinic

Transcription

1 Robotics Neil Badlani MD, MBA The Orthopedic Sports Clinic Nobilis Health Corp. Houston, TX The Orthopedic Sports Clinic

2 Disclosure Consulting/Speaking Medtronic Amendia Nutech Mazor * MIS Device

3 Outline Background/Applications Advantages/Disadvantages Robotic technique Clinical evidence Cases

4 3 years 100+ cases Initial Motivation My Experience Less radiation Optimize comfort with anatomy and screw placement Started with larger cases and open cases Now I use it for every instrumented case

5 The Robot fits naturally into MISS Surgical methods devised to achieve objectives of traditional surgery with minimized damage to peripheral tissues.

6 Mazor Robotics Renaissance Only FDA-approved robotic guidance system for spinal surgery Tens of thousands of screws placed Available about 55 sites in the US, 95 internationally The next step in the evolution of spine surgery

7 Computer Navigation- Intraop Robot CT-based 3D planning Guided instrumentation 1 mm accuracy System components: CT-based 3D Planning Software Workstation RBT Unit 7

8 Renaissance Applications Spine Surgery Posterior Surgical Approaches: Thoracic, Lumbar, Sacrum: Open MIS Percutaneous Spinal Fixation Pedicle screws Transfacet, translaminarfacet screws Sacroiliac screws SI fusion Spinal Deformities Scoliosis PSF, osteotomies Cement Augmentations Kyphoplasty and vertebroplasty Oncological Applications Revisions Biopsies, Tumor resections

9 Advantages Surgeon Less Radiation!! (34s vs 77s per screw) Increased confidence, improved accuracy Decreased time per screw Marketing Patient/Clinical Increased precision, accuracy, safety Some studies show 10% misplaced screws, 1-2% nerve injury Hospital Increased volume, marketing References 1. Kantelhardt et al. Eur Spine J Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine. 2007;32(3):E Gertzbein SB, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine. 1990;15(1): 11-4.

10 Radiation Risks Ortho Hospital in Italy, Ortho 29% incidence Ortho Surgeons 5x increased cancer risk In Vitro study Open bilateral ped screws T11-S1 on 6 cadavers X greater than non-spinal MIS procedures References 1. Singer, Occupational radiation exposure to the surgeon, Am Acad Ortho Surg. 2005;13: Mastrangelo G, Fedeli U, Fadda E, Giovanazzi A, Scoizzato L, Saia B. Increased cancer risk among surgeons in an orthopaedic hospital. Occup Med. 2005;55(6):

11 Disadvantages Surgeon Learning Curve- Minimal First 30 cases-> more conversion to manual but equal accuracy Setup Time- Minimal Patient/Clinical Difficult to prove true clinical benefit Hospital COST!- Capital cost 750K No increase in revenue per case References 1. Hu, Lieberman CORR 2013

12 How it works: step 1 Step 1: Preoperative Plan Step 2: Mount Step 3: 3D Sync Step 4: Operate A CT using the Mazor protocol is obtained pre-op. Plan screw placement to fit anatomy

13 Pre-op planning Time spent and the exercise is beneficial for every case Increases understanding of variability in anatomy Notice asymptomatic misplaced screws in revisions Intra-Operative plan differs between open, MIS, revisions.

14 How it works: step 2 Step 1: Preoperative plan Step 2: Mount Step 3: 3D Sync Step 4: Operate Multiple mounting options fit your intraoperative needs. 16

15 Mounting PSIS and spinous process pins placed Robot bridge attached to pins

16 Mounting PSIS and spinous process pins placed

17 Mounting Robot bridge attached to pins

18 HOW IT WORKS STEP 3 Step 1: Preoperative plan Step 2: Mount Step 3: 3D Sync Step 4: Operate -Two fluoroscopy images taken intraop -Synchronized with the CT-based surgical blueprint (independent of anatomy). -Registers each vertebral body independently for unparalleled accuracy

19 Registration AP and Oblique xrays taken with registration markers

20 Registration AP and Oblique xrays taken with registration markers

21 How it works: step 4 Step 1: Preoperative plan Step 2: Mount Step 3: 3D Sync Step 4: Operate 23 23

22 Operate

23 Operate

24 Operate

25 Clinical Evidence Mazor Robotics 98.3% Accuracy of 3,271 implants in 635 cases in 14 medical centers with 49% of implants placed percutaneously (typically 10%-20% of spine surgeries are MIS) Devito DP, Kaplan L, Dietl R, et al. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine J. 2010;35(24):

26 Clinical Evidence Mazor Robotics Compared to freehand surgery, in 112 cases Mazor Robotics-guided surgery significantly: Screw Accuracy 94.5% Mazor vs 91.4% Conventional (p<0.05) Reduced X-ray dosage by 56% Reduced complication rates and LOS OR time equivalent Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011;20(6):

27 Clinical Evidence Mazor Robotics 99.7% Clinical Acceptance of 1,815 implants in 120 scoliotic adolescents Devito DP, Gaskill T, Erikson M, Fernandez M. Robotic based guidance for pedicle screw instrumentation of the scoliotic spine. Presented at Pediatric Society of North America (POSNA); May 2011; Montreal, Canada.

28 Clinical Evidence Mazor Robotics 98.9% successful and accurate screw placement in 960 screws in 95 patients (deformity and revision surgeries) Hu, X, Ohnmeiss D. Lieberman,I. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J ( :

29 Cases L4-S1 open posterior with high grade spondylolisthesis

30 Cases L5-S1 percutaneous posterior after ALIF

31 Cases Multi-level percutaneous instrumentation after LLIF

32 Why Robotic Spinal Surgery? Less radiation Safety is improved Better outcomes with MIS Allows safer treatment of complex deformity No additional cost to the patient

33 Thank You