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Robotics?in
Spine Surgery?
Jae Y Lim, MD
Reston, VAApril 29, 2015
My Background
BA/BS Stanford University
MD Yale University
Neurosurgery residency UCLA University Hospitals
Fellowship complex spine Cedar Sinai Medical Center
Atlantic Brain and SpineClinical Adjunct Professor
NeurosurgeryVCU Medical School
Northern Virginia Campus
Future or Present?
Goals
Provide useful information that you can use to advise and counsel your patients regarding spine surgery
Overview
Current state of spine surgery in America
Does Laser spine surgery exist?
Robotics How can we do better
Caveman brain surgery
Spine Surgery
Now?
Molecular or Bionics?
Spinal fusion in the United States: analysis of trends from 1998 to 2008.Rajaee SS1, Bae HW, Kanim LE,
Delamarter RB.Spine, Jan 2012
Between 1998 and 2008, the annual number of spinal fusion discharges increased 2.4-fold from 174,223 to 413,171.
During the same time period, laminectomy, hip replacement, knee arthroplasty yielded relative increases of only 11.3%, 49.1%, 126.8% in discharges
Spinal fusion in the United States: analysis of trends from 1998 to 2008.Rajaee SS1, Bae HW, Kanim LE,
Delamarter RB.Spine, Jan 2012
Between 1998 and 2008, mean age for spinal fusion increased from 48.8 to 54.2 years
National bill for spinal fusion increased 7.9-fold (P < 0.001).
12.8 billion dollars for spinal fusions in 2011
End Results of 2 decades of spinal fusions
Hundreds of thousands of patients helped by advanced spinal fusion techniques
But at increasingly unacceptable burden to the economy
Too much collateral damage in terms of failed fusion patients
What about the Next 10 years?
Affordable Care Act – aka Obama Care will remove incentive for surgeries
Patients increasingly have higher expectations for outcome and higher reluctance to have fusions
What about the Next 10 years?
Transition to quality of care not quantity
Fewer spine fusions but need to do it better
Why are patients increasingly rejecting spinal fusions?
Horror stories from hundreds of thousands of failed fusion patients
Intuitive rejection of “caveman approach”
Desire to embrace technology
Laser spine surgeryWhy do patients ask for this?
Laser is catch all phrase for high tech
MIS Surgical Navigation
Systems Intraoperative CT or MRI
scanners Preoperative CT/MRI
registered intraop Robotics
Laser spine surgery Myth
Laser is a more elegant and precise tool compared to drills, scalpels and cauteries that are currently used
It’s noninvasive, bloodless
Myth is propagated by unscrupulous laser spine centers
Laser spine surgeryFacts
Laser spine surgery does involve incision
Laser plays a minor role in procedures
Laser can only be used in minority of patients in subset of cases
Very few published studies
Percutaneous laser disc decompression versus conventional microdiscectomy in
sciatica: a randomized controlledSpine, Jan 2015
115 Patients in the Netherlands
At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery.
Higher speed of recovery in favor of conventional surgery
Reoperations were significantly less in the conventional surgery group
Laser spine surgeryFacts
Most procedures offered and performed at these centers are standard surgeries
Laser spine centersFacts(Bloomberg Business)
15 malpractice lawsuits since October 2009, a period in which the company performed about 7,500 procedures
Nationally, outpatient surgery centers received about six malpractice claims for every 20,000 surgeries,
6.7X the rate of law suits
Crossroad in Spine Surgery
Crossroad in Spine Surgery
Prove efficacy
Control cost
Minimize complications
Laser spine surgeryWhy do patients ask for this?
Laser is catch all phrase for high tech
MIS Surgical Navigation
Systems Intraoperative CT or MRI
scanners Preoperative CT/MRI
registered intraop Robotics
Robotics + MIS
Combine with MIS approaches Interbody fusionsScrew placement
26
MIS Advantages• Potential advantages
compared with “open” surgery– Smaller incisions – Minimize scarring– Less blood loss during surgery– Shorter hospital stay– Less postoperative pain– Less need for narcotics– Faster return to work and daily
activities
• Posterior approach - TLIF• Anterior/Lateral approach -
XLIF
Literature Comparison of multifidus muscle atrophy
and trunk extension muscle strength: percutaneous versus open pedicle screw fixation
Kim DY, Lee SH, Chung SK, and Lee HY, Spine 2005
Prospective study of MIS vs open screws on: Multifidus muscle cross-sectional area Trunk extension muscle strength
Sig decrease in the XS muscle area of open group
MIS group demonstrated positive effects on postoperative trunk muscle performance
Preop Postop
MIS
Open
Problem with MIS
MIS procedures require much longer periods of radiation exposure for both OR staff and patients
Steep learning curve for surgeons
Why Robotics?
Preoperative planning reduces need for intraop xrays
Eliminates the error of the human hand
Easy learning curve for surgeons
For Surgeons
Less radiation exposure in OR
No need to wear lead Wearing a 15-pound lead
apron can place pressures of up to 300 pounds per square inch of intravertebral disks
Less time in OR
-Increased cancer risk for spine surgeons3
Occupational Risk
3. Singer, Occupational radiation exposure to the surgeon, Am Acad Ortho Surg. 2005;13:69-76.
4. Mastrangelo G, et al,. Increased cancer risk among surgeons in an orthopaedic hospital. Occup Med. 2005;55(6):498-500.
-Higher cancer incidence in orthopedic surgeons vs non-radiation exposed matched controls
For Patients
Increased Safety
34www.MazorRobotics.com
1. Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine. 2007;32(3):E111-20.
2. 2. Gertzbein SB, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine. 1990;15(1): 11-4.
Human Factor
- 10% misplaced screws1
- 0.8%-2% permanent nerve damage2
Accuracy in Cadavers
Neurosurgery. 2007 Feb;60(2 Suppl)
29 of 32 K-wires were placed with less than 1.5 mm of deviation
average deviation was 0.87 +/ - 0.63 mm (range, 0-1.7 mm) from the preoperative plan in this group.
Accuracy in Patients
Spine (Phila Pa 1976). 2009 Feb 15;34(4):392-8.
In axial plane, 91.7% of the screws exactly in pedicle, 6.8% <2mm off
In longitudinal plane, 81.2% of the screws exact, 9.8% <2mm off, 1 screw 2-4mm off
Mazor Robotics Technology: Clinical Evidence
37
Revision and deformity
960 implants98.9% Accuracy
2012
Prospective RCT, MIS99% Accuracy
2012
14 medical centers3,271 implants (half
MIS)98.3% Accuracy
2010
Improved implant accuracy by 70%
Reduced X-ray dosage by 56%
Reduced complication rates by 48%
Reduced re-operations 46%
Reduced average length of stay 27%
2011
Is Robot Assisted Screws Worth the Trouble?
Greater accuracy = Fewer complications
Less RADIATION = Safer
Shorter OR time = Faster
39
How It Works
39
Step 1:Preoperative Plan
Step 4:Operate
Step 2:Mount
Step 3:3D Sync
Preoperative blueprint of the ideal surgeryis created in a virtual 3D environment.
SurgeonsReduction in use of fluoroscopy
L4-S1 TLIF2cm lateral incisions3cm midline incision
L4-S1 PLIF 6 cm midline incision
Future applicationSI Joint Pain
Sacroiliac joints are causative for 13-30% of cases with low back pain
SI Joint PainUnder-diagnosed and Under-treated
SI Joint AnatomyCannulated implants Plus Robotic guidance
So Simple Even a caveman can do
this
Mazor OverviewWorldwide 76 systems
• 44 systems in the US• 15 systems in Europe• 11 systems in Asia• 6 systems in the Middle East
• 55,000 implants in 7,500
patients
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