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

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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

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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

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How It Works

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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