Other Articles

Biologics for Spine: Where We Are Now
Dr. Jeffrey Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, discusses the exciting happenings in spine biologics, including growth factors, the use of different genes, and injecting stem cells into the disc. And then there are the challenges, namely the disc environment and the funding environment.

Physician Medicare Payments: Grandma vs. Docs
The fight over Medicare physician payments in Congress has been reduced to a fight over limited public dollars between Grandma and her physician. Is this a prelude to how public health care policy will be decided in the future? Read about the tussle here.

Spine Niche! Opportunity in the Spinal Deformity Market
Given the myriad of start-up companies pursuing the same patients, product differentiation and solutions for specific target markets could be the key in the future. Using the PearlDiver Patient Records Database we estimate procedure volumes for posterior fusion as a treatment for scoliosis—followed by the results of a study identifying complications associated with instrumented posterior thoracic fusion in treating scoliosis.

AAOS Political Action Committee
Active players in the orthopedic field know the importance of the AAOS Political Action Committee (PAC). On the cusp of hot topics affecting physicians and patients, the AAOS PAC works diligently to provide data to members of Congress and improve the present and future of orthopedics.

Who ARE These Guys?
Every 60 seconds or so a surgeon tears the cover off an Integra LifeSciences package. Quietly, this company has become the seventh largest medical implant manufacturer serving orthopedic surgeons in the world. Where to now? Would you believe $1 billion in two years? How about $2 billion by 2015?

Redemption in a Mechanism of Failure: The TOPS™ Story
Impliant’s TOPS™ System had a “squeaker” in its clinical study. After a voluntary suspension of the study by the company and finding the mechanism of failure, the FDA has approved a resumption of the study. What insider lessons were learned? Class starts here.

Who is Numero Uno in the PearlDiver Database!! Are You Surprised?
The answer may surprise you. Is it sore backs, aching hips, sore knees, fingers? PearlDiver details 3.8 million spine related complaints—complete with demographic information and charging information. But that’s not #1. PearlDiver also lists 3.5 million large joint complaints. Sorry, still not #1. What could the most common orthopedic complaint possibly be? To get the surprising answer…read on.

What the Knees Need: Baby Boomers and Their Options
Knee patients often show up at the doctor’s office with recurrent mechanical symptoms. It is up to the orthopedist, says Dr. Giles R. Scuderi, Director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, to thoroughly assess the patient and then determine if nonoperative treatment will do, or if the person needs a unicompartmental or total knee procedure.

Physician: Report Thyself
The government says its healthcare anti-fraud efforts are working and it wants to encourage physicians to self-report possible fraud. How well did the government do in 2007 and what about those deferred-prosecution deals with undisclosed evidence? Read about it here.

Revising the Statistics
The word that orthopedic patients least want to hear is “revision.” Who, in the universe of large joint patients, do we expect to see on the receiving end of this news? If you guessed “the elderly” you would have been wrong. The reality of who is hearing “revision” may come as a surprise. Read what we found when probing PearlDiver’s database.

Where Is Ben Now? Trends in Venture Capital
What is being funded by VCs and why? First of all, spine is having to share the spotlight, says Gary Stevenson, Managing Partner at MB Venture Partners, LLC. Here Stevenson outlines what constitutes an attractive investment…he also highlights issues that are affecting the distribution of VC funding.

The Hounds of Wall Street
Conventional wisdom on Wall Street is that ArthroCare is in a bare-knuckle fight to the finish with short sellers. Which leaves us with the dominating question: If ArthroCare is essentially a “lame duck” growth stock, then why are sales, earnings, and the stock price contradicting the short seller’s dire predictions and even outperforming consensus analyst forecasts? We have the answer.

The Era of “Tell Me Right Now” Dawns at FDA
The FDA wants the next phase of post-market oversight to change from self reporting to proactive surveillance. How? Through the Sentinel Initiative. Read what it means to device manufacturers here.

The Day After Tomorrow: Complication Rates and Instrumentation Trends in Posterior Lumbar Fusion
Could PearlDiver be the Nostradamus of spinal instrumentation? This most commonly performed surgery on the lumbar region of the spine increases fusion rates and improves spinal stability—but what about complications? Using PearlDiver’s database we find the answers. Are you ready for some quatrains about what happens next?

You Try It. No You Try It First: New Technology Adoption
What are the forces working for and against new technology adoption? Youth versus age, risk taking versus conservatism, and the economic realities of the day, says Dr. Rick Guyer, President of the Texas Back Institute.

Cheaper, Thinner, Faster, Stronger
In this, the second of our series of three articles on innovation, we tackle the question: How do you measure medical technology innovation? While difficult, measuring innovation is NOT impossible. Why? Well to start, and in the immortal words of Supreme Court Justice Potter Stewart, “We know it when we see it.”

SAS Crosses the Rubicon in Miami Beach
The SAS 8th Annual Global Symposium in Miami Beach may have crossed the Rubicon. How? Read about the Society’s opportunities for growth and collaboration as its new President lays out a vision for the future.

Global positioning system (GPS) technology for cars was a great idea. GPS for surgery is even better—especially if it’s done right. Says Dr. Choll Kim, director of the Spine Fellowship Program at the University of California, San Diego (UCSD), “Image guided surgery [IGS] has been used in brain surgery for quite awhile. The idea of using IGS in spine has been around for about 10 years, but interest in spine did not take off and the machines sat in a corner and gathered dust. Now things are shifting.”

Part of the reason for the initial hesitation was the complexity. “Using an optical camera to look down on the spine, like a car with a GPS system, allows you to move the instruments, navigate around the spine, and know exactly where you are,” says Dr. Kim. “The significant drawback was that a CT scan was needed before surgery. This CT would then need to be loaded onto the computer, and the spine exposed surgically so that the surgeon could point to the spot on the screen that corresponds to the spot on the open spine. All of this adds subjectivity and potential inaccuracies. During surgery there may be bleeding, the anatomy may change with insertion of implants, and the position of the patient on the table may shift, etc. Also, it seemed advantageous to use the technology for our complex surgeries. However, these types of surgeries are encountered infrequently. If you are using IGS only every few months, it is difficult to remember all the small nuances of the system. This meant that you would have to climb the learning curve of the technology over and over again.”

But if a surgeon were to become a regular user of navigation, as with any skill, speed and efficiency increase, thereby leaving more time in the day for things such as reviewing cases with residents or taking an extra minute to comfort an anxious patient. Dr. Choll Kim: “One of the misconceptions about IGS is that it makes everything take longer. When we first began using the technology, yes, it turned a two hour surgery into a three hour surgery. Unfortunately, that has stuck in people’s minds. Once you learn it, however, it’s much more efficient and safer for patients. For example, the workhorse is a TLIF [transforaminal lumbar interbody fusion] procedure. Doing that surgery open takes me three hours using a C-arm and involves one to two minutes of radiation. With navigation, it’s 2 to 2.5 hours and 15 seconds of radiation exposure. And yes, radiation is a concern for many people. With minimally invasive spine surgery becoming increasingly common, we now fully depend on intraoperative fluoroscopy. We don’t know what the low dose, long term risk is as a result of this exposure. Most of the data we get for our tolerance limits is extrapolated from animal studies. To protect ourselves from radiation, we wear lead aprons and thyroid shields, which are incredibly uncomfortable. I have done a cadaver study, to be published in the Spine Journal, along with a retrospective review of my clinical experience, and found that the amount of time I used the fluoroscopy machine is halved when I use navigation. More importantly, the radiation exposure to the surgical team is completely eliminated because the images are taken while we are standing away from the surgical table, behind a lead shield. When I don’t use navigation, I need to remain within the surgical field trying to work around the fluoroscopy machine wearing bulky protective equipment. The C-arm technician must bring the machine in and out intermittently throughout the case, which takes up valuable OR time. The way I use spinal navigation for minimally invasive spine surgery, everything seems easier.”

At the bottom of any solution is hard data. “Looking into the future, there are a number of studies planned to determine the accuracy of advanced imaging technology for different types of MIS techniques. Also helpful will be the new O-arm, an intraoperative CT scanner that can be moved about in the OR to obtain CT quality 3D imaging. I would say that in approximately 10 years all surgeries will incorporate some form of advanced intraoperative imaging combined with robotics. All this should be approached cautiously and scientifically using validated testing methods to ensure safety, efficacy, and effectiveness.”

With an evolving technology, many are likely to sit on the sidelines and wait for everything to be worked out. Others are more curious and leap in. Admits Dr. Kim, “There is a significant learning curve with this technology. As of yet, we haven’t worked out the best way to teach it. We really need surgeons to establish a consensus on how to use it safely and under what conditions. We are currently conducting a series of studies on the learning curve for navigation-assisted minimally invasive spine surgery, which will then be used to design appropriate training labs. I hope that in the future, organizations such as the Society for Minimally Invasive Spine Surgery and other academically-minded groups will get involved in training. As of now, the manufacturers are leading the way in education. The courses tend to be only one day long and unfortunately participants seem to be overloaded and overwhelmed with the technology.”

As of yet, those willing to climb the learning curve are an elite few. “There are only a few surgeons in the U.S. that routinely use IGS for the spine, including Drs. Sasso and Mobasser in Indiana, Dr. Rampersaud in Toronto, Dr. MacMillan in Florida, and the father of spinal navigation, Dr. Kevin Foley at the University of Tennessee. These are the leaders in spinal navigation who are willing to invest the resources in order to learn this extraordinary technology. They will likely be an active part of the solution.”

And when do you absolutely not use navigation? Says Dr. Kim, “There remain a number of simple surgeries, microdiscectomy or laminectomy, for example, that don’t require much imaging. However, we do use the C-arm for even these simple surgeries to localize the level of surgery and to make smaller, more precise incisions. Spinal navigation systems need to become more turn-key to be useful for these types of surgeries.”

Continues Dr. Kim, “At first glance, it seems logical that IGS would be most useful in cases where there is an unusual or complex anatomy. However, most surgeries we perform don’t involve odd anatomy. We need to start thinking about using this technology in things we do every day and need to take into account what happens in real life surgeries. For instance, we now do a lot of surgeries where we change the alignment of the spine. Something as simple as a spondy reduction will throw off the preoperative CT and can lead you astray. There are simple solutions to these problems, but they are all relatively new. The technology I use for MIS eliminates these problems because it does not depend on preoperative imaging. Everything is in real time. If the anatomy changes during surgery, I take a new set of pictures using the Stealth Navigation C-arm. This is simple, rapid, and ensures anatomic accuracy.”

Sounding a hopeful note, Dr. Kim states, “The technology has improved dramatically in the last one to two years and now addresses many of the drawbacks. The key improvements have been to simplify the set-up of the machine so that various registration tasks have been eliminated. My preferred system uses no pre-operative imaging, no fiducial registration, and no imaging merging. This has greatly decreased the set-up time, which is now about five minutes. Nowadays navigation has a totally different look and approach. It is a lot more like using the C-arm, but without the lead gear and the machine jutting into the surgical field. I can see that interest in IGS is being stirred. Two years ago when I attended the North American Spine Society meeting, navigation was displayed in a small booth way off in the corner with only one person at the booth. As I walked by, it hit me like a ton of bricks ... the more I need the C-arm, the more I need navigation. As I began talking to other surgeons about minimally invasive spine surgery, it became apparent that radiation exposure is a major concern. I expect that as our reliance on the C-arm increases, interest in spinal navigation will increase concomitantly. We have a long way to go to assess the efficacy and enhance the education regarding this technology. I did see a lot more interest at last year’s meeting, however, and am curious about the next couple of years.”

Things in the orthopedic field are often cut and dry. Image guided surgery is not quite there yet. It will have to take the determined, rigorous path that all new technologies must follow in order to become part of the orthopedist’s daily toolbox.