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Procedure of the Month

This is the case of a 68 year-old male suffering from severe back pain for 3 months. Patient failed conservative treatment with high doses of analgesics. MRI was performed, as shown in Figure 1 below. This T2-weighted image clearly revealed evidence of acute fracture with bone marrow edema at the L1 level. Which choice do you think best describes the patient's treatment options (click on the x-ray below to take the multiple choice/guess test)?

Figure 1: Preoperative T2-weighted sagittal MRI showed evidence of bone marrow edema indicative of acute fracture at the L1 level (arrow).

Case review and x-rays courtesy of
Dr. Bassem A Georgy.
Interventional Radiologist Valley Radiology Consultants Assistant Clinical Professor University of California, San Diego

SPONSORED BY:


Procedure of the Month Sponsored by DePuy Spine, Inc.


 

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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.

INBONE™ Launches New Fusion Clinical Study
By Elizabeth Hofheinz, MEd, MPH
December 6, 2007

In conclusion, it’s faster fusion (OK, the results are still early). INBONE Technologies has announced that early results are showing that the INBONE™ Fusion System can accelerate the fusion rate to an average 4- to 8-week timeframe, with non-union rates at a very low 2%. That fusion time is approximately twice as fast as fusion using traditional plates and screws and approximately one-tenth of the failure rate of traditional methods.

Nine U.S. surgeons from both private and university hospitals have agreed to participate in a new expanded clinical study for the INBONE Fusion System. The surgeons, from such institutions as Duke, UCLA, and Yale, will be working with a System that received 510(k) clearance from the FDA in July 2005. Since then over 100 fusion cases have been completed using the System. The current study is intended to expand the clinical data on the accelerated fusion rates as well as show a decrease in non-unions for the INBONE System vs. traditional plates and screws.

Commenting in the news release was Dr. Mark Reiley, the inventor of the System and INBONE’s Chief Medical Officer: “I am humbled by the quality and quantity of surgeons that are participating in this study. It is encouraging to know that surgeons believe that this new technology may well improve patient outcomes significantly.”

As indicated by the company, the INBONE Fusion System offers an intramedullary approach to small bone fusion and consists of titanium rods and plates which are surgically implanted within the bone to yield unparalleled three-dimensional fixation. The porous plasma spray coating conducts bony in-growth across the implant and joint.

Via email Dr. Reiley noted, “Having just reviewed my first 47 INBONE Fusion rod patients with follow-ups greater than one year, I discovered a number of interesting findings. Specifically, we saw 4-week fusion times for the Great MTP Joint, 7- to 8-week fusion times for the Tarso-metatarsal joints, 8-week times for Triple Arthrodeses, 8 weeks for isolated subtalar fusions, 8 weeks for subtalar fusions associated with Total Ankle Replacement, and 10-week fusion times for extended fusions, e.g., Talo-Naviculo-Cuneiform Fusions. All in all, these findings mean a much shorter period of time requiring cast immobilization for any type of joint fusion in the foot.”

 

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