Other Articles

Oxiplex® – “Not Approvable”
The FDA’s Orthopaedic and Rehabilitation Devices Advisory Panel said FzioMed’s Oxiplex gel was safe but not proven to be effective, and therefore, not approvable. Did statistics get in the way of something that’s needed, works for some and is safe? Decide for yourself.

Tiger’s Knee and the Cruel Twist to the Sport of Golf
At the U.S. Open in June, Tiger Woods played through intense knee pain to stay on the leader board. His next appointment is with an orthopedic surgeon. Last year there were 103,000 golfing related orthopedic injuries reported. That’s $2.4 billion in medical care. For more on this important and growing market segment read on.

Carpal Tunnel Syndrome: The Causal Controversy
An issue important to big business, the little guy, and insurers alike, the cause of carpal tunnel syndrome (CTS) is a hot potato. According to two orthopedic surgeons familiar with the issue, CTS is largely idiopathic. Here we examine the medical, sociological, biopsychosocial, and behavioral issues related to the problem.

Transitioning to Post-Graduate Year Two: Residents Speak
Going from PGY1 to PGY2 is like going from being robotic to being a decision maker. So say two PGY2 residents, whose experiences transitioning to their second year are telling and instructive for those designing curricula.

Chiropractic: When BS Becomes Rx
Increasingly, spine centers are incorporating chiropractic services as part of their “one-stop-shop” market positioning. This is an interesting issue for surgeons—particularly if the surgeons have a financial interest in the center. Should $30 billion BS become Rx? Maybe.

Off-Label BMP Warning Fallout
FDA’s warning last week about off-label use of rhBMP products should be fair warning to companies developing a new biologic product to be prepared to go through the regulatory ringer. What happened and what’s next? Read on.

Tissue Engineering: The View From Cincinnati
David Butler, Ph.D., a Professor of Biomedical Engineering at the University of Cincinnati, is working to shift the field of tissue engineering. He and his colleagues have set out to determine how much force a given tissue experiences and what the patterns of those forces are. The answers would then provide information for designing new products. And they’re up to much more….

Breaking the Rules to Success
On January 10, 1994, Kyphon became a corporation. That was a defining moment in corporate medical history—not because the company would sell 13 years later for $3.9 billion—but because Kyphon would eventually break almost every rule of medical technology company success. Kyphon was, we now realize, an All-American rebel and its influence is spreading to Medtronic and other companies.

U.S. Senate Fails to Stop Physician Pay Cuts; CMS Stops Processing All Claims
Congress goes on recess leaving physicians with a 10.6% pay cut from Medicare. In response, CMS halts all claims processing for two weeks. Congressional Physician’s Caucus Founder Phil Gingrey, M.D., tells us what happened and what will come next. Read here.

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.

Most of us want to avoid fat cells. But Dr. Francis Shen goes looking for them. More on that later.

Dr. Shen, assistant professor in the Division of Spine Surgery at the University of Virginia Health System, was born in Ann Arbor, Michigan, while his father was getting a graduate degree in engineering. Dr. Shen’s mother stayed at home at the time, but later she would return to school to receive her degree in mathematics and computer science. “We then moved to Maryland,” says Dr. Shen, “where I developed a propensity for the sciences and my older brother would begin his career path in law. I was pretty enthralled with engineering and always enjoyed the way it makes one move through problem solving in a systematic fashion. I couldn’t have selected a better undergraduate degree for my personality.”

He came to find out, however, that the intangibles also held sway for him. “While pursuing my undergraduate degree in biomedical engineering at the University of Michigan, I volunteered in a hospital and interacted with a host of people whose roles were totally new to me—doctors, nurses, and patients, among others. I was struck by how grateful the patients were, even for something as simple as a conversation with a transporter or a volunteer. I could see they were looking for someone to be there with them, and for someone to listen and talk to. And I was frequently in the operating room as part of one of my undergraduate classes in biomedical engineering. The objective part of medicine held an allure for me, i.e., going to the OR and observing the process. Then there was the subjective side of things where I volunteered on the wards and spent time with patients. While in the operating room I studied flow patterns of the surgeons and staff, and I examined the turnaround times between cases―essentially, what was the throughput and how and why it occurs. I realized that medicine was pretty incredible and thought my biomedical degree would dovetail nicely with a medical degree.”

From the long-term adventure of taking care of children to the concreteness of orthopedics, Dr. Shen has allowed himself to explore his interests. Systematically, of course. “When I began medical school here at the University of Virginia (UVA) in 1992 I was initially interested in pediatrics. My own pediatrician was someone for whom I had a great respect, so I went to talk with him and early on during medical school ended up shadowing him in his practice. I liked how you could have well child visits and not just see patients with major medical problems. It was also heartening to know that you would be following these patients longitudinally and really get to know them and their families. In my second year of medical school I got involved with basic science research in a neurosurgery lab investigating brain imaging. After that experience, being back in the OR was completely different. I was then able to see the procedural component of medicine that I wanted, meaning that I could do something and there would be a definite outcome. I think there is also something deeply personal about surgery between a surgeon and his patient that is like nothing else in medicine. Also, about that time I began rounding with several orthopedic surgeons and got into the OR with them on total joint replacements. Something clicked and I knew I would be heading into a career in orthopedics. It was something about orthopedics. A patient comes in with a dislocated wrist; you set it, look at the X-rays, and can see you are having an immediate effect. Also, from an engineering standpoint there are a lot of biomechanical concepts involved, more so than in other specialties. That was very appealing.”

And while Dr. Shen might be involved in clinical trials, there is nothing random about his approach. “In 1996 I began my orthopedic residency at UVA. Thinking through my career goals I could see that the wisest move would be for me to do the six-year program, with five years of residency and one year of basic science research. It was one of the best decisions I ever made. The effects of that research year have never ended in that it helped me take the things my mentors gave me and understand how to proceed with the scientific process. It was in this extra year that I really began to see that research is not random and that when you develop an experimental design you must fully understand the scope of the problem, the interventions, and how to design an experiment in order to identify what the outcomes of the interventions are. You are essentially framing it and isolating what it is you want to investigate. On the basic science end I learned to isolate each factor rather than having confounding variables.”

Moving fully into the clinical arena for a year, in 2002 Dr. Shen began an adult and pediatric spine fellowship at Rush University Medical Center and Shriners Hospitals for Children in Chicago. “I learned from some of the best at Rush. Dr. Howard An: Sometimes I wished I could hear him think as he was working out a clinical problem. He is one of the clearest and most versatile thinkers in the spine world. I model a lot of my practice on him and his philosophy of being as up to date as possible on the orthopedic universe. He was emphatic in his outlook that research and clinical care do not occur in a vacuum so one must be comprehensive. Also important to my professional development was Dr. Ron DeWald, who helped me understand the process of clinical care and surgery. Particularly helpful was his guidance on how you proceed when a case is committed and when it’s not committed. At a certain point in a surgery you are committed in that you must go forward. For example, in spine that can happen as soon as you start the osteotomies. Prior to that, if the patient becomes medically unstable you can close up and return another day and you haven’t harmed the patient (meaning that you have options). However, once you’ve made your osteotomies, you are committed and must complete the subsequent parts of the surgery, i.e., instrument and stabilize the spine. Otherwise, if you had to close up now [after the osteotomies], you would leave the patient with a completely unstable spine. Lastly, I would like to credit Dr. John Lubicky of Shriners Hospital in Chicago. It was a great experience to witness this comprehensive and caring pediatric orthopedist and spine surgeon. I think it’s amazing how he takes care of his patients for their entire lives.”

Virginia may be for lovers…but it’s also for thinkers. On staff at UVA since 2003, Dr. Shen’s star has only risen. He has been awarded significant funding, with one particularly large grant from the Orthopaedic Research and Education Foundation (OREF). Dr. Shen: “What a huge honor it was to receive the Clinician Scientist Award from the OREF. I really never understood how important it was until I got it. This funding allowed me to not just do basic science research but to actually dedicate blocks of time to it, look at all aspects of a problem, and figure out ways to apply solutions to the clinical practice arena. I have utilized this grant to pursue tissue engineering research whereby I try to create bone from tissue that isn’t bone. Using adipose stem cells (fat cells) we have the potential to differentiate them into several cell lineages such as bone, muscle, tendons, ligaments, and nerves. We are treating the cells with GDF5 (growth differentiation factor) and then placing them on a resorbable scaffold. Amazingly, the tissue engineered scaffold looks like bone and produces a mineralized matrix. The differentiated cells can adhere to the scaffold and migrate into it and turn into bone. The results are promising. We are able to do this reproducibly in a test tube and in situ. The challenge has been to place them in an in vivo animal model. While it has been successful on occasion, it’s not reproducible. At present we are using a rat model and having some success in a posterolateral fusion. It works well in the back around the transverse processes, and in the vertebral body up front, but within the muscle pouches it is not as successful. We are still trying to determine why.”

Continues Dr. Shen, “On the clinical research side my goal is to take my tissue engineering findings and apply them. One of the most significant clinical interests in the spine community now is minimally invasive technology. In my practice we do a lot of large spinal reconstructions, so I understand the limitations involved in these. There is a lot of morbidity. On the flip side, I perform a lot of cutting-edge minimally invasive spine surgery as well. My goal is to take these techniques and combine them with my research interests―to percutaneously deliver the cells under image guidance and have them turn into bone or disc so as to eliminate the problems with fusion. There will come a time when we can improve much of what we do through less invasive techniques. If somebody breaks a femur we will be able to stabilize it with resorbable scaffolding and deliver the cells that turn into bone, thus preventing a large open surgery.”

Time plus diligence equals progress. And it doesn’t hurt to borrow from others. Commenting on the future of orthopedics, Dr. Shen notes, “Orthopedics and spine are really coming into a dynamic area because we are now able to do things that we only imagined a few years ago. There is a lot of technology coming from the computer science and imaging worlds that is able to help move our field forward. For example, robotic, virtual imaging, and automated processes already being used in industry can be applied in innovative ways in medicine. Being a mechanical specialty, orthopedics also will continue to benefit from the talents of those who work with metals. Success no longer means individual surgeons in their practices. It’s now the ability to flow real-time information between surgeons and researchers, industry, nurses, and others. Multi-institutional and international collaborations are more and more common and will continue to fertilize orthopedics from other fields.”

When not cutting in the OR, Dr. Shen is cutting across the ice. “My 3-year-old daughter is enamored of ice skating. Seeing as she has her dad wrapped around her little finger, guess where I spend many of my Saturdays?”

Dr. Shen: “I will give my patients the final word. I congratulate them on their courage and good humor in the face of what is often debilitating pain.”

Dr. Francis Shen…balancing the rigor of the lab with an empathic bedside manner.