Other Articles

Multicenter Clinical Trials: Do They Get the Respect They Deserve?
They’re not fast or sexy, but they are critical…large trials, that is. With multiple sites and principal investigators who donate their time, large trials are more complex—and normally yield more actionable data—than smaller, quicker studies. But large trials don’t always get the respect they deserve. And, says at least one physician-researcher, this could affect the future of the field.

Patent Wars: Medtronic Attacks NuVasive
MSD’s lawsuit came amid a period of declining spinal implant market share – from a peak of 60% in late 1998 (just prior to being acquired by Medtronic) to, we estimate, 36% currently – and a growing sense that MSD’s reign as the king of spine was coming to a close. What’s really behind Medtronic’s attack on its former senior exec? Read on.

Spine Gainsharing Through the Looking Glass
The feds have issued their first opinion allowing a spine gainsharing proposal. In Alice in Wonderland style, Through-the-Looking-Glass logic, they said the proposal was improper but would not impose sanctions. Who is the author of such a plan and what’s her secret? Read here.

PearlDiver Data Raises New Questions About Synovial Injections
Synovial injections for painful knees have been approved for use since 1997. If the goal is to improve the quality of life for the patient, is that being accomplished? The latest numbers from the PearlDiver Patient Records Database cast doubt.

Plantar Fascia: The Annual 3 Million Patient Market
“Plantar Fascial Fibromatosis (ICD-9-D-728.71) is right up there in frequency with pain in the shoulder joint, degeneration of lumbar intervertebral discs, pain in the lower leg joint, and carpal tunnel syndrome. As usual, PearlDiver has this market mapped out.

Orthopedic Incubators: Where Little Ideas Grow Up
Business incubation, also known as acceleration, can be a wild ride. Thus it’s best to approach it armed with the solid advice of experienced professionals. Who should take this ride? What can venture financiers bring to the table? These questions and more are answered by two seasoned VC professionals.

Just Say No to CMS Potential Coverage Decision List
Unless you want to be on the receiving end of a non-coverage letter, just say no to CMS’ proposed list of potential National Coverage Decisions. You’ve got until September 28 to make your case. Read what a leading industry consultant and analyst have to say.

Staking a BIG Claim
Alphatec, the company whose IPO collapse served as an object lesson for all medical device companies, has nearly completed its turnaround. The key? New management and new technology. Exhibit A: OsseoFix™—with it Alphatec stakes a claim to the next big spinal implant market.

The Pennsylvania Orthopaedic Society
The Pennsylvania Orthopaedic Society, 1,000 members strong, tackles a variety of challenges on behalf of patients and surgeons alike. According to AAOS, they were the top state professional society in 2007. Fifty-two years in the making, here is how they did it.

Percutaneous Spine Procedures: Just Setting the Stage for Fusion?
Selective nerve root blocks, laminectomies, and percutaneous discectomies. How many times do these procedures lead to a full blown spine fusion? Using PearlDiver’s Patient Records Database, we longitudinally tracked patients to find out. All we can say is that after surveying the 3.9 million spine patients in the PearlDiver database, the answer may be different from what you’d expect!

Physicians Targeted by Whistleblowers
The whistleblowers that targeted Medtronic in 2006 are now aiming their guns on 136 physicians and distributors as we move into the next era of the “Great Disruption.” Read about their qui tam lawsuit in Boston and what it means for industry and surgeons.

Zimmer’s Bet on Compliance
Is Zimmer’s Enhanced Compliance Program going to cost it market share? Analysts demanded answers from CEO Dave Dvorak during the quarterly conference call on July 23 that also included the announcement of the Durom® cup suspension. Dig in here.

Faculty Compensation in Academic Medicine
Dr. Sanford Emery, Chair of Orthopaedics at West Virginia University, has put his M.B.A. to good use. Delving into the issue of compensation in academic medicine, Dr. Emery and his colleagues surveyed 31 orthopedic programs and conducted in-depth interviews with leaders of eight programs. Their findings include information on the compensation structure and point systems.

Engineering an Unfair Advantage
After $1.2 billion in equity capital, what did the tissue engineering pioneers accomplish between 1990 and 2000? For one thing, LifeCell, Integra and Osiris. For another, a generation of wiser, tougher managers who are targeting the big orthopedic markets. Now all they ask for is an unfair advantage. Are the big guys ready?

The Pain of Fashion! 4 Million Patients Every Year and Growing
Eighty-eight percent of all women wear shoes that are too small. Fifty-five percent developed bunions. Despite costs that can reach as high as $20,000 per procedure, four million patients every year seek surgical relief. Want to know the footprint of this market? Read on.

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.

He is known for knees. A director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, Dr. Giles Scuderi is fascinated with femurs and passionate about patellas. Years before acquiring his extensive knowledge of cartilage and bone, however, he was just another boy in Queens trying to find his path.

Says Dr. Scuderi, “I was very close to my uncle, who was a gynecologist. He could see that I was enamored of science and when I began considering premed in high school, he encouraged me to work hard towards that goal. My dad was a banker and my mom was a schoolteacher. You can guess how much she pushed education.”

Displaying a talent for all things cellular, Gil Scuderi graduated premed from St. John’s University in Jamaica, New York. Then it was on to medical school at State University of New York Downstate Medical Center. “I traveled through medical school with a terrific set of classmates, many of whom joined me on the rugby field. Perhaps in playing rugby I was doing some sort of orthopedic experiment, but fortunately I suffered few injuries. During clinical rotations I felt drawn to surgery and to orthopedics in particular. Several things coalesced to make this the right field for me: I’m a hands-on type of person, I find anatomy fascinating, and my grandfather was a contractor, so I had a natural penchant for tools.”

After completing medical school in 1982, Dr. Scuderi entered a residency program at Lenox Hill Hospital in New York. “Dr. Norman Scott, who is now my partner, was one of my mentors during this time. I learned a lot both from doing research with him and from watching him do training evaluations for the New York Nicks and Rangers. Norm could see my future was in knees and eventually guided me toward a fellowship with the incredible Dr. John Insall. Also vital to my residency training was Dr. Barton Nisonson, someone who taught me many of the sports medicine techniques I use today. Along with Dr. Nisonson, Dr. Jim Nicholas gave me the opportunity during residency to learn sports medicine and work with the New York Jets. Treating professional athletes taught me the importance of training and preparation for athletic competition, as well as the wide variety of injuries seen within athletics. It also gave me a significant appreciation for the sometimes-harried conditions in which team physicians must work. I recall a Monday night game between Miami and the Jets where I was sewing up a player with a scalp injury when in comes a player with a dislocated elbow, and a minute later someone with a bad ankle. I came to realize the importance of teaching them to prevent injuries.”

Taking Dr. Scott’s advice, Dr. Scuderi applied for and secured a fellowship at the Hospital for Special Surgery (HSS) with the renowned Dr. John Insall. “My fellowship in knee surgery, which began in 1987, was even more than I expected,” says Dr. Scuderi. “I developed a great relationship with Dr. Insall, who taught me ligament reconstruction, how to handle patella problems, as well as joint replacement and revision. I eventually became his partner, and went on to publish articles with him on total knee replacement, surgical techniques, as well as the first article on survivorship of total knee replacements.”

Continues Dr. Scuderi, “I spent the first five years after my fellowship in a general practice on Long Island. I focused on knee surgery, was on staff at two community hospitals as well as HSS, and maintained a relationship with Dr. Insall. In 1991 the Insall, Scott & Kelly Institute invited me to join their practice and assist with opening a practice in Manhattan that focused on knees, sports medicine and general orthopedics.”

Now that the practice has three offices and 10 physicians, Dr. Scuderi has had to master the non-clinical arena of practice management. “Like many physicians I have been forced to learn about the wider world of health care. A particularly important lesson is that to operate in today’s medical environment one must be incredibly organized. Whether it’s time management, billing, the review of insurance company contracts, or getting authorizations for techniques and procedures, all of your ducks must be in a row in order to keep things moving and get paid. Not to be underestimated is the importance of having the right support staff. I have been fortunate to have surrounded myself with a dedicated staff that has helped my practice grow and succeed.”

Though accomplished in practice management, Dr. Scuderi would rather be working with cartilage than contracts. “Being able to spend time on research is important for my mental stimulation. Much of my work has involved minimally invasive knee surgery. One of my findings is that while MIS for total knee replacement can be offered to all patients, there are patient-specific factors that make some people more eligible than others. For one thing, we see that MIS for knee replacement is much more common in women. In general, females are different. Their bones are smaller and their muscles, while strong, are not as developed. All of these variables mean that it’s usually easier to operate on women. One thing making knee surgery more difficult on men is that they have larger bones with more prominent quadriceps muscles and thus need longer incisions and greater exposure to perform the operation. In addition to MIS, I have published a number of studies on total knee design. Working with Dr. Richard Komistek, I have developed a high flex implant for Zimmer. There are so many baby boomers coming of age who have knee injuries and arthritis and want replacement, that we needed to design a prosthesis that would give patients a greater arc and range of flexion. We have shown in clinical results, fluoroscopic imaging, and in vivo testing that these patients can achieve flexion with well designed prostheses. It is exciting that we can restore their function, range of motion and mobility. Dr. Komistek and I were really surprised that we could restore almost normal kinematics to these patients. This work will become increasingly important because the number of total knee replacements is increasing annually.”

Perhaps this means that the surgeons could use a little space age assistance. States Dr. Scuderi, past Chairman of the Knee Society’s Research Committee, “Robotic surgery is the wave of the future. For some physicians, like cardiac surgeons, the future is already here. Currently, I am working on a technique to do total knee replacement with robotic assistance. Working with Zimmer, I am developing a product called ‘BRIGIT™,’ a computer-guided robotic arm that helps surgeons operate with limited instrumentation. We have experimented on cadavers, applied for a 510k, and showcased BRIGIT at the 2007 AAOS meeting. Fortunately, no one fled his or her seat at the meeting. I say this because traditionally we surgeons want control of the OR and are hesitant to cede power to a machine. Much of what is being developed is passive robotics, however, whereby the robot serves as an assistant to the surgeon. I always tell my colleagues, ‘Robots are not smart; you provide the intelligence.’ Indeed the brain overrides the box. The surgeon is the one who has to think through the right steps, do them in the right order, and complete the operation.”

And in his daily life, Dr. Scuderi gets to teach future surgeons how to think. The fellows he works with are blessed to learn from someone so involved with education. “I am on the Executive Board of the Knee Society as Secretary and Education Chairman. This work keeps me up to date on the latest educational needs of the society and in turn I can use this information to teach my fellows. Each year I have four American fellows, along with several international fellows who come to us for three months. These surgeons spend time with me in the operating room and office, as well as perform clinical research, much of which is presented at the AAOS Annual Meeting or published in peer-reviewed orthopedic journals. I enjoy watching the fellows develop over the year they spend with me. There is such a spirit of camaraderie here that we have created the Insall Club as a fraternity of past fellows. Each year we get together for an academic and social program and discuss new ideas, techniques, and complex cases. Some of the younger members find value in bringing their complex cases to the meeting and getting our opinions.”

Regarding the foreign fellows, Dr. Scuderi notes, “I truly enjoy sharing my experience and techniques with fellows from other cultures. When I travel abroad, they have often hosted me in their countries and share their new insights with me. For someone in an American program seeking out foreign fellows, I would recommend having a base of contacts with other countries, ensuring that you have a structured program with sufficient clinical, surgical, and research opportunities for the fellows. You also want to ensure they have a sufficient understanding of the English language, otherwise things will move slowly. A message I impart to all of my fellows is, ‘Be true to yourself and that will result in you being true to your patients.’ If you feel uncomfortable with a case, refer it rather than risk it.”

He also helps the fellows remember the importance of family. “I tell fellows, ‘Look, you don’t get the years back. Go home to your family.’ I describe myself as a devoted family man who goes the extra mile to be with his kids. There are times when I have flown to Europe and back in 36 hours to get to my one of my kid’s ball games. My supportive wife and I have three children, who are now almost grown. For leisure, I golf, play tennis, and visit with the close-knit group of friends I have had for decades.”

Dr. Giles Scuderi…flexing his mental muscles for patients and colleagues alike.