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.

You put in a new hip or shoulder implant. But what sort of life does it lead once you’ve given it over to the patient? Dr. Joshua Jacobs, Professor and Chairman of Orthopaedic Surgery at Rush University Medical Center in Chicago, answers this question in his work at the university’s implant retrieval lab.

Says Dr. Jacobs, also Director of the Section of Biomaterials Research in the Department of Orthopaedic Surgery at Rush, “Over the last several decades medical devices have been increasingly applied to the treatment of a variety of human ailments, with a robust and successful industry now surrounding the devices. The engineers and scientists who develop these products do their best to make them as functional as possible for as long as possible based on the information available. The human body is complex, however, and it is often hard to predict how an implant is going to perform. Over the years a science involving preclinical testing has arisen to predict implant performance and develop long-lasting products. For example, nearly all total joint replacement systems do well for five years; the real test is how they function beyond 10 years. And there is no way to know about the clinical performance of newly introduced products because we won’t have any long-term clinical research evaluating them for at least 10 years.”

“Thus,” continues Dr. Jacobs, “we try to predict the performance and longevity with preclinical testing. If you know the modes of failure, this can help predict how well the implants will perform. For example, in wear testing of total joint replacements, test methods are continually tweaked based on whether or not the pattern we produce in joint simulators is similar to ones that actually occur as determined by the examination of the retrieved devices. In general, the best way to know how an implant performs is to examine it after it has been used. While it would be even better to look at it while it is being used, that is not practical. Devices are normally removed after an infection or if they have loosened. This allows us to examine the device and the surrounding tissue and obtain insight into how it performs and how it did or did not follow the predictions of preclinical testing. Such retrievals also allow us to modify how these preclinical tests are done based on the observed modes of failure.”

Now back to the secret, perhaps tumultuous, lives of implanted implants. “When you remove the failed device,” says Dr. Jacobs, “there is a lot that’s happened to the implant. It’s important to figure out what are the primary events and what are the secondary events that occur in the process of failure. For that reason postmortem research is especially valuable in that it gives the investigator a sense of what the device and surrounding tissue look like when it is working well. Sometimes you can identify the failure mechanism early on before a clinical problem arises. For example, let’s say you see there is a pattern of tissue reaction that is mild in nature. Had that continued for several years, however, it may have led to the failure that we see on devices retrieved for causes such as loosening. Postmortem work allows one to observe the pathogenesis of the failure at different time points in the process.”

Despite the value of such work, the average orthopedic surgeon would be hard-pressed to find an implant retrieval lab around the corner. Dr. Jacobs: “There are probably less than 20 high-volume retrieval labs in the country. Many such labs start out in universities and medical centers and begin when investigators start to formulate scientific questions about the behavior of the device. They then establish a research program around these questions. To implement a successful retrieval lab, it is imperative to engage scientists and engineers who can formulate testable hypotheses, conduct analyses, and interpret the data. On the equipment side, you should have access to optical and electron microscopes, surface analysis tools, and equipment that enables you to conduct gross analyses and histological examinations. Any other, more sophisticated analytical equipment can be obtained by outsourcing or by establishing collaborations. Here at Rush we collaborate with academic and commercial organizations that have the more sophisticated and specialized imaging and analytical tools readily available.”

Continues Dr. Jacobs, “To conduct tissue analysis, you will need to collaborate with a pathologist. You will also want to be able to do specific tests on these tissues, which can involve electron microscopy and staining for certain biomolecules. You can look not only at the cellular composition of the tissue but at the expression of proteins and nucleic acids that can be important in the biological response. For example, you can take DNA and/or RNA that’s in the tissue and with high-throughput techniques look at the expression of various genes in the tissue. Using newer techniques, we may be able to determine whether there is a pattern of biological reactivity that’s characteristic of the failure of a device. If we can decipher the molecular pathways that are involved in implant failure, then we can identify potential therapeutic targets to block the pathway, thus preventing the failure in the first place.”

Commenting on quality, Dr. Jacobs notes, “There is limited information available governing best practices for implant retrieval labs. One fundamental is that all existing privacy statutes and IRB regulations must be followed. As far as specimen care, everything must be carefully labeled and stored appropriately. Also, you will want a comprehensive database in order to draw correlations between clinical performance and the structure and appearance of the implant.”

Drawing on his work for an example of implant retrieval success, Dr. Jacobs says, “In doing autopsy retrieval studies of total hip replacements, we noticed that certain implants used in the femur that didn’t have circumferential porous coating were associated with channels where debris migrated from the joint to the shaft of the femur, leading to bone loss. The device industry responded and now nearly all the implants available are circumferentially coated. Another example involves joint replacement components which have multiple pieces assembled interoperatively by surgeons. We learned that some connections didn’t perform well, and in fact exhibited considerable corrosion. By studying the retrieved components we were able to better understand the factors that led to the corrosion. As a result, the industry modified the design parameters and decreased the prevalence of corrosion of these multipart devices. Then there is the wear issue that is a common failure mechanism in many devices. The work of implant retrieval labs has allowed the industry to gain a deeper understanding of the process and then make implants less susceptible to oxidative degradation.”

So what do implant retrieval specialists fantasize about on their coffee breaks? Muses Dr. Jacobs, “It would be great to have a national registry effort in this area. In Northern Europe and elsewhere there are registries of patients that have had total joint replacements, so researchers can track their progress and determine the failure rate. They have the ability to determine failure rates in a large population. It would be nice to have an implant retrieval registry where large numbers of devices are available in centralized labs that can collect them and perform detailed analyses. And, if coordinated with a clinical registry, it would be very powerful indeed. Unfortunately, it would be a cumbersome, not to mention expensive, project.”

For the average surgeon knee-deep in the OR and in practice management issues, implant retrieval may not be on his or her radar screen. To those surgeons Josh Jacobs says, “Implant retrieval is a very exciting area to be a part of. You can collaborate with the labs by providing retrieved tissue and devices as well as the corresponding clinical information. This is interdisciplinary research requiring a team effort. From pathologists to surgeons to clinical research specialists and materials scientists, everyone has a specific, valuable role to play. In particular, orthopedic surgeons can bring clinical relevance to the findings. There is also the satisfaction of knowing that by participating in the process we can help to learn how devices perform. Timely dissemination of knowledge gained from retrieval studies helps to provide clinicians with a more scientific rationale for the devices they select for their patients.”

So for those surgeons who don’t have the time to invent, but want to make an impact on the wider field of orthopedics, get involved with an implant retrieval lab…you may have an impact on implant design that results in better-performing, longer-lasting implants.