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Coming Attractions

Aside from the large joints, what’s gaining traction in orthopedics? Well, try spine, extremities and biologics on for size.




What’s the so-called “next big thing” coming in the orthopedic space? Oh yeah, and let’s exclude the best sellers—traditional hips and knees.

So, out went the call to a variety of industry professionals, and back came a variety of viewpoints.

For instance, Eric Ledet, Ph.D., associate professor of biomedical engineering at Rensselaer Polytechnic Institute (RPI) in Troy, N.Y., said that when he looks at orthopedics and considers the areas that are still in their infancy and what areas have the biggest need for improvement, his answer is “very clearly” spine.

“I think the next big wave of technology breakthroughs and the next big push has to be in the spine,” he said, citing two primary reasons. “The first is that, according to statistics over the past couple of years, low back pain is now the No. 1 musculoskeletal burden in the U.S., overtaking osteoarthritis just over the last few years. So when we look at a drive or push from the market or from the number of patients or the size of the financial burden, those all point to spine being the biggest player.

“The second thing, which is probably most important,” Ledet said, “is that there still is so much unknown in spine from the fundamentals of pathophysiology to controversies on what types of treatments are best, which patients to treat and which not to, and even how to diagnose patients and how to diagnose their outcomes after they have had interventions done. Those are all things where there’s room for improvement.”

Asked if the focus on spine carries with it the caveat that going forward in that space, anything that’s going to be successful has to be of a less-invasive nature, he said: “Another way of answering that question is to try to move things toward shorter hospital stays for patients, and that implies interventions that are less invasive or are associated with less morbidity, so in the spine field there’s a big push toward less-invasive procedures, but the big challenge with spine is before you can do a less-invasive procedure, you have to know that even the open version is going to be effective.”

Douglas Van Citters, Ph.D., assistant professor in the Thayer School of Engineering at Dartmouth College in Hanover, N.H., said he thinks the next big thing in the profession “will likely be the resurgence of the total shoulder and reverse shoulder arthroplasties. There have been a couple of false starts in the past two decades due to a fundamental misunderstanding of the materials used for bearing surfaces, the biomechanics of the glenohumeral joint (the joint formed by the shoulder and the upper arm), and the biology of the glenoid (the shoulder socket). But advances in polymer science and a better understanding of bone biology have led to designs and concepts that are likely to lead to better patient outcomes.”

He said that successes with both total shoulder and reverse shoulder designs would allow such procedures to reach a broad group of patients, providing improved quality of life and better function.
“If surgeons, manufacturers and patients start to see these successes in the shoulder, I believe that other extremities such as elbow, ankle and wrist won’t be far behind,” he added.

Addressing the trend toward biologics, Van Citters’ colleague John Collier, the Myron Tribus Professor of Engineering Innovation in the Thayer School of Engineering, said, “I’m more encouraged toward developing cures for arthritis than in developing methods for growing healthy cartilage that we can implant into an unhealthy joint, although that approach may work for trauma patients.”

The “solution,” according to Collier, is about having fewer people with arthritis.

“We understand more about what causes arthritis and we can figure out what we can do to temper it,” he said. “It’s like heart disease. If you can change diet, you can change heart disease. I don’t know that anyone has tried to do that for arthritis yet, but it may be the case once they get in it that there are nutritional aspects, exercise aspects, physiological aspects of arthritis that you can identify so you help people out.”

Kirk Muskina, director of orthopedics, sourcing operations at Dallas, Texas-based Novation, a leading healthcare supply chain and contracting company, said that the biggest advances in orthopedics are “geared toward products that better respect the biology of the operative site, or products that will help promote bony in-growth and promote better or faster bone healing, or have fewer complications. This could include things like growth factor-coated implants or biologic coatings. Any time you put metal into the body, especially if it’s a load-bearing site—whether it be in the spine or especially in the lower extremities—it’s really a race between the bone healing or the implant failing.”

Like Ledet, Muskina foresees significant advancements taking place in the rapidly-expanding spine sector, where “minimally invasive spine procedures do seem to be growing. The other segment of that market includes things like ways to repair the disc biologically—the same concept can apply to motion preservation technologies like disc replacements. And then we talk about regenerating or re-growing cartilage in the joints. For the companies that figure that out, that will be a game-changer.”

Chad Rodine, vice president of sales and marketing for the Premier Performance Partners unit of the Charlotte, N.C.-based Premier healthcare alliance, said there are a lot of interesting things going on in the orthopedics sector right now.

“There are generic implants out there, there’s a push toward biologics, there is a push toward personalized or individualized fit, with custom cutting blocks and custom implants,” he said, “I really think if anything has the most traction out of all that, it’s probably going to be that push toward individualized medicine, especially from an adoption standpoint. The custom cutting block has really found some traction.”

Better Tools For Diagnosis
RPI’s Ledet noted that the importance of outcomes means that new designs of orthopedic products need to include better ways to measure those outcomes.

“What the future needs to have is better tools for diagnosis and that’s both better tools for diagnosis pre-operatively and better tools for monitoring post-operatively,” he said, noting that it is an area of his research and his interest. “My bias is that there is an opportunity and a need for incorporating intelligence into orthopedic implants to make them more than inert pieces of metal or plastic, to put the technology into them that would allow feedback to the treating clinician.”

Ledet said the technology exists that would allow monitoring and personalized medicine for each patient, while adding almost nothing to the incremental cost of each procedure.

“We are working on that and have come up with a solution to this problem, and there are a couple of companies that are working on solutions as well,” he said.

Given the role of monitoring outcomes going forward, there has been a lot of recent focus on registries for replacement joints.

“I think it’s important for us to look at outcomes,” Ledet said. “Over the last decade, evidence-based medicine has become the standard, and having a registry of patients and of retrieved implants drives evidence-based medicine as a justification for making changes and adding new technologies. The limitation, in my opinion, is that it’s an investment that needs to be made now, but reaping the benefits from that could take 10 years or something along that type of timeframe because you need to be able to see these trends. So you have a little bit of a paradox where you can get a lot of good information, but you’re generally going to be looking at data over a longer period of time and when you’re talking about rapid, dynamic changes in technology, these trends may not provide as much information. I do think that doing a registry is an absolute necessity, but there are some limitations in terms of what information you can glean from it and, most importantly, how quickly.”

Dartmouth’s Collier and his colleagues have done research on measuring outcomes.

“We’ve done some projects in instrumenting implants and putting in devices that will feed back information about the status of the joint and what’s going on internal to it,” he said. “I think it has a valuable potential, but I don’t know that we know much yet about interpreting the signals.”

He said, “The problem we’ve got as a community is that we should set up an incentive process to keep track of what works and what doesn’t work very well. While we run this implant retrieval program here at Dartmouth, the subset of implants we get is about one-tenth of 1 percent of all failures. The U.S. doesn’t yet have a registry, so we can’t keep track of what’s going in and how well it’s working even in the broadest sense. In the absence of that, we don’t really know as we could about what’s performing well and what’s not.”

But, Collier said, the question remains: “Who’s going to pay for it?”

He added: “Most folks think it’s a great idea to collect the information as long as they don’t have to pay for it.”

Van Citters “absolutely” agrees that new orthopedic designs need to include better ways to measure such outcomes.

“This monitoring will use a variety of modalities and will take advantage of advances in imaging, in physical data collection, and in population monitoring. All of these exist to some extent, and it isn’t necessarily the case that the research community needs to come up with even more monitoring solutions.” Instead, he said that industry, government, the medical community, the legal community and the patients need to agree that such monitoring is appropriate and beneficial to society.

“I’ve seen a number of exciting advances in instrumented implants, sophisticated wear measurement techniques, and the ongoing effort to create a national implant registry,” he said. “The tools are at our fingertips, and they simply need to be used appropriately.”

Van Citters cautioned, however, that outcomes “need to be viewed in a much broader sense. We need to get beyond just data and registries, although both are still critical. The next step is to look at patient-reported outcome measures. The payer, whether it is the patient, the taxpayer, or the insurance pool, needs to be assured that they are getting the highest value for their dollar.”

He said that value means looking not only at short- and long-term outcomes such as range of motion, improvement in pain, satisfaction with activities of daily living, and so forth, but also at reductions in patient harm, decreased cost, and increased patient and family satisfaction with the care provided.
“These metrics and others can be included in a balanced scorecard for delivery of healthcare,” he said.
Kevin Schulman, M.D., director of the Center for Clinical and Genetic Economics at Duke University in Durham, N.C., and associate director of the Duke Clinical Research Institute, said of the registries question: “I think it’s more of a life cycle issue. How are you going to have a business model where we get enough safety data to be able to go to market, and then how are you going to think about following those people over their lifetime?”

He said that the well-documented problems with metal-on-metal hips mean that you can’t just design a product and then walk away.

“I don’t think the American public wants to see that anymore,” Schulman said, “The car companies track your car; my kids’ toy companies track their toys. We’re going to have to really track people who get implantable devices and be accountable for whatever we find. I’m thinking basic: make, model, serial number, who got ‘re-dos’ and why.”

To the question of implanting sensors into a knee, Rodine acknowledged that if you compare service lines, looking at cardiac rhythm management (CRM) for example, sensors can be implanted to gather all kinds of data. But, there are limitations.

“Unlike orthopedics, 70 percent of the CRM patient population isn’t on Medicare,” he said. “I don’t think Medicare is going to get involved in widespread adoption of sensors put into implants. Is there a value there? Could be, but just what will they measure? I don’t think we’ll get anywhere near large-scale adoption of sensors in implants, at least in the next five years.”

As for seeing real registries for joint implants, Rodine said we’re on the right track.

“Registries not only are going to happen, they’re already happening,” he said. “There’s a Swedish registry; there’s an Australian registry. We don’t have anything like that in America yet, although there are individual entities that have one—[insurance company] Kaiser [Permanente] has one that’s fairly robust. I would argue that a national registry is not far from being a viable entity that will become a requirement. There’s too much risk.”

Growing, But Small, Segment
Muskina said that in the extremities segment, ankles, hands, fingers and shoulders are decent areas of growth, but, like many things, depends upon definitions.

“It all depends on how you define growth,” he said. “As far as percentage of procedures is concerned, yes, the foot and ankle group is growing roughly at a 23-percent clip annually. But if you’re looking at total volume of sales or dollar potential, it’s not nearly as high as some of the other arenas. It’s one of the more rapidly growing segments, but not anywhere the size of spine or large joints.”

Muskina said one of the problems with ankle replacement is the small size of the bone involved.
“If you look at the talus, the top bone in the ankle joint, there’s not a whole lot of room for error there. Even with the distal tibia, there is not a lot of real estate there to play with,” he said. “There are multiple companies that have an ankle implant. Wright Medical has one. DePuy, I think, has the first one that was on the market in the U.S. Small Bone Innovations is the only one that has a premarket approval for an ankle in the U.S., and that’s where they’re getting more traction, especially with the insurance payers.”

Asked about how much interest there is in personalized fit of knees, Muskina said most of the large-joint companies have some sort of approach to patient-specific instrumentation.

“In theory, it’s a great concept, primarily because it cuts down on the amount of inventory that suppliers need to carry, the amount of inventory that they need to ship, the number of trays, and the number of implants,” he said. “The downside for the hospitals right now is that it ends up being a pure additional cost to the procedure, adding roughly anywhere from $750 to $1,500. The suppliers are all pushing it as a cost-saving measure, but they’re relying on the hospitals to piece together that soft-side savings. If it gets to the point where suppliers are willing to pass some of the supply chain cost savings on to the hospitals, then it might get more traction. It also depends on what the long-term clinical outcomes are, and currently, it’s too early to get a sense of how that will pan out. That goes back to the lack of patient registry data in the U.S.”

Premier’s Rodine said a surgeon who has been doing implants for at least a couple of years beyond his fellowship “sure doesn’t need a custom cutting block in order to be able to size an implant appropriately, but the custom cutting block has a high ‘cool’ factor. It is specifically designed and molded for that patient based on their radiologic studies, so there is some traction around the cool factor.”

As for developments in the spinal sector, Rodine observed that the spine sector is like the Wild West.
“There is so much new technology, the adoption rate gets dangerous,” he said. “Surgeons are putting these products into patients without long-term trial data that’s long enough to prove efficacy. Outside of standard fusion products, I think it’s dangerous.”

As for whether growth in the spinal area will be focused on less-invasive approaches, he said “the challenge is that everybody needs to agree on a definition of what minimally invasive actually means, because you have to differentiate the marketing from what is truly less-invasive.”

Rodine said the extremities segment, especially ankles and shoulders, is an area of considerable activity.

“The extremity market has seen acceleration over the past few years, with the large orthopedic companies buying up these little guys who have niche products because they see growth there,” he said. “If you look at shoulders, with better techniques and better products, there are better outcomes. So manufacturers see that and want to pursue areas where they see growth, and there is growth in the extremity area.”

Muskina said one of the other interesting technologies that Novation is watching closely is robotic surgery.

“Hospitals are looking at a huge capital investments to bring something like robotics in. They must weigh considerations such as the number of procedures done and the boost in marketing that offering robotic surgery would provide, and whether or not those benefits will truly reimburse the cost of the device,” he said. “The companies that are in that market aren’t terribly interested in establishing national purchasing contracts at this point, so it will be interesting to see how quickly that market evolves.”

From a cost-control perspective, Ledet approaches the question as an engineer.

“As someone who develops new technology, it can be really frustrating to say, ‘Okay, I can add this new technology to an implant, whatever type of implant it may be, and it can improve outcomes but it’s going to increase the cost.’ So a lot of analyses are done and, ultimately, unless there is real justification for [the technology] reducing the overall cost of a procedure or an entire healthcare event, it does not get adopted. If it’s not getting adopted, then we’re not necessarily using the best tools that are at our disposal.”

If developers add new technology and it comes at an expense, Ledet explained, then the expense must be offset somewhere else.

“Where I think there are real opportunities for breakthroughs in orthopedic surgery is to look at the operating room (OR) and look at what happens in surgery and look beyond the implant to the entire experience in the OR and see if there are ways to design new technology that can reduce the OR time or reduce the stress on the surgeon or just make the whole surgical experience easier, either on the surgeon or on the patient or both,” he said. “If you can do something that doesn’t affect outcomes in a negative way but knocks five minutes off the surgical time, you then have justification financially for adding new technology into the procedure. If there are ways that the implant or the technology that’s used in the procedure can reduce stress or reduce OR time, that is very attractive to hospitals, surgeons, and insurers.”

Jim Stommen, retired editor of industry publication Medical Device Daily, is a freelance writer focusing on the medical product sector.