Tony Viscogliosi Touts PMA Over 510(k)…It’s Official! Double-Bundle Superior…Infuse Critics Guilty of Loose Talk…4 New Japanese/U.S. Fellows Announced…Amazing Clinical Success with Bone Marrow Concentrate….Interdisciplinary Team Wins Team Science Award…and more.
Amazing Clinical Success With Bone Marrow Concentrate
Lew Schon, M.D. is director of Foot & Ankle Services at MedStar Union Memorial Hospital in Baltimore, Maryland. These days, Dr. Schon is getting better, faster healing thanks to something he’s quite excited about—orthobiologics. He tells OTW, “Despite the controversies and major problems we have had with BMPs, there are still a lot of great opportunities to improve the magnitude and speed of healing with orthobiologics. I’ve being focusing on using bone marrow concentrate as a source of the body’s own stem cells, and to date have done over 1, 000 cases—and will soon begin publishing them. I am using these cells for bony healing in challenging nonunions, malunions, and reconstructions in locally or systemic compromised patients—and also for soft tissue healing. The early results show that in cases where we used bone marrow concentrate for treating tendenopathy, the success rate is better than with platelet rich plasma for peripheral blood. In cases where the patient had bilateral posterior tendinopathy or a broken Achilles tendon, I reconstructed the worst side and on the other I used bone marrow concentrate alone…the clinical success is pretty amazing.”
“This is so promising that I have cofounded a new company called Bioactive Surgical, through which we are developing stem cell sutures. So far it has been used for rats in a gap tendon model; we have shown better, faster healing with better tissue organization and mechanical properties within the gap treated with stem cell sutures over a gap treated with sutures with injections of stem cells alone.”
Nassr, Klineberg, Smith and Costouros Picked as 2012 Traveling Fellows
The American Orthopaedic Association-Japanese Orthopaedic Association (JOA) Exchange Traveling Fellowship has announced the four fellows who will be visiting top Japanese academic centers and historical landmarks for the JOA Traveling Fellowship. Ahmad Nassr, M.D. is a consultant and assistant professor of orthopedic surgery at the Mayo Clinic in Rochester, Minnesota specializing in spine surgery. He completed his residency at Rush University Medical Center and his fellowship at the University of Pittsburgh Medical Center. He received his M.D. from the University of Pennsylvania and his undergraduate degree from the Massachusetts Institute of Technology. Eric Klineberg, M.D. is an assistant professor and fellowship director for the Department of Orthopaedic Surgery at the University of California, Davis. Dr. Klineberg is a fellowship trained Orthopaedic Spinal surgeon. He attended the University of Maryland to obtain his M.D. and completed an Orthopaedic Surgery Residency at the University of Washington Medical System. In 2007, he completed his fellowship at The Cleveland Clinic Foundation for combined Neurosurgery and Orthopaedic Surgical Spine. Jordan Smith, M.D. attended medical school at the University of Washington in Seattle, and completed his residency at the University of Arizona. This was followed by fellowship training in orthopedic trauma at Carolinas Medical Center and computer navigated orthopedic surgery in Ulm, Germany. He has returned to serve on the faculty at the University of Arizona as one of four orthopedic traumatologists with a focus on pelvic and acetabular reconstruction. John Costouros, M.D. specializes in the arthroscopic and open treatment of complex shoulder disorders including sports injuries, degenerative conditions, fractures, and compressive neuropathies. He graduated with honors from Stanford University in Biological Sciences followed by medical school and residency at the University of California, San Francisco (UCSF). He completed fellowships with Drs. J.P. Warner and Christian Gerber at Harvard and the University of Zurich. He is currently assistant professor at Stanford University School of Medicine in the Department of Orthopaedic Surgery.
It’s Official! Double-Bundle Superior
Freddie Fu, M.D. is the renowned chair of the department of Orthopaedic Surgery at the University of Pittsburgh. He has recently published two papers in the American Journal of Sports Medicine on single- versus double-bundle reconstruction. Dr. Fu tells OTW, “We have published—and are currently conducting—multiple high level studies comparing the anatomic single-bundle technique with the anatomic double-bundle technique. One of our recently published studies has demonstrated that anatomic double-bundle ACL reconstruction is significantly better than conventional single-bundle ACL reconstruction and superior to anatomic single-bundle reconstruction. These studies are important in order to begin to understand and to appreciate the significance of reconstructing the native anatomy of each individual patient and to change the surgical paradigm.”
“Recently, the editors of one of the leading scientific journals in our field, Arthroscopy, called for high level studies that would prospectively compare anatomic single- and double-bundle reconstructions. In a letter to the editor written by our head of clinical research, Dr. James Irrgang, we were happy to be able to reply directly that we are in the middle of a NIH [National Institutes of Health] funded trial that does exactly that. The purpose of this randomized clinical trial is to determine whether double-bundle ACL reconstruction is better than single-bundle ACL reconstruction in terms of dynamic knee function and clinical outcomes. For this trial we are prospectively randomizing patients with an ACL size that we can restore with both single- and double-bundle reconstruction. Since the clinical exam alone oftentimes is unable to pick up on differences in knee function between the two, Dr. Scott Tashman has developed a machine (one of only a few of its kind worldwide) that can measure in vivo knee kinematics very accurately.”
“In general, the goal that we set for ourselves is to provide the patient with the best potential for a successful outcome. In orthopedic surgery this starts with approximating the native anatomy as closely as possible. Individual anatomical characteristics should be meticulously identified and objectified before and during surgery and should ultimately be restored with respect to size, shape and function.”
Tony Viscogliosi: Touts the 4P’s – PMA Preferred so Payers Pay
Tony Viscogliosi, founder and executive chairman of Small Bone Innovations (SBi), has been thinking a lot lately about clinical superiority. Viscogliosi, whose company owns the STAR Ankle, tells OTW, “First of all, insurers, surgeons, hospital purchasing authorities and workers compensation consultants are increasingly responding to the government’s call to prove comparative effectiveness before paying for innovative treatments. The fact is that investing in the FDA’s Premarket Approval (PMA) pathway with well-researched and clinically proven technologies is vastly better than the conventional 510(k) option because the latter is all about equivalency and not clinical superiority.”
“Today’s ankles are based on 510(k) clearances that required—then and now—use of cement to implant the device. Why aren’t these devices that existed prior to 1976 available anywhere else in world today? Because they didn’t work effectively and did not last, leading to their withdrawal from the market. So why would patients be implanted with 510(k) technologies that are based upon a heritage of failure? With the STAR, payors are recognizing the difference between a clinically proven PMA ankle technology versus the 510(k) equivalents.”
“Payers are looking for solutions superior to fusion—the existing gold standard. We own the only technology to achieve that goal with the STAR Ankle’s independently documented superiority to fusion. No other total ankle device can make that claim and that’s why the STAR is getting exclusivity in the market as a preferred solution. It is a reward for the tens of millions of dollars SBi spent on development and rigorous clinical trials. In the new era of comparative effectiveness, manufacturers do have an obligation to bring to market what works. Unfortunately, the bigger companies have not fully embraced the value of demonstrating clinical superiority.”
“The STAR is a great example of a gamble on funding clinical research in an unproven market that suddenly, when research demonstrates superiority, causes market growth to explode because patients, doctors, payers and hospital purchasing committees will readily pay for something that works. It is radical from a business standpoint because it’s high risk, big return. I challenge and welcome other manufacturers to subject their products to the PMA pathway. It’s the best option for everyone so let the best technology win!”
Infuse Critics Guilty of Loose Talk
Facts, not innuendo should rule the day, says a celebrated spine surgeon. He tells OTW, “It was a big turn events when the Department of Justice (DOJ) decided that there was no cause for further action against Medtronic regarding ‘off label’ use of BMP-2. This clears the air because there has been a lot of loose talk and innuendo, with certain parties inappropriately using their pulpits to deliver accusations of wrongdoing and conspiratorial behavior. The DOJ’s decision removes the unscientific ‘guilty by media trial’ bit from the conversation and allows us to get back to fact driven scientific dialogue about the place for BMP and related technologies in responsible patient care. The issues of potential carcinogenesis at high doses are importantly undergoing further independent scrutiny. We all await further data and objective input to the discussion. As for the issue of retrograde ejaculation being BMP versus exposure related…there was one article published and trumpeted to the media by the author/editor. That led to a slew of coverage in the lay press that was unprecedented and inappropriate. That one paper’s findings based on clinical observations at one institution were presented to the media as if they were fact is disappointing. Moreover, where was the press coverage of more recent studies which refute that conclusion? In a true scientific dialogue one set of observations doesn’t carry the day. An accumulated body of data/observations will ultimately lead to consensus. In this age of mass media and sensationalism, we must try to safeguard the scientific method.”
Interdisciplinary Team Wins Team Science Award
Researchers from four institutions—Weill Cornell, Hospital for Special Surgery (HSS), University of Massachusetts Medical School and Mathematica Policy Research—have won a prestigious award recognizing the team’s success in translation of research discoveries pertaining to perioperative outcomes in orthopedic surgery into clinical practice. The team, which included Dr. Alejandro Della-Valle, an orthopedic surgeon at HSS, was recognized for studying various aspects of the perioperative epidemiology including the incidence, risk factors and trends of morbidity and mortality, changes in the population receiving care and outcomes associated with different orthopedic surgical approaches and anesthetic techniques. Looking first at bilateral total knee replacement, the researchers discovered that the procedure carries a three-fold adjusted risk for in-hospital mortality, even when performed on younger and healthier patients. Moreover, the researchers found that staggering the procedure across several days produced even greater risk for morbidity and mortality. As a result, HSS revised its guidelines on who is an appropriate candidate for same stage bilateral knee replacement surgery and who would benefit from having two procedures staged months apart. HSS also discontinued the protocol of staging procedures only days apart. The team moves forward now with an effort to develop national guidelines, and will host a symposium at HSS this September.”
