The Problem With Spine Surgeons
It’s an issue in every profession. Attorneys. Physicians. Engineers. When you’re trained to use only a hammer, every problem looks like a nail. And when it comes to spine care, says one of the most insightful scientist-surgeons in America, spine surgeons are too often treating back problems as if the only solution was metal. When it comes to spine care, a Florida surgeon and entrepreneur bangs the drum loudly, but most often goes unheard…or ignored. Gaetano Scuderi, M.D., an orthopedic spine surgeon in Jupiter Florida and founder of Cytonics Corporation, says that his fellow spine surgeons are focused on implant surgery and have yet to take advantage of novel new diagnostics and biologic therapies. He tells OTW, “Whereas physicians have been extremely successful in achieving spine fusion, we all know that patient outcomes rates aren’t improving. Similarly, the industry is well aware that with epidural steroid injections (ESI) only about half of the patients experience any relief.” Dr. Scuderi’s strong belief is that the single biggest cause of the dismal outcome rates is related to the lack of diagnostic tools to assist physicians in making the correct diagnosis. “It’s not necessarily their fault because MRIs are terribly unreliable in pinpointing the source of pain. “
Dr. Scuderi indicates that he and those in his lab have discovered a diagnostic test that can dramatically improve patient outcomes. But, says Dr. Scuderi, even after extensive promotion and publication on his science few physicians have started use it. “We have published 14 articles indicating that a unique ‘pain protein’ the fibronectin–aggrecan complex (FAC), is a reliable biomarker for pain. Patients who are found to have FAC in the disc space or in their joints are more likely to improve following epidural steroidal injections. The FAC test is reported to have ~95% sensitivity and specificity for pinpointing the source of orthopedic related pain.”
“We took patients with back pain and bad-looking MRIs and aspirated their disc space. Following ESI treatment, we found that close to 100% of patients with the FAC inflammatory protein got better, whereas nearly none of the patients without FAC improved. The group that has the protein is the cohort that we can treat successfully; the other patients most likely have a different source of pain. Despite our unprecedented success in unraveling the biochemistry mystery of cartilage injuries and our development of a highly effective diagnostic, there has been very little interest generated in using our diagnostic among physicians.”
Following Scuderi’s discovery of the FAC and $9.5 million later, Scuderi and company have made major progress on a biologic therapeutic. “We received a major cash investment from one of the top orthopedic implant companies that helped us develop a ‘theranostic, ’ i.e., a diagnostic tool with a corresponding treatment based on a blood based protein called A2M (alpha-2 macroglobulin) which was proven by our lab and others to inhibit all known causes of cartilage degradation and resulting pain. Recent work from Brown University showing that A2M slows the progression of osteoarthritis has validated our years of work. Unfortunately, surgeons haven’t take advantage of the FACT diagnostic or the A2M therapeutic yet because they either haven’t heard of it or don’t have a deep enough understanding of the biologics underlying orthopedic pain to trial the system. Some are just too busy putting in pedicle screws and just haven’t taken the time to fully understand the complicated inflammatory process.”
But Dr. Scuderi knows he and his fellow researchers are on the right path. “We have new data that we will be submitting at the NASS meeting in October that shows A2M is a highly effective treatment. This new biologic has already been shown to be successful with intradiscal injections when used in conjunction with the FAC diagnostic. The reality is that if we find a non-surgical solution that really works, like I know A2M does, then all of a sudden the number of fusion surgeries in this country will decrease. I can think of more than a few people who wouldn’t be interested in that. Ideally, the North American Spine Society [NASS] with all its resources will one day do a study of a larger magnitude. So far, however, I’m still waiting by the phone.”
Tweaking HSS: Todd Albert Takes on OR Efficiency
it’s pretty hard to improve on perfection, but Todd Albert, M.D. is finding a way. Dr. Albert, surgeon-in-chief and medical director at Hospital for Special Surgery (HSS), began his post in July 2014 after serving as president of the Rothman Institute. He tells OTW, “I am determined to make our operating rooms as efficient as possible. When I arrived here last summer I noticed that our ORs were at capacity and that the young surgeons—who are trying to grow their practices were having to operate on weekends or late at night. So, with the option of adding space being pretty much out of the question, I decided that we would find ways to improve on OR efficiency. HSS is known for its amazing quality, however, so we are moving forward cautiously.”
“We are evaluating everything, including start times and turnover times. When you examine start time you must dig into what exactly goes into that, namely sign in, healthcare compliance steps, the anesthesiology check, getting the room ready, etc. It is no mistake that we have taken a checklist approach from the airlines and applied it to hospitals…it works.”
“In the next six months we will likely move our surgical start times forward. We now start at 8/8:30, but we will be incrementally moving to 7:30 for three of the days and 8:00 for one other day. We are also taking steps to ensure that the time we SAY we will be in OR is the actual time that we are in the room. Each preop element will contain a time stamp and quality metrics to ensure accountability. We also have to protect our rich educational environment at HSS with education occurring every morning.”
“The other big push nationally is for 100% safety. I want it to be completely understood that people can speak up at any time if they see something that does not appear safe. We take a time out at the beginning of the operation as mandated, introduce ourselves, ensure that we have consent and that the site is properly marked. I want to know the necessary studies are available, if the side is correct, have the antiobiotics been given…and I always end with, ‘Before we proceed, is everybody comfortable?’ There is a lot of data on the dangers of an intimidating environment (we saw this with the Korean airliner that went down in part because the co-pilot was afraid to speak up). Unfortunately, most of us have a slavish adherence to autonomy and we don’t like it if someone says, ‘I have a better way.’”
“To further ensure a safe environment, I always review my notes and studies at least a day to a week before the surgery. If there are any questions then I review things with a fellow or attending; I then re-review things the morning of the surgery. When I arrive that day I go sign the patient in and make sure that we are in agreement as far as the location of the pain. I ask them if anything has changed and I make sure that they understand what I’m going to do to them. I also explain what they are going to feel like when they wake up.”
First-Ever Pediatric Elective Hand Transplant
“Failure is absolutely not an option, ” says L. Scott Levin M.D., FACS, chair of Orthopaedic Surgery at the University of Pennsylvania. Dr. Levin, professor of surgery (plastic surgery), has worked with his team for 15 months in order to prepare for the world’s first pediatric elective hand transplant. Dr. Levin tells OTW, “We are building on our experience with adults and working with our pediatric colleagues and the United Network for Organ Sharing (UNOS). They are the group that allocates hands and faces for surgery, and they require many details on the capabilities of the institution and the personnel involved in the surgery.”
“The preparation process has been extensive, including a thorough case and personnel review by the hospital’s ethics committee. We have held several surgical rehearsals during which time we learned which structures should be repaired first. We found that the bone should be addressed first, then we will vascularize the extremity, then address the remaining tendons and nerves. In addition, we will be using custom made 3D cutting guides and bone cutting jigs in order to improve accuracy. To facilitate osteosynthesis once the donor is identified, we will be making use of 3D printers.”
“This effort is completely interdisciplinary and requires total preparation in order to give this young child a chance at a normal life. We have already identified another pediatric candidate (about five years old) who is a quadruple amputee. The issue is that it takes time to find donors. There are only maybe 15 kids in the U.S. per year that could be considered candidates based on size and racial features.”
