$6 Million for Device to Save Limbs
The Department of Defense (DOD) is going to war with IEDs (improvised explosive devices). With so many soldiers losing limbs, the U.S. Military is making a substantial investment in a novel research program that is resulting in a solution with—get this—degradable polymer implants. Led by Matthew Becker, Ph.D. at The University of Akron in Ohio, scientists and clinicians from Houston Methodist Research Institute (Ennio Tasciotti, PI) and Texas A&M University will utilize a new $6 million grant from the U.S. Army Medical Research and Materials Command to further their groundbreaking research. Akron Polymer Systems in Akron and Cook Biotech Inc. in West Layafette, Indiana, also are participating in the project.
Dr. Becker, a polymer science and biomedical engineering professor, gave OTW some background information: “Six years ago the Defense Advanced Research Projects Agency (DARPA) funded a project at Houston Methodist involving fracture putty repair. DARPA wanted an injured soldier taken off the battlefield and flown to Germany for a CT scan…then off to the U.S. where there would be a custom-fit polymeric material waiting for the soldier. The idea was to make it totally degradable and the bone to grow back naturally—and they wanted soldiers out of bed within three days. They knew that when these young people suffer so much trauma they can sink into a deep depression and even die.”
“Methodist worked with several different polymer groups, but couldn’t find a polymer that met all of the chemical and performance criteria including the ‘no metal support criteria.’ Brad Weiner, M.D., chief of spine surgery at Methodist, was very frustrated about the lack of materials available for these applications. I had been working with his brother, Scott Weiner, and father, Dennis Weiner, who are both orthopedic surgeons on a number of orthopedic projects since I arrived in Akron. In 2009 I was introduced to Brad and told him that we had been working on a degradable polymer system involving unique materials. We combined our efforts and came up with a short, hollow tube made of a strong, biodegradable polymer and filled with decellularized horse tendon that was developed at Methodist. Even though the initial design was crude, it worked. Eight hours after surgery, the injured sheep models with over an inch missing from their femurs were able to stand up. Four months later they had a stable normal callous formation over the scaffold, a healing mechanism that had not been seen in any other degradable polymer.”
“Of course, in order to submit the DOD proposal we needed a manufacturing partner. After being rejected by most of the major orthopedic companies, one day I was sitting in the offices of Cook Medical in Bloomington, Indiana, a company with no orthopedic division. I was bemoaning our lack of a manufacturing partner when my contact said, ’Go down the hall and have some coffee.’ Ten minutes later I was pitching the CEO of this multibillion dollar company. At the end of the conversation they said, ‘Go get some more coffee.’ Ten minutes later the CEO said, ‘We will make this for you.’ They have been a wonderful manufacturing partner, as has Akron Polymer Systems (makers of the film that goes on the iPhone6). They will be scaling up our initial project in a way that follows GMP (Good Manufacturing Practice) methods.”
“Our plan now is to use the polymer on 100 sheep for four years utilizing subtly different designs to the shell and the decellularized collagen. We need to know what the polymer breaks down into, how long it takes to resorb, how large of a defect we can fix, will the callous resolve itself like it does in a normal fracture process, etc. Inside the polymer there is a shell that goes around the bone that is a collagen sponge. One planned modification is to use different silicates and different bioactive molecules to speed healing.”
“The manufacturing will be done in roughly six to nine months, but we are likely a few years away from having the tube inserted into a human. It’s also important to note that there are great possibilities for using this polymer to regenerate other bone, including in the spine.”
HSS Study: MRI Quality All Over the Place
A patient goes to 123 Main St., has a spine MRI, and gets one diagnosis. She walks down the street to 456 Main St., has a spine MRI, and gets a different diagnosis. What’s going on? Richard Herzog, M.D., director of Spinal Imaging and chief of Teleradiology at the Hospital for Special Surgery (HSS) in New York City, wanted to dig deeper. He tells OTW, “Those of us in spine imaging know that there are real differences in quality when it comes to MRIs. Until now, it has been difficult to prove this, and hard to pinpoint how it can impact patients’ treatment paths.”
Dr. Herzog also serves as senior medical advisor for Spreemo, a company focused on improving medicine through research on quality, and connecting consumers with providers who meet higher standards of quality. Their current focus is on radiology. “People often make an effort to seek information and choose a doctor they believe will meet their needs, but they don’t give the same consideration to choosing an imaging center, ” says Dr. Herzog. “Two years ago I was approached by the CEO of Spreemo, Ron Vianu, to explore this issue of quality in imaging. Specifically, he asked: Why should a patient spend $3, 800 to get an MRI at your hospital when she can get one ‘down the block’ for $400? My initial response was, ‘There is incredible variability with respect to how imaging centers perform MRIs, which can have a dramatic impact on a patient’s diagnosis, ’ and I explained further what some of those key variables were. This led us down the path to collaborate on a clinical study to test this hypothesis and demonstrate the variability with evidence.”
“We began with an informal study by sending Vianu’s mother, who has a history of low back pain, to three imaging centers in New York City. After seeing the variability in the results, and the resulting recommendations—from physical therapy to epidural injections and surgery—we decided to embark on a formal clinical study.”
Hospital for Special Surgery and The Spreemo Quality Research Institute collaborated on the study, which involved sending one patient with back and leg pain to 10 different imaging centers in three weeks, with a control study before and after to ensure that any variability in results was due to the imaging or interpretation and not to changes in her pathology. “The results are in now, and our preliminary analysis shows substantial variation in the diagnoses reported. While this was not particularly surprising to us, this level of variability in MRI results is largely underappreciated by the broader medical community and the public.”
“A recent report released by the Institute of Medicine indicates that nearly everyone will experience at least one meaningful diagnostic error in their lifetime, and that the diagnostic error rate in the United States is at least 5% (and likely greater). When it comes to MRI imaging, we identified three key variables that determine the quality of imaging, the improvement of which may help to reduce this error rate. First, there is the equipment; MRI machines with higher magnet strengths produce superior images. Second, there are the protocols; it’s important for the MRI technicians to capture the relevant anatomy with the right sequences. Then lastly, there is the subspecialization of the person reading the images. Radiologists with a subspecialized focus on a particular part of the body are more likely to make an accurate diagnosis for that part of the body.”
“Our next paper will show the results of our study, namely, the range of diagnoses and how this may impact the trajectory of care. At the same time, I am working with Spreemo to establish Spine Centers of Excellence, where patients can be guaranteed to have their imaging performed on high-field MRI equipment, and to have their images read by the appropriately trained subspecialized radiologists, and thereby increase their chances of getting the right diagnosis, and ultimately a better outcome”
Second Fragility Fracture Risk Reduced by 40% With Osteoporotic Therapies!
Will patients who have endured one fragility fracture be less likely to have another if they are given osteoporotic therapies such as bisphosphonates? In short, ‘yes.’ Harpreet Bawa, M.D. is a fourth year orthopedic surgery resident at The University of Chicago Medical Center. He is the lead author of a study performed with Jack Weick, a third year medical student, and Douglas Dirschl, M.D. who is the chairman of Orthopaedic Surgery and Rehabilitation Medicine. The group undertook a retrospective study on data from the Truven Health MarketScan databases. The information included was from 2003 and 2012, and was de-identified, person-specific claim data. Dr. Bawa told OTW, “In addition to bisphosphonates, we included raloxifene, teriparatide, denosumab, and calcitonin in the study. Our study found that individuals on one of these therapies were significantly less likely to have a subsequent fragility fracture within three years than patients who were not on these medications. Specifically, the decrease in risk for an additional fracture for those treated were: 50% for a wrist fracture, 52% for a proximal humeral fracture, 34% for a hip fracture, and 43% for a vertebral fracture. When we considered all fractures together, we found that the subsequent fracture risk was reduced by 40%. These interventions can prevent a subsequent fracture in one out of every 27 patients treated.”
Dr. Dirschl added, “At the University of Chicago we have implemented a bone health program whereby we identify all patients over age 50 who have sustained fractures and reach out to them to provide appropriate evaluation and treatment. Our goal is to prevent future fractures, as well as raise awareness about the importance of bone health.”
