New Technologies: Surgeons Must Take Charge!
A new review article appearing in The Journal of Bone and Joint Surgery is revisiting the topic of how new technologies enter our field. The authors, all of whom have chaired various committees for the American Association of Orthopaedic Surgeons, came together to do a workshop on the introduction of new technologies.
Stuart Goodman, M.D., Ph.D., professor of orthopedic surgery at Stanford University, told OTW, “We wanted this to cover both biomedical engineering and biological implants, with an aim toward understanding how the taking on of new technologies might affect a surgeon’s practice and patients. In particular, we wanted to be able to provide patients with more detailed information on the risks and benefits of these new technologies.
“The majority of new technologies adopted into orthopedic surgery come through the 510(k) process. And while most companies do a lot of preclinical work to establish the safety and efficacy of a technology, issues remain—for example, with metal-on-metal implants, bone morphogenetic proteins (BMPs).
“We concluded that it’s the surgeon who plays the most critical role in this process. I like to quote something that the late Professor Rik Huiskes said, namely, that ‘It is the surgeon’s responsibility to ask critical questions and to demand appropriate documentation and validation of new implants.’ This is true for biologics too. He emphasized that surgeons should demand proof of preclinical documentation on the safety and efficacy of any new technology.”
“As stated by the head of the FDA, Barbara Buch, ‘The surgeon has to put the patient’s needs above all else.’”
“As for the issue of ethical considerations related to the use of new technology, let’s take the BMP-2 studies. One of the surgeons at our hospital is editor-in-chief of The Spine Journal. When the reporting was done on some studies using BMP-2 in the spine there were conflicts of interests, underreporting of complications, and other issues that had to be investigated. It’s a good product that is fine if used by the right people in the right hands for the right indication. But a lot of the use of BMP-2 is physician directed (off label). While this is not necessarily bad, we need to be cognizant of the studies that form the groundwork for use…and some of these studies were flawed.”
(Editor’s Note: The Spine Journal review of BMP-2 studies was flawed and omitted information that would have contradicted its central thesis and hypothesis. For more information read: https://ryortho.com/2011/09/under-carragee-the-spine-journal-lives-dangerously/ and https://ryortho.com/2011/10/carrageersquos-mismeasure-of-rhbmp2-and-spine-surgeons/ and https://ryortho.com/2013/06/yales-study-challenges-carragees-mis-measure-of-bmp-2/).
“One way to bring in new technologies is to have a very limited introduction to specific centers with an infrastructure that can follow patients closely, as well as document and report on outcomes and complications. The American College of Surgeons and other groups have met in Oxford ten years ago formed the IDEAL Collaboration (Idea, Development, Exploration, Assessment, Long-Term Follow-up, Improving the Quality of Research in Surgery). The concept is that you start with an idea, develop it into something that can be preclinically tested, do a limited introduction, and only then release it to the general public.”
Genetic Trigger for Autoimmune Diseases?
New research from Hospital for Special Surgery (HSS) is indicating that virus-derived elements in DNA are a cause for concern as they relate to autoimmune diseases.
Mary Crow, M.D., physician-in-chief at Hospital for Special Surgery and senior study author, told OTW, “In considering the challenges in identifying genes that contribute to autoimmune disease, a number of years ago it occurred to me that some of the genetic risk for developing autoimmune disease might be based in variations among individuals in the so-called ‘junk’ DNA—that DNA that does not encode proteins that perform important functions in cells. I read about LINE-1 [long interspersed nucleotide elements] and wondered if virus-like genomic elements throughout the genome might be differentially regulated among individuals and contribute to the risk of autoimmune disease based on its virus-like properties. One mechanism by which the LINE-1 might promote autoimmunity could be through activation of the immune system—in a manner similar to what occurs in the setting of viral infection. It was that notion that led to the work published in the recent paper, focusing on the capacity of LINE-1 RNA to induce production of type I interferon.”
Dr. Crow said in the June 24, 2016 news release, “Our genomes are packed with sequences derived from viruses that were inserted many thousands of years ago, and these virus-like sequences can move around, causing genetic mutations and contributing to the evolution of our genomes. We hypothesized that they sometimes generate virus-like RNA sequences that can be detected by the immune system.”
Dr. Crow commented to OTW, “I have been surprised to see the striking expression of the LINE-1 protein in the ductal cells of the salivary glands from patients with Sjogren’s syndrome as well as in the tubular cells in the kidneys from patients with lupus nephritis. That observation draws attention to epithelial cells and their potential capacity to expression genomic retrotransposon products. It makes me wonder about the particular mechanisms that might account for LINE-1 expression in those cells. In addition, in studies from other investigators it has been observed that LINE-1 elements are expressed in the neurons in the central nervous system, suggesting that they might play a role in the sophisticated functions of our brains—an amazing notion.
“As we gain more understanding of how tissues are damaged and how they heal, it is recognized that immune system cells can play an important role in ways that go beyond traditional inflammatory diseases. For example, immune system cells contribute to joint disease in osteoarthritis and they are important in tendon healing. Understanding how all cells work together, as well as how those cells are activated to perform their functions—both productive and destructive—will be important in ultimately controlling tissue injury. It seems that regulation of genomic retrotransposon elements is one aspect of cell function that needs to be understood, particularly with regard to the environmental factors that activate those elements.”
HSS Radiologist Lauds Imaging System
Theodore Miller, M.D., a radiologist specializing in musculoskeletal imaging and interventional procedures at HSS, has been taken with the EOS scanners.
He tells OTW, “HSS purchased its first EOS system several years ago for use in pediatric scoliosis cases and cases of pediatric limb length discrepancy. Patients used to have to stand against a three foot long cassette while we took images of the cervical, thoracic and lumbar spine, or of the pelvis, knee, and ankles…then we would have to manually stitch those films together! Moreover, despite the radiation exposure, all we got were frontal views. EOS, in contrast, provides low dose frontal and lateral views at the same time with no distortion.”
“Before getting the EOS units, we had tried to decrease radiation exposure and eliminate manual stitching by using the ‘scout’ function of our CT scanners, but the patients were lying down rather than standing, so you lose the important information provided by weight-bearing. For example, is there really pelvic tilt and scoliosis, or is the patient just lying crooked on the scanner? It’s not clear. With EOS the patient is standing so you can see and measure limb length discrepancy and the mechanical alignment of the lower extremity, and see the spine alignment under physiologic conditions.”
“Because of these unique capabilities of the EOS unit, our hip replacement surgeons at HSS got interested in EOS for evaluation of potential hip dislocations. By getting frontal and lateral views of the spine and pelvis while the patients are sitting and then standing, we can see how the pelvis and spine move and see if the patient is at risk to dislocate. We then established a research group using EOS to look at these patients before and after hip replacements, which led to the second EOS machine at HSS. Then, when our spine surgeons saw what we were doing with the pediatric patients and the hip replacement patients, and that they could obtain full-length standing views of their adult scoliosis patients, the volume became too much for just two EOS units, so we ordered our third machine.”
thanks
need more HSS doctors on Long Island and in Delray Florida area!