Computer Assisted Surgery Not More Precise? 5.45% Injured Soldiers Have Spine Injuries. Expanded Approval for Magnetic Prosthesis…Non Coverage for Smokers Not Justified.
Computer-Assisted Surgery Not More Accurate?
Duncan Meuffels M.D., Ph.D. is an orthopedic surgeon at the University Medical Centre Rotterdam in The Netherlands. Even he was surprised by the findings of his recent study, “Computer-Assisted Surgery [CAS] is not more accurate or precise than conventional arthroscopic ACL reconstruction: a prospective randomized clinical trial.” Asked what led him to select this topic for study, Dr. Meuffels told OTW, “In my sports medicine practice I treat many patients with anterior cruciate ligament [ACL] injuries, who in general can return to their original sport. There are however, some patients who do less well and are not as satisfied with their reconstruction. The literature shows that mal-positioning of the new ACL graft is the reason for failure after an ACL reconstruction in 4 out 5 cases. I had already used computer-assisted surgery for some time for total knee replacement and had seen its potential in neurosurgery. Computer-assisted surgery gives the surgeon an extra feedback and could have additional value in choosing the right tunnel position for the ACL graft. The possibility to template before you actually position the new ACL graft and to verify the actual creating and positioning of the ACL, has great potential. It was also a good teaching tool for me and for the orthopedic surgeons I train.”
“It was a surprise and maybe even a little disappointing at first to find out with our three dimensional CT data that our actual positioning was no more accurate or precise than without the CAS. We used a CAS system that intra-operatively references to X-rays taken of the knee at the beginning of the surgery. It is possible that the acquiring or processing of the information is not fully reproducible. The templating is done on an X-ray image which is a two dimensional estimate in percentages of the size of the femur and tibia of what an ideal positioning would be. There is a lot of anatomical variance between every individual. The chosen position is an average of this variance and should possibly be tailored more to each and every individual. During surgery we already take a lot of different variables in consideration including the size of the femur and tibia, the intercondylar size and shape, the graft size, the position of the posterior cruciate ligament and the lateral meniscus. And dynamically we check for anterior impingement on the intercondylar notch. Possible adding more information with the CAS system does not improve positioning.”
“This study does not give the average orthopedic surgeon a reason to change to CAS ACL surgery or to add CAS ACL surgery to his repertoire. We have had a lot of positive response, congratulating us on a very honest and methodologically sound clinical trial. A number of surgeons are very interested in using our measuring skills to look at three dimensional positioning of the ACL tunnel and are asking us for our expertise. The orthopedic world should also be aware that there is a possible difference in what we see and what we actually do during surgery, especially arthroscopic surgery. Arthroscopic surgery and computer-assisted surgery have immense possibilities to enlarge what we see and give us a sense of accuracy and precision. We should, however, not stop checking our results and also keep a wider vision.”
5.45% of Injured Soldiers Have Spine Injuries
Captain James Blair, M.D. is an orthopedic surgery resident at the San Antonio Military Medical Center in Fort Sam Houston. He has taken on a novel project—Spinal Column Injuries Among Americans in the Global War on Terrorism. Dr. Blair tells OTW, “There are numerous studies on the extremity injuries sustained by U.S. soldiers. However, we have found that there exists a subset of these injured patients whose lives are on hold because of back and spine injuries. After extensive limb-salvage or amputation rehabilitation, many patients say, ‘Doc, I would be running or back to work again if it were not for my back.’ It turns out that this issue had never been studied; we felt we owed it to our wounded warriors…especially since there are recent studies indicating that back pain is one of the primary reasons that people are medically retired from the military.”
“We worked from a database of over 11, 000 injured service members, and found that 5.45% of them had back or spine injuries. There have been huge advances in combat casualty care, in body armor, and vehicular design—and these are saving lives. But we are seeing an increasing number of patients with severe spine or back injuries that are caused by explosives or motor vehicles (either the vehicle is hit by an IED or there is a collision).”
“We have a dataset of wartime spinal cord injuries larger than any other ever published—104. We know that there is a huge correlation between a gunshot wound to the spine and getting a spinal cord injury. So we are going to try to determine if acutely operating on a penetrating injury to the spinal cord improves neurological function-this would be hugely helpful to surgeons in the wartime theatre.”
Expanded Approval for Magnetic Prosthesis for Children With Bone Tumors
Jim Wittig, M.D. is chief of Orthopedic Oncology at Mount Sinai Medical Center in New York. He tells OTW, “Magnetic prostheses for bone sarcomas are proving to be very helpful in treating children. They are currently FDA approved for use in children with distal femur tumors, but that approval should be expanded in the next year. With this remarkable product the surgeon removes the tumor and puts in a prosthetic replacement; then the child can come to the office later as he or she is growing. The magnet spins around the leg and gear shafts turns as in a corkscrew mechanism; it takes four minutes to expand each millimeter. I have not yet expanded anyone, but I did get special permission to perform an upper tibial surgery and expansion for a girl who was in desperate need. The only alternative to this procedure is to put in a prosthesis, make an incision, use special screws to lengthen it…all the while risking infection…and of course, you have another operation later. I am publishing a surgical video wherein I broke the surgery down into each specific steps, and discussed the mechanism as well as the utility in the skeletally immature patient. There are more published outcomes in Europe, where a recent team of researcher published on a group of 20 to 30 patients; there were some instances of infection, but that is typical of any type of limb sparing surgery. This new option holds a lot of promise.”
Deny Payments for Smokers?
A spine surgeon tells OTW, “It is disconcerting that more and more of my colleagues are encountering situations where the hospital is harassing us not to use certain products or perform certain surgeries. One disturbing trend is that we are seeing insurers questioning and/or denying payment because the person is a smoker. When I get a physician on the phone from the insurance company—so, a peer to peer consult—I am being increasingly asked, ‘Did you know this person was a smoker?’ and ‘You know they are more at risk for a nonunion.’ This creeping practice is just wrong. Patients pay for this insurance and they have a right to surgery. And I can’t control their lives. I’m in the Midwest where about 80% of the population smokes here, so this should be interesting going forward. These are private patients and private insurers are playing this game…just imagine when the government gets involved.”
James Lawson and James Quella Join DJO Board
DJO Global has announced that James R. (Ron) Lawson and James Quella as new members of the Board. Mr. Quella will also serve on the Compensation Committee of the Board. Lawson, who is Chairman of the Board of IMDS, has over 35 years of experience in the orthopedic medical device industry. He is a member of the Health Care Advisory Board of Arsenal Capital Partners and a member of the board of directors of Cold Plasma Medical Technologies, a startup company specializing in the field of plasma medicine. Lawson has served in several senior management positions, including as senior vice president of Howmedica’s Worldwide Sales and Customer Service (prior to its acquisition by Stryker Corporation) and at Stryker as senior vice president of sales, marketing and product development, president emea, and group president, International and Global Orthopedics. Lawson has also been involved as an entrepreneur in several privately held businesses. Lawson retired from Stryker in 2007 and in 2008 he formed Lawson Group LLC, which provides strategic consulting services specializing in the orthopedic medical technology field.
Quella is a senior managing director and senior operating partner in the Corporate Private Equity group of The Blackstone Group, LP. Prior to joining Blackstone in 2004, Mr. Quella was a managing director and senior operating partner with DLJ Merchant Banking Partners and CSFB Private Equity. Prior to that, Quella worked at Mercer Management Consulting and Strategic Planning Associates, its predecessor firm, where he served as a senior consultant to CEOs and senior management teams, and was co-vice chairman with shared responsibility for overall management of the firm. Quella has been a member of various Private Equity company boards and currently serves as a director of Catalent, Freescale Semiconductor and Michaels Stores.
Hal Mathews, M.D. Joins Paradigm Spine
Veteran spine surgeon Hal Mathews, M.D., M.B.A. is the new executive vice president and chief medical officer at Paradigm Spine. Dr. Mathews now has global responsibility for all medical education initiatives, surgeon/faculty training functionalities. He is in charge of the strategic management of the company’s clinical, compliance and regulatory policies, as they relate to its worldwide product portfolio of spine medical devices. Dr. Mathews is a board certified orthopedic spinal surgeon who practiced spinal surgery for 22 years. He was recruited from clinical practice by Medtronic Spine and Biologics in 2005 to become their vice president of medical affairs, and later served within the capacity of vice president of clinical affairs, ultimately becoming chief medical officer. Prior to joining Medtronic, Dr. Mathews was president of MidAtlantic Spine Specialists in Richmond and Williamsburg, VA, where he owned and practiced in a private multi-disciplinary spine surgery practice. Also, prior to joining Medtronic, Dr. Mathews was an associate clinical professor of orthopedic and neurologic surgery at Virginia Commonwealth University in Richmond, Virginia. Prior to joining Paradigm Spine, Dr. Mathews was the president of Musculoskeletal, Clinical and Regulatory Advisors, LLC.
