Study Finds NO Intentional Medtronic BMP Bias
His national database work was nominated for “Best Clinical Paper” at NASS. Kern Singh, M.D. an orthopedic surgeon with Midwest Orthopaedics at Rush who says that he has NO involvement with Medtronic, has found no intentional bias on the part of the company or in the studies it sponsored. Dr. Singh tells OTW,
“My colleagues and I used Medicare data, as well as a hospital database registry to look at trends in BMP from 2000-2011. This work, published recently in Spine, revealed a dramatic increase in the utilization of off-label BMP in back and neck surgeries. It was clear that after the FDA warning letter of 2008 there was a downward trend in the use of BMP in the cervical spine. Due to litigation concerns we are seeing a downturn in all uses of BMP because doctors are afraid that they would be sued for using it despite its effectiveness.”
“Then we decided to look at cost. Oddly, we saw an increase in the cost of BMP to hospitals from 2002 to 2011…even though the pricing of BMP had not changed. We had assumed that it would be viewed as a commodity with time, i.e., it would experience a valuation decrease, but that was not the case. Then we examined things from a different perspective. We conducted a systematic review of all BMP papers as related to spine from all possible angles—front, side, lateral—and did an analysis and categorization of the papers. We looked to see if the study was sponsored by Medtronic, if the surgeon was paid by Medtronic, and compared it to the date from non-conflicted studies.”
“To our surprise, we found that the complication rates were similar whether or not there was a conflict of interest. Essentially, from the published papers we did not find any intentional bias in the reporting of complications whether the surgeon had Medtronic relationships or not. This is contrary to the subtle innuendos that have been implied.’”
“The bottom line is that Medtronic probably did not do as good a job of elucidating potential complications. Some of this may have been due to the FDA limitations of a company discussing off-label applications. At this point, unfortunately, this debate has developed into more of a personal attack as opposed to a scientific debate. And we can’t ignore this question: ‘Why, as BMP has become more of a commodity, has the price not decreased?’ From a neutral and unbiased perspective no one party is damned, but all of these things happening in concert has resulted in this negative situation.”
Massive Study Looks at Sports Injury Patterns
To get to the bottom of sport-specific injury patterns you need large numbers…like 10, 958. Researchers from Kaiser Permanente Medical Center in California have reached this lofty “N” by combining two ACL reconstruction registry cohorts, from Norway and the United States, from 2004 to 2011. Gregory Maletis, M.D., an orthopedic surgeon with Kaiser Permanente, told OTW,
“This is the first time that a study has been able to look at these injuries using such a large cohort. My colleagues and I set out to see if sports injury patterns associated with knee injuries after certain sports would be different. Our hypothesis was that they would be because of the differing forces on the knees in various sports.”
“We found that soccer was the most common sport to involve an injury thus that became our reference point. We found that basketball players sustained more lateral meniscus tears and cartilage injuries as compared to soccer players; American football players were more likely to experience multiple ligament injuries. The reason for the difference is most likely the forces on the knee at the time of injury.”
“While we suspected some differences would emerge, we did not anticipate the differences between basketball and soccer injuries. Many basketball injuries occur when the player lands on a hard surface—especially when the player is off balance. That mechanism of injury is more likely to involve a compression type injury causing damage to the cartilage and meniscus; soccer typically involves a noncontact injury where the player is running and suddenly pivots.”
$1 Million to Jefferson Orthopedics for Joint Research
A team of researchers in Philadelphia has received a major grant from the Department of Defense (DoD) in order to help create new treatments that could promote recovery and restoration of joint function for members of the military who sustain traumatic combat or combat-related injuries. In 2008, Jefferson researcher Andrzej Fertala, Ph.D., and colleagues discovered an antibody that curtailed the production of collagen fibrils after trauma. Now, he and his team will engage in this pre-clinical study to examine the effectiveness of the antibody in models that mimic post-traumatic joint stiffness. The models will post-operatively receive the antibody and will then be evaluated for its effectiveness through the measurements of collagen content and ROM of analyzed joints. Appropriate controls, which include a group treated with control antibody and a group treated with an anti-inflammatory agent, will be also employed. The team notes that the long-range objective is to reduce the joint stiffness-associated fibrosis that will help maintain the correct range of motion following joint trauma, and also prevent a long-term risk of developing osteoarthritis for the men and women of the military who sustain traumatic combat and combat-related injuries during their service. Dr. Fertala told OTW, “Our first priorities are to install a bioreactor to produce inhibitory antibodies. In addition, we will soon begin the animal-based studies; during this process participating surgeons will establish a rabbit-based experimental model.”
$2 Million to Penn for Advanced Transplantation
Vascularized joint transfers and other vascular tissue transfers from living donors…these things just got closer to reality. A team of researchers from Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia have been awarded a $2 million grant from the U.S. Department of Defense. The grant is part of the Restorative Transplantation Research Cooperative Agreement (RTR)—a $9.3 million consortium led by researchers at Emory University provided through the DoD’s Clinical and Rehabilitative Medicine Research Program. L. Scott Levin M.D., FACS is chair of Orthopaedic Surgery at the University of Pennsylvania. Dr. Levin, Professor of Surgery (Plastic Surgery), tells OTW,
“These funds will help us push forward in the area of vascularized composite allo-transplantation (VCA), a procedure which gives those who have lost limbs a new lease on life. But the world of VCA is complex, and requires a seamless collaboration amongst transplant, trauma, orthopedic, and plastic surgeons.”
“While at this time there are few orthopedic surgeons involved in VCA, there is, however, an enormous potential for this technology. Even with the typical immunosuppressive issues there remains a great opportunity for reconstructive surgery to aid in, for example, a destroyed elbow in a young person…something for which we currently have no good options. Conventional allograft has problems, and implant arthroplasty will not hold up long term. If we can transplant a living joint that could be a lifelong solution.”
“These operations rely heavily on microsurgical skills—something that is waning in orthopedics. My hope is that once we perfect VCA beyond hand and arm, then my orthopedic colleagues will again turn their attention toward microvascular surgery. We and others have had great success with VCA procedures, thus the ultimate goal for this new research will be to elevate VCA to the level of an established therapy.”
