On (and Off) the Record

Dear OTW Reader:

Tom Sculco, M.D. leads an international consortium…ortho insider finds Synthes punishments unfair and unwise…award for James Heckman, M.D.…new research on how hospital employment could affect communities…Dr. Peter Millett’s take on shoulder issues…and more….

Synthes Punishment: Unfair and Unwise

An engineer in the orthopedic field has been observing the controversy around the Synthes legal problems. This source tells OTW, “I don’t know the whole story…no one does. But the bottom line is that these corporate executives pleaded guilty to a misdemeanor and were sentenced for maximum punishment to a federal prison to do ‘hard time.’ My colleagues and I are shaking our heads, saying, ‘Why such harsh federal sentencing?’ They obviously want to make an example of these individuals that were in the decision making roles for the company, as well as make a loud statement to the device industry. However, there could have been many other, wiser options as far as punishment; these folks have already lost the ability to maintain their livelihood in medicine. The legal system took good people with good minds and locked them up. Why not be creative and have their sentencing involve contributing to society in a positive manner…the judicial system can take the concept of ‘community service’ and amplify it for these individuals. My hope is that it will impact the way companies and device users behave. Currently, there is really a disconnect here…physicians and surgeons are not regulated for off label use of devices and the device companies are left to police the practice of medicine. It is the device company’s responsibility to enforce on-label use and regulate the physicians and surgeons, while proving to the regulatory body that their system has been validated for every potential ‘off label’ application—this is impossible, costly, and ineffective.”

Economic Impact of Hospital Employment

Dr. Richard Iorio, the director of adult reconstruction at the Lahey Clinic Medical Center and professor of orthopedic surgery at Boston University Medical School, is undertaking some fascinating new research. He tells OTW, “The average orthopedic private practice physician employes four to six individual—and there are many orthopedic surgeons in each group. I am working with the American Association of Hip and Knee Surgeons (AAHKS) to study the impact of the loss of those total joint practices on towns around the United States. We’re looking at how much money is spent on salaries, benefits, rent, overhead, insurance, etc. We are doing a survey of the AAHKS membership—1, 100 total joint replacement surgeons—and will aim to determine how exactly being ‘absorbed’ by hospitals affects their practices. Our membership performs roughly a third of all total joints in the country, so we should have a good indication of what’s actually going on. We’re also asking the U.S. Chamber of Commerce for their input. Our goal as far as timing…get it done before the 2012 election.”

Thomas Sculco, M.D. Leads International Consortium

In 2005 Dr. Thomas Sculco, Surgeon-in-Chief at Hospital for Special Surgery, launched the International Society of Orthopaedic Centers (ISOC). Dr. Sculco tells OTW, “I started this at the recommendation of a former orthopedic fellow from Mexico, who suggested that I form a coalition of the largest orthopedic specialty hospitals in the world. We now have 17 centers on 4 continents. We meet every 18 months and share our common experiences and bring our musculoskeletal focus to bear on the issues facing the field. We take the best practices of these big centers and share them, with our first goal being to improve clinical care…followed by efforts to enhance collaborative research. For example, we are looking at various guidelines for DVT prophylaxis for joint replacement. Participants have a chance to look at these and determine how they might adjust them for their own countries. We are also examining the best methods to study retrieved failed implants and strategies for the reduction and treatment of infection. We have also established a fellowship program where the trainee spends three months at a number of the centers. What drives us? Orthopedic surgery is now global and the old days of things being done in different fiefdoms are over.”

Chinese Orthopedic Association Fosters International Cooperation

The Chinese Orthopedic Association (COA) recently held its 2011 meeting, during which time it set the stage for an international cooperation platform to promote high-level medical services through education, research and best clinical practices. The event gathered world-class experts, presidents of international orthopedic societies, presidents of more than 60 national orthopedic societies, industry opinion leaders, and CEOs of leading orthopedic companies worldwide. Efforts were also made to provide a model to developing countries and even developed countries to help them reduce medical costs and cope with the global financial crisis together. Known as the “Beijing Declaration, ” the group is moving forward under the banner of CARE: Co-operation, Advocacy, Research and Education.

SI-BONE: New Research

Paul Anderson, M.D. professor of orthopedic surgery at the University of Wisconsin, Madison, is on the Surgeon Advisory Board for SI-BONE. Dr. Anderson tells OTW, “We have implanted iFUSE, sold by SI-BONE, into nine sheep and looked at how well healing progressed…the results showed a significant increase in bone density right adjacent to the implant—indicating a positive host reaction. At the final end point—six months—90% of the SI joints [sacroiliac joint] had fused on their own. The fusion across the sacroiliac joint without decortication and bone grafting was remarkable, indicating excellent stabilization of the device. This has given us the basic science validity for the device; we are now awaiting the histologic analysis. This study has provided a proof of concept that the implant can provide stabilization and bone healing. Current studies are focusing on biomechanical effects.”

James Heckman, M.D. Honored By AOA

A former president of the American Academy of Orthopaedic Surgeons, Dr. James D. Heckman, is the recipient of the 2011 American Orthopaedic Association (AOA) Distinguished Contributions to Orthopaedics Award. The award recognizes an AOA member’s personal achievement and broad contribution to the orthopedic specialty. The award emphasizes the important contributions of key individuals in effectively confronting issues or challenges in the profession. Dr. Heckman is editor emeritus of The Journal of Bone and Joint Surgery—American.

Peter McCann, M.D. Receives Lifetime Achievement Award

The Chairman of The Department of Orthopedic Surgery at Beth Israel Medical Center, Dr. Peter McCann, has received the Lifetime Achievement Award in orthopedics from the New York Chapter of the Arthritis Foundation. The Chapter’s Lifetime Achievement Award is presented to two physicians each year (one in the field of orthopedics, the other in rheumatology) in recognition of service to the Chapter and contributions to the medical community. For the past five years, Dr. McCann—who is also editor-in-chief of The American Journal of Orthopedics—has provided his time and talents to serve the Chapter as chair of the Review Committee for the Chapter’s Research Fellowship Award in Orthopedics.

Shoulders? What to Do?

Peter J. Millett, M.D., M.Sc., Director of Shoulder Surgery at The Steadman Clinic in Vail, Colorado, has been thinking a lot lately about shoulder acromioclavicular (AC) joint reconstructions and the management of shoulder separations. He tells OTW, “There is so much controversy now…‘Should an AC joint injury be fixed surgically or treated non-operatively? If it is fixed, do it arthroscopically or open? What is the best surgical method?’ I debated recently at The Arthroscopy Association of North America, and I held the position that high grade AC joint injuries should be fixed and fixed arthroscopically. I think AC joints have historically been treated nonsurgically and many patients are frequently unhappy with that. If we have an effective, minimally invasive way of repairing them or reconstructing the joint, then patients would be likely to opt for that. Our own data is showing that we can do the surgery arthroscopically, and we can do an excellent job right now. The surgical technique is in evolution, as we strive to improve our methods to allow for earlier movement and faster recoveries. We have undertaken biomechanical studies to validate methods of fixation so that we can perform this surgery even less invasively and create stronger constructs so that rehabilitation will go more quickly for our patients.”

ORS to Hold Clinical Research Forum

The Orthopaedic Research Society (ORS) is looking forward to a fruitful event at its 2012 Annual Meeting (February 6). The Clinical Research Forum will address, “The innovation cycle: How can we avoid wrong turns?” and will examine the complexities of innovation, several different orthopedic case histories, and the lessons that can be learned. The forum will feature a highly distinguished, international faculty. The forum will include five sessions with three dedicated to an in-depth discussion of current controversies: atypical proximal femur fractures, metal-on-metal bearings, and the use of bone morphogenetic proteins. The final session will help clinical researchers understand the steps they can take to minimize adverse events and other negative occurrences.

Rare Bone Disease: New Hope

Scientists at Penn’s Perelman School of Medicine Center for Research in FOP (fibrodysplasia ossificans progressive) and Related Disorders have developed a new genetic approach to specifically block the damaged copy of the gene for a rare bone disease, while leaving the normal copy untouched. Lead author Josef Kaplan, Ph.D., postdoctoral fellow; and senior authors Eileen M. Shore, Ph.D., and Frederick S. Kaplan, M.D., both from the Department of Orthopaedic Surgery, published this new proof-of-principle approach for treating the disease, called FOP, in the online edition of Gene Therapy. FOP is caused by a mutation in the gene for ACVR1/ALK2, a bone morphogenetic protein (BMP) receptor that occurs in all classically affected individuals. The mutation increases the amount of BMP in cells to greater than normal levels, which initiates the transformation of muscles and cartilage into a disabling second skeleton of bone. Using a special type of RNA molecule engineered to specifically silence the damaged copy of the gene rather than the normal copy, the scientists restored the cellular function caused by the FOP mutation by ridding cells of the mutant ACVR1/ALK2 mRNA. Confirmatory mouse models of classic FOP must be undertaken prior to its consideration for human use.