Unprecedented international effort to improve safety of orthopedic devices

(Press-News.org) NEW YORK (Dec. 21, 2011) -- Responding to a need for better post-market surveillance of orthopedic devices, the U.S. Food and Drug Administration (FDA) established the International Consortium of Orthopaedic Registries (ICOR) in October 2010.

As outlined in a Dec. 21 special online supplement in the Journal of Bone and Joint Surgery, ICOR is in the process of developing a collaborative process for improving the safety of orthopedic devices using outcomes registries from the U.S. and other countries. The combined ICOR registries may include data on millions of orthopedic surgical procedures and all implantable devices on the market.

More than 700,000 joint replacement devices are implanted in patients in the U.S. every year, and this volume is projected to increase twofold for hip-joint replacements and sevenfold for knee-joint replacements, to a total of more than 3 million annually, in the 20 years.

While there have been dramatic advancements in orthopedics, including new devices and improved surgical techniques, the value of many of these devices has not been established using large studies in real-world settings. The FDA chair of the meeting Dr. Danica Marinac-Dabic and ICOR meeting co-leads Dr. Art Sedrakyan (NewYork-Presbyterian/Weill Cornell and Hospital for Special Surgery) and Elizabeth Paxton, M.A., (Kaiser Permanente) believe that the consortium will help ameliorate this problem.

Unlike drugs, devices have a different path of approval that may not require conduct of clinical trials in the United States. Furthermore, adverse outcomes reporting for devices is voluntary, and the resulting data are often incomplete or inaccurate. While there is currently an effort by the American Academy of Orthopedic Surgeons to develop a large national registry, the midterm follow up will likely take several years or more, says Dr. Sedrakyan, who coordinated the supplement for ICOR and is directing the Patient-Centered Comparative Effectiveness Program. He is associate professor of public health at Weill Cornell Medical College.

For the time being, the most reliable data on devices come from large registries in the U.S. such the Kaiser Permanente Implant Registries and international registries such as those in Australia, the U.K. and Scandinavian countries that track 100 percent of device implants in those countries. While these data are complete, each registry takes a unique approach to monitoring safety.

As a result, ICOR is bringing together orthopedic surgeons, scientists and other stakeholders to establish a unified method for analyzing and reporting multinational registry data. "The result will allow us to find important differences among implants -- and thus provide important evidence to inform decision-making by physicians, hospitals and patients," say ICOR researchers.

"This collaboration provides a unique opportunity to improve patient safety worldwide by identifying the best implants for our patients," says Ms. Paxton, supplement co-author and director of Kaiser Permanente's Implant Registries, which has more than 130,000 implants registered in it.

The Journal of Bone and Joint Surgery supplement summarizes the inaugural ICOR meeting held May 9 and 10 at the headquarters of the FDA in Silver Spring, Md. A total of 14 papers (including a summary paper) report on a variety of the meeting's topics such as implant safety and methodology. Conference invitees included 73 stakeholders from 29 registries representing 14 nations. In addition, more than 25 non-registry stakeholders represented the medical device industry, the Agency for Healthcare Research and Quality, the National Institutes of Health, Centers for Medicare & Medicaid Services, academia, device regulatory agencies, device cataloging experts, insurers and other payers. The Hospital for Special Surgery was an important partner in organizing the meeting.

### In addition to Dr. Sedrakyan and Elizabeth Paxton, co-authors include Robert Namba, Tadashi Funahashi and Thomas Barber of Kaiser Permanente, San Diego; Charlotte Phillips, Thomas Sculco, Douglas Padgett and Timothy Wright of the Hospital for Special Surgery; and Danica Marinac-Dabic of the Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Md.

Kaiser Permanente Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 8.9 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, visit www.kp.org/newscenter.

Weill Cornell Medical College Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances -- including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston. For more information, visit weill.cornell.edu.