News Release Noble Chosen to Participate in FDA Study John Noble, Jr., MD, Orthopaedic Surgeon with the Center for Orthopaedics, is one of eight physicians in the United States chosen to serve as a principle investigator in a post approval clinical study of the BHR (Birmingham Hip Resurfacing) procedure. The FDA granted approval to BHR in the United States last year without the usually stringent pre-approval requirements for clinical outcome studies in the United States. This rare exception to the normal approval process was made based on overwhelming data from Europe and Australia demonstrating outstanding results of the procedure. The survivorship of the implant was found to be at least 98% at eight years which is much better than traditional hip replacement in young patients. The FDA chose to grant approval so that patients in the U.S. would not have to wait to benefit from the new technology. However, the regulatory agency is requiring a post approval study to determine if those results can be duplicated in the U.S. As one of the first surgeons in the United States to perform BHR, Dr. Noble was selected to participate, along with three other orthopaedic surgeons trained in the U.S. and four who received their training for the procedure in Great Britain. Rather than replacing the entire hip joint, as in a total hip replacement, hip resurfacing simply shaves and caps a few centimeters of bone within the joint. The bone-conserving approach of the BHR system preserves more of the patient's natural bone structures and stability, covering the joint's surfaces with an all-metal implant that more closely resembles a tooth cap than a hip implant. This approach reduces the post-operative risks of dislocation and inaccurate leg length, and because the all-metal implant is made from tough, smooth cobalt chrome, it has the potential to last longer than traditional hip implants. The new FDA study will be a 10-year outcome analysis that examines survivability and performance of the hip implant. Dr. Noble hopes to enroll approximately 45 patients per year locally, performing the procedures at CHRISTUS St. Patrick Hospital. Not every patient needing a hip replacement is a candidate for BHR. The procedure is best suited for patients suffering from hip pain due to osteoarthritis, dysplasia or avascular necrosis, and for whom total hip replacement may not be appropriate due to their increased level of physical activity. For this reason, it is ideal for patients under age 60 who live non-sedentary lifestyles. For more information about BHR and the new FDA study, call Dr. Noble at (337) 721-7236.