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Orthopaedic Surgeon John Noble, Jr., MD, with the Center for Orthopaedics, was a speaker at the recent Louisiana Orthopaedic Association’s annual meeting in New Orleans. Dr. Noble presented early data from an FDA post approval clinical study of BHR (Birmingham Hip Resurfacing). He is one of eight physicians in the United States chosen to serve as a principle investigator in this 10-year outcome study which began two years ago.
Rather than replacing the entire hip joint, as in a total hip replacement, BHR is a bone-conserving approach that preserves more of the patient’s natural bone structures, covering the joint’s surfaces with an all-metal 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 may have the potential to last longer than traditional hip implants.
The FDA granted approval to BHR in the United States in 2006 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 with the procedure. The survivorship of the implant was found to be 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, but required a post-approval study to determine if the same type of results could be duplicated in the United States.
At the conference, Dr. Noble reported on the patients he has enrolled in the study, as well as those that are not. Although the data is too new to make significant conclusions, he has found that his patients are definitely experiencing significant improvement in their clinically measured hip scores, as well as overall quality of life.
For more information about BHR, call Center for Orthopaedics at (337) 721-7236. |
