FDA Study of Hip Resurfacing Device

Dr. John Noble Co-Authors Report on 10-YEAR

FDA STUDY of

Hip Resurfacing Device

by Kristy Como Armand

John Noble, Jr., MD, orthopaedic surgeon with the Center for Orthopaedics, served as one of five principal investigators in the U.S. Food and Drug Administration’s (FDA) post-approval, 10-year study of the Birmingham Hip Resurfacing (BHR) procedure. Along with other participating surgeons, he co-authored a report of the study’s results recently published in The Journal of Bone & Joint Surgery-American. The journal is the most highly regarded journal for orthopaedic surgeons globally.

The FDA approved BHR in the United States in 2006 without the usually stringent preapproval requirements for clinical outcome studies. The FDA made this rare exception to the usual approval process based on overwhelming data from Europe and Australia demonstrating outstanding results of the procedure. The FDA chose to approve the procedure so patients in the U.S. would not have to wait to benefit from the new technology. However, the regulatory agency required a post-approval clinical study to determine if the same favorable outcomes would be duplicated in the U.S. The 10-year study confirmed the same level of success in the U.S.

As one of the first surgeons in the U.S. to perform BHR, Dr. Noble was selected to participate in the multi-center clinical outcomes study. “The four other sites chosen were universities. We were the only community site. We each enrolled roughly 50 patients and tracked their progress for ten years. The patients who did best were men under 55, who wanted to remain active and did not have a metal allergy. A metal analysis test can now be done to determine the presence of a metal allergy. We didn’t have reliable testing at the beginning of the study.”

Dr. Noble adds, “I am pleased to report that the results of our 10-year study demonstrated that BHR has a 96% survivorship of the implant at 10 years’ post-procedure, with particularly successful results in younger, active male patients. This procedure gives us an ideal solution for those patients with hip pain who would be considered too young and active for a traditional hip replacement.”

Dr. Noble explains that 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. The all-metal implant resembles a cap on a tooth more closely than a hip implant. “This approach reduces the postoperative risks of dislocation and inaccurate leg length. The implant is made from tough, smooth cobalt chrome and has the potential to last longer than traditional hip implants, which is why we are so excited about the results in younger patients. I’ve found that my BHR patients have experienced significant improvement in their overall quality of life, and they can remain very active if required by their occupation.”

Not every patient needing a hip replacement is a candidate for BHR. Dr. Noble says the procedure is best suited for male patients under age 55 who suffer from hip pain due to osteoarthritis or dysplasia. Total hip replacement may not be appropriate due to their increased level of physical activity. Dr. Noble generally reserves this operation for law enforcement, firefighters, or individuals who have a strong desire to remain active.

He adds that the surgery has better results for men than women because of the difference in femoral head size. “The ideal combination between socket size and head size works better with men because of the clearance in between. This clearance allows just enough joint fluid that the head can move without friction.”

The research project was a landmark study for the worldwide orthopedic community. The Center for Orthopaedics is honored to have been a part of this study.

For more information about hip replacement and BHR, call (337) 721-7236 to schedule an appointment with Dr. Noble.