The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Thursday and Friday, September 8 and 9, 2005 in Gaithersburg, MD.
On September 8th, the Panel made a recommendation to the Food and Drug Administration (FDA) on the approvability of the Smith and Nephew Birmingham Hip Resurfacing (BHR) System, P040033 for a hip joint metal/metal semi-constrained resurfacing hybrid prosthesis (cemented femoral component and uncemented acetabular component) intended to relieve hip pain and improve hip function in patients who have adequate bone stock and are at risk of requiring more than one hip joint replacement over their lifetimes.
In the first open public hearing, the Panel heard presentations from a manufacturers’ association and an orthopedic surgeon. The sponsor then presented its information on the safety and effectiveness of the device, and FDA reviewers summarized the data in the PMA. Two Panel members, a clinician and a statistician, gave their perspectives on the PMA data. After deliberations on the information in the submission, the Panel considered FDA’s questions. In the second open public hearing, the Panel heard a presentation from an orthopedic surgeon.
The Panel then voted three to two to recommend that FDA approve the PMA with conditions. Their recommended condition of approval was as follows: The sponsor should conduct the proposed post-approval study as presented in the PMA with the additions of clinical and radiographic evaluation at the 10-years follow-up, a statistically valid sample size, and scientifically valid success criteria
On September 9th, the Panel heard eight presentations from orthopaedic device manufacturers and professional societies on the design of clinical studies for spinal devices to treat mild to moderate low back pain. The Panel then heard FDA’s presentation which summarized common dilemmas associated with clinical trials intended to support safety and effectiveness for devices in this category, such as prosthetic nucleus replacements, interspinous spacers, and pedicle screw based stabilizing systems. A clinician consultant of the Panel opened the Panel deliberations with his perspective on this topic.
After a general discussion, the Panel addressed FDA’s four questions regarding the target populations, the study endpoints, the control populations, and study designs. The Panel’s responses to the FDA questions constituted its recommendations. The Panel concluded that it may be too early in our understanding of these devices and the diagnostic continuum for which they are intended to recommend specific clinical study guidelines for these device types. They recommended that each study design be considered on a case by case basis, depending on the device design and on the specific indication being sought. The Panel commented that it is most important that patients receive clinically appropriate care and that the studies be scientifically valid.
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