Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, 3333 North Calvert Street, Suite 400, Baltimore, MD 21218, USA.
Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, 3333 North Calvert Street, Suite 400, Baltimore, MD 21218, USA.
Foot Ankle Clin. 2024 Sep;29(3):521-527. doi: 10.1016/j.fcl.2023.12.001. Epub 2023 Dec 26.
Noninferiority studies in surgery are, by their very nature, reductionist. They use multiple variables to generate a yes or no answer about the new device being tested. A binary outcome is appropriate for a regulatory agency such as the Food and Drug Administration, but the clinical situation is more nuanced. It is critical to understand the underlying philosophies and choices that go into trial design when a surgeon is recommending a new device. In the case of Cartiva, any of 3 reasonable alternative means of defining surgical success would have altered the final outcome of the MOTION trial. Additionally, using a more rigorous noninferiority margin rather than adding an additional cushion based upon the argument that motion alone had extra inherent value would have also led to failure of the trial to demonstrate noninferiority.
外科手术中的非劣效性研究本质上是简化论的。它们使用多个变量来对正在测试的新设备做出是或否的回答。对于像美国食品和药物管理局这样的监管机构来说，二项结果是合适的，但临床情况更为复杂。当外科医生推荐一种新设备时，了解试验设计背后的基本理念和选择是至关重要的。就 Cartiva 而言，任何 3 种合理的替代方法来定义手术成功，都会改变 MOTION 试验的最终结果。此外，使用更严格的非劣效性边界，而不是仅仅基于运动本身具有额外内在价值的论点增加额外的缓冲，也会导致试验未能证明非劣效性。
