Review of Controlled Clinical Studies with Ceramic on Ceramic Total Hip Replacements in the United States of America
Good quality clinical research in Orthopedic Surgery can be a difficult, expensive and lengthy process. Ideally, such clinical research should be randomized and prospective and should vary only one aspect in order to determine if the difference is responsible for better outcome verses more undesirable side effects (risk). This type of research is what was implemented with drugs due to the lack of science in the earlier part of the twentieth century. This initial lack of a demand for not only proof of efficacy for a new product, but there was often a lack of good safety testing which often meant that the product actually may have done some harm to its users. It was these safety issues that first lead to the development of the Food and Drug Administration (FDA) in the United States in 1930. Slowly and steadily over the course of that time frame, new acts and new parameters for the conduction of clinical research for pharmaceuticals came into being. The FDA was also given much power to enforce these new laws. Throughout this early time frame however, devices had been completely exempted from these laws and the FDA’s scrutiny in terms of evaluating safety and efficacy.
KeywordsCeramic Insert Ceramic Liner Ball Head Investigational Device Exemption Periprosthetic Bone Loss
Unable to display preview. Download preview PDF.
- 1.Garino, J.P: Medical device regulation by the FDA. Proceedings of the Second annual Symposia on the Wear Couple BIOLOX Forte, Stuttgart, Germany, February 1998Google Scholar
- 2.Boutin PM, Arthroplastic Total de hanche par prosthese en alumine fritte. Rev Chi Orthop 58:229–246Google Scholar
- 4.Schmalzried TP, Jasty M, Harris WH: Periprosthetic bone loss in total hip arthroplasty: role of polyethylene wear debris and the concept of the effected joint space. JBJS 74A:849–863, 1992).Google Scholar