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Innovations in design and technology. The story of hip arthroplasty.
Amstutz, H C.
Afiliação
  • Amstutz HC; Joint Replacement Institute, Los Angeles, CA 90007, USA.
Clin Orthop Relat Res ; (378): 23-30, 2000 Sep.
Article em En | MEDLINE | ID: mdl-10986970
ABSTRACT
The current study reviews the early history of surgeon-initiated trial and error development in hip joint arthroplasty and the subsequent methodological evolution to proper criteria for hypothesis testing using bioengineers and other research scientists. The interplay and relationships to industry, universities, scientific organizations, and the Food and Drug Administration with respect to device development in hip arthroplasty are reviewed. The ethics of and responsibilities to involved parties are outlined, citing the history of many contemporary developments. Examples are provided from the evolution and introduction of unsuccessful innovations, and the problems inherent in the current methodology of the approval process from the Food and Drug Administration using the 5-10K, Investigative Device Exemption, and the Pre-Market Approval protocols. The pros and cons of randomized trials for devices are outlined with the conclusion that they are not appropriate for device introduction. The proper, rational methodology for introduction of new devices is a phased-in clinical trial process after pertinent bench testing. Finally, the ethical dilemmas created by managed care are addressed. Industry involvements of the surgeon-spokesmen are cited.
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Difusão de Inovações / Prótese de Quadril Tipo de estudo: Clinical_trials / Guideline / Sysrev_observational_studies Aspecto: Ethics Limite: Humans Idioma: En Revista: Clin Orthop Relat Res Ano de publicação: 2000 Tipo de documento: Article País de afiliação: Estados Unidos
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Difusão de Inovações / Prótese de Quadril Tipo de estudo: Clinical_trials / Guideline / Sysrev_observational_studies Aspecto: Ethics Limite: Humans Idioma: En Revista: Clin Orthop Relat Res Ano de publicação: 2000 Tipo de documento: Article País de afiliação: Estados Unidos