Innovations in design and technology. The story of hip arthroplasty.
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.
Palavras-chave
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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