1.1 This guide is intended as a resource for individuals and organizations involved in the design, manufacture, testing, and regulation of knee replacement systems (KRS) including unicompartmental and total knee designs; unconstrained, semi-constrained, and constrained designs; and cemented and porous-coated uncemented fixation. 1.2 In this guide, a standardized method to measure the efficacy, effectiveness, and safety of KRS devices is provided for designing, reviewing, and accepting human clinical trial protocols. 1.3 This guide is intended to provide consistency in study design, review, and approval to speed up introduction of new devices to the health care market. 1.4 For the purpose of this guide, an KRS is any device that is intended to replace the knee joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where functional restoration and pain relief are the desired outcomes. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsclinical trial design; knee replacement systems; KRS; KRS devices
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Gregory Brown, MD