ASTM WK42908

    New Guide for Clinical Trial Design for Knee Replacement Systems (KRS)

    (What is a Work Item?)

    Developed by Subcommittee: F04.39 | Committee F04 | Contact Staff Manager



    WK42908

    1. Scope

    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.


    Keywords

    clinical trial design; knee replacement systems; KRS; KRS devices

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
    Back to Top
    Work Item Status

    Date Initiated:
    07-22-2013

    Technical Contact:
    Gregory Brown, MD

    Item:
    036

    Ballot:
    F04 (14-05)

    Status:
    Negative Votes Need Resolution