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  • ASTM
    F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
    Edition: 2015
    $93.60
    Unlimited Users per year

Description of ASTM-F3037 2015

ASTM F3037-15

Withdrawn Standard: Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)




ASTM F3037

Scope

1.1 This guide is intended as a resource for individuals and organizations involved in designing clinical trials of hip replacement systems (HRSs) including metal/polymer, metal/metal, metal/composite, metal/ceramic/polymer, metal/polymer/metal, and ceramic/ceramic bearing surfaces; semi-constrained and constrained designs; and cemented, nonporous uncemented, and porous-coated uncemented fixation.

1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of HRS devices through standardizing outcomes measures are provided for designing, reviewing, and accepting human clinical trial protocols.

1.3 This guide is intended to provide consistency in study design, review, regulatory approval, and coverage approval for hip replacement systems to the health care market.

1.4 For the purpose of this guide, an HRS is any device that is intended to replace the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term functional restoration and pain relief without major adverse events 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; hip replacement systems; HRS; HRS devices;


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F3037-15

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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