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  • ASTM
    F2028-08(2012)e1 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
    Edition: 2012
    $103.58
    Unlimited Users per year

Description of ASTM-F2028 2012

ASTM F2028 - 08(2012)e1

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

Active Standard ASTM F2028 | Developed by Subcommittee: F04.22

Book of Standards Volume: 13.01




ASTM F2028

Significance and Use

5.1 This test method is intended to investigate the resistance of a glenoid component to loosening. Glenoid loosening is the most common clinical complication in total shoulder arthroplasty (see X1.1 ). The method assumes that loosening occurs because of edge loading, often called the rocking-horse phenomenon.

5.2 This test method can be used both to detect potential problems and to compare design features. Factors affecting loosening performance include articular geometry, flange geometry, materials, fixation design, bone quality, and surgical technique.

1. Scope

1.1 These test methods measure how much a prosthetic glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Performance is judged by the tensile displacement opposite each loaded rim after dynamic rocking.

1.2 The same setup can be used to test the locking mechanism of modular glenoid components, for example, for disassociation.

1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented fixation.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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.


2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E4 Practices for Force Verification of Testing Machines

F1378 Specification for Shoulder Prostheses

F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments


Keywords

arthroplasty; glenoid; loosening; subluxation; total shoulder replacement; arthroplasty; disassociation; glenoid; subluxation; total shoulder replacement;


ICS Code

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


DOI: 10.1520/F2028-08R12E01

ASTM International is a member of CrossRef.

ASTM F2028

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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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