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ASTM F3448-20

(Guide)

Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery

Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery

SIGNIFICANCE AND USE
5.1 Approximately 500 000 primary total hip arthroplasties (THAs) and 66 000 revision THAs are predicted to be performed in the United States in 2020 (7). There are an estimated 340 000 hip fractures per year in the United States (8).
SCOPE
1.1 This guide is intended as a resource for individuals and organizations when designing clinical trials and/or clinical registries and addresses the selection of patient-reported outcomes, safety outcomes, imaging outcomes, and other topics related to hip reconstructive surgery (HRS) including: (1) hip replacement systems, (2) hip fracture surgery, (3) acetabular fracture surgery, (4) hip arthroscopy and/or labrum repairs, and (5) peri-acetabular osteotomies, or other hip surgeries.  
1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of HRS devices through standardizing clinical outcome 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 health insurance coverage approval for hip reconstructive surgery to the health care market.  
1.4 For the purpose of this guide, HRS pertains to any device or tissue-engineered medical product (TEMP) that is intended to replace, resurface, reconstruct, and/or provide fixation of the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term improvement in function 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
31-May-2020
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.39 - Human Clinical Trials
Current Stage
Ref Project

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ASTM F3448-20 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive SurgeryASTM F3448-20 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
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ASTM F3448-20 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3448 − 20
Standard Guide for
Clinical Outcomes for Clinical Trials and/or Clinical
1
Registries for Hip Reconstructive Surgery
This standard is issued under the fixed designation F3448; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This guide is intended as a resource for individuals and 2.1 ASTM Standards:
organizations when designing clinical trials and/or clinical F561 Practice for Retrieval and Analysis of Medical
registries and addresses the selection of patient-reported Devices, and Associated Tissues and Fluids
outcomes, safety outcomes, imaging outcomes, and other F2809 Terminology Relating to Medical and Surgical Mate-
3
topics related to hip reconstructive surgery (HRS) including: rials and Devices (Withdrawn 2019)
(1) hip replacement systems, (2) hip fracture surgery, (3) F2979 Guide for Characterization of Wear from the Articu-
acetabular fracture surgery, (4) hip arthroscopy and/or labrum lating Surfaces in Retrieved Metal-on-Metal and other
repairs, and (5) peri-acetabular osteotomies, or other hip Hard-on-Hard Hip Prostheses
4
surgeries.
2.2 ISO Standards:
ISO 12891-1 Retrieval and analysis of surgical implants—
1.2 In this guide, methods to measure the efficacy,
Part 1: Retrieval and handling
effectiveness, and safety of HRS devices through standardizing
ISO 12891-2:2014 Retrieval and analysis of surgical
clinical outcome measures are provided for designing,
implants—Part 2: Analysis of retrieved surgical implants
reviewing, and accepting human clinical trial protocols.
1.3 This guide is intended to provide consistency in study
3. Terminology
design, review, regulatory approval, and health insurance
3.1 Definitions:
coverage approval for hip reconstructive surgery to the health
3.1.1 level of evidence, n—strength of clinical evidence for
care market.
5
evidence-based medicine (1).
1.4 For the purpose of this guide, HRS pertains to any
3.1.2 safety, n—the condition of being protected from or
device or tissue-engineered medical product (TEMP) that is
unlikely to cause risk or injury.
intended to replace, resurface, reconstruct, and/or provide
fixation of the hip joint, in part or in total, as a treatment for
3.2 Acronyms:
joint disease, trauma, or dysfunction, where long-term im-
3.2.1 AAHKS—American Association of Hip and Knee
provement in function and pain relief without major adverse
Surgeons
events are the desired outcomes.
3.2.2 AAOS—American Academy of Orthopaedic Surgeons
1.5 This standard does not purport to address all of the
3.2.3 AJRR—American Joint Replacement Registry
safety concerns, if any, associated with its use. It is the
3.2.4 ANCHOR—AcademicNetworkofConservationalHip
responsibility of the user of this standard to establish appro-
Outcomes Research
priate safety, health, and environmental practices and deter-
3.2.5 ASA—American Society of Anesthesiologists
mine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accor-
3.2.6 CAT—Computer Adaptive Testing
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mendations issued by the World Trade Organization Technical contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
Barriers to Trade (TBT) Committee.
the ASTM website.
3
The last approved version of this historical standard is referenced on
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and www.astm.org.
4
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F04.39 on Human Clinical Trials. 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Current edition approved June 1, 2020. Published August 2020. DOI: 10.1520/ The boldface numbers in parentheses refer to the list of references at the end of
F3448-20. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3448 − 20
3.2.7 CDRH—Center for Devices and Radiologic Health 4. Summary of Guide
3.2.8 CMS
...

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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
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A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
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1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
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1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
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1.5 The values stated in SI units are to be regarded as the standard.  
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Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
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1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

  • Guide
    34 pages
    English language
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  • Guide
    34 pages
    English language
    sale 15% off