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ASTM F3108-19

(Guide)

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

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

SIGNIFICANCE AND USE
5.1 Approximately 650,000 primary total knee arthroplasties (TKAs) and 50,000 revision TKAs are performed in the United States annually (7, 8). There are between 100,000 and 200,000 anterior cruciate ligament knee injuries per year in the United States (9).
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 knee reconstructive surgery (KRS) including: (1) knee replacement systems, (2) anterior cruciate ligament reconstruction, (3) knee meniscus implants or tissue engineered medical products (TEMPs), (4) articular cartilage implants or TEMPS, (5) peri-articular knee osteotomies, (6) peri-articular knee fractures (including distal femur, patella, and proximal tibia fractures), or other knee surgeries.  
1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of KRS 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 knee reconstructive surgery to the health care market.  
1.4 For the purpose of this guide, KRS pertains to any device or TEMP that is intended to replace, resurface, reconstruct, and/or provide fixation of the knee 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-Mar-2019
ICS
03.120.30 - Application of statistical methods
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

Relations

Refers
ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
Effective Date
01-Jan-2019

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ASTM F3108-19 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive SurgeryASTM F3108-19 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
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ASTM F3108-19 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee 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: F3108 − 19
Standard Guide for
Clinical Outcomes for Clinical Trials and/or Clinical
1
Registries for Knee Reconstructive Surgery
This standard is issued under the fixed designation F3108; 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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This guide is intended as a resource for individuals and
organizations when designing clinical trials and/or clinical
2. Referenced Documents
registries and addresses the selection of patient-reported
2
2.1 ASTM Standards:
outcomes,safetyoutcomes,imagingoutcomesandothertopics
F561 Practice for Retrieval and Analysis of Medical
related to knee reconstructive surgery (KRS) including: (1)
Devices, and Associated Tissues and Fluids
knee replacement systems, (2) anterior cruciate ligament
F2809 Terminology Relating to Medical and Surgical Mate-
reconstruction, (3) knee meniscus implants or tissue engi-
3
rials and Devices (Withdrawn 2019)
neered medical products (TEMPs), (4) articular cartilage im-
F2979 Guide for Characterization of Wear from the Articu-
plants or TEMPS, (5) peri-articular knee osteotomies, (6)
lating Surfaces in Retrieved Metal-on-Metal and other
peri-articular knee fractures (including distal femur, patella,
Hard-on-Hard Hip Prostheses
and proximal tibia fractures), or other knee surgeries.
4
2.2 ISO Standards:
1.2 In this guide, methods to measure the efficacy,
ISO 12891-1 Retrieval and analysis of surgical implants –
effectiveness, and safety of KRS devices through standardizing
Part1: Retrieval and handling
clinical outcome measures are provided for designing,
ISO 12891-2:2014 Retrieval and analysis of surgical im-
reviewing, and accepting human clinical trial protocols.
plants – Part 2: Analysis of retrieved surgical implants
1.3 This guide is intended to provide consistency in study
design, review, regulatory approval, and health insurance
3. Terminology
coverage approval for knee reconstructive surgery to the health
3.1 Definitions:
care market.
3.1.1 level of evidence, n—strength of clinical evidence for
5
1.4 For the purpose of this guide, KRS pertains to any
evidence-based medicine (1).
device or TEMP that is intended to replace, resurface,
3.1.2 safety, n—the condition of being protected from or
reconstruct, and/or provide fixation of the knee joint, in part or
unlikely to cause risk or injury.
in total, as a treatment for joint disease, trauma, or dysfunction,
3.2 Acronyms:
where long-term improvement in function and pain relief
3.2.1 AAHKS—American Association of Hip and Knee
without major adverse events are the desired outcomes.
Surgeons
1.5 This standard does not purport to address all of the
3.2.2 AAOS—American Academy of Orthopaedic Surgeons
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 3.2.3 ACL—anterior cruciate ligament
priate safety, health, and environmental practices and deter-
3.2.4 AJRR—American Joint Replacement Registry
mine the applicability of regulatory limitations prior to use.
3.2.5 ASA—American Society of Anesthesiologists
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the 2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Development of International Standards, Guides and Recom- 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
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 from American 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 April 1, 2019. Published May 2019. DOI: 10.1520/ The boldface numbers in parentheses refer to the list of references at the end of
F3108-19. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3108 − 19
3.2.6 CAT—Computer
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5.1 This test method is applicable to the measurement of airborne asbestos in a wide range of ambient air situations and for detailed evaluation of any atmosphere for asbestos structures. Most fibers in ambient atmospheres are not asbestos, and therefore, there is a requirement for fibers to be identified. Most of the airborne asbestos fibers in ambient atmospheres have diameters below the resolution limit of the light microscope. This test method is based on transmission electron microscopy, which has adequate resolution to allow detection of small thin fibers and is currently the only technique capable of unequivocal identification of the majority of individual fibers of asbestos. Asbestos is often found, not as single fibers, but as very complex, aggregated structures, which may or may not also be aggregated with other particles. The fibers found suspended in an ambient atmosphere can often be identified unequivocally if sufficient measurement effort is expended. However, if each fiber were to be identified in this way, the analysis would become prohibitively expensive. Because of instrumental deficiencies or because of the nature of the particulate matter, some fibers cannot be positively identified as asbestos even though the measurements all indicate that they could be asbestos. Therefore, subjective factors contribute to this measurement, and consequently, a very precise definition of the procedure for identification and enumeration of asbestos fibers is required. The method defined in this test method is designed to provide a description of the nature, numerical concentration, and sizes of asbestos-containing particles found in an air sample. The test method is necessarily complex because the structures observed are frequently very complex. The method of data recording specified in the test method is designed to allow reevaluation of the structure-counting data as new applications for measurements are developed. All of the feasible specimen preparation techn...
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1.1 This test method2 is an analytical procedure using transmission electron microscopy (TEM) for the determination of the concentration of asbestos structures in ambient atmospheres and includes measurement of the dimension of structures and of the asbestos fibers found in the structures from which aspect ratios are calculated.  
1.1.1 This test method allows determination of the type(s) of asbestos fibers present.  
1.1.2 This test method cannot always discriminate between individual fibers of the asbestos and non-asbestos analogues of the same amphibole mineral.  
1.2 This test method is suitable for determination of asbestos in both ambient (outdoor) and building atmospheres.  
1.2.1 This test method is defined for polycarbonate capillary-pore filters or cellulose ester (either mixed esters of cellulose or cellulose nitrate) filters through which a known volume of air has been drawn and for blank filters.  
1.3 The upper range of concentrations that can be determined by this test method is 7000 s/mm2. The air concentration represented by this value is a function of the volume of air sampled.  
1.3.1 There is no lower limit to the dimensions of asbestos fibers that can be detected. In practice, microscopists vary in their ability to detect very small asbestos fibers. Therefore, a minimum length of 0.5 μm has been defined as the shortest fiber to be incorporated in the reported results.  
1.4 The direct analytical method cannot be used if the general particulate matter loading of the sample collection filter as analyzed exceeds approximately 10 % coverage of the collection filter by particulate matter.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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 appropri...

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  • Standard
    33 pages
    English language
    sale 15% off