ASTM F3207-17
(Guide)Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
Standard Guide for <emph type="bdit">in vivo</emph> Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
SIGNIFICANCE AND USE
4.1 This guide covers animal implantation methods and analysis of bone void fillers to determine whether a material or substance leads to lumbar intertransverse process spinal fusion, as defined by its ability to cause bone to form in vivo.
SCOPE
1.1 Historically, the single-level rabbit posterolateral, or intertransverse, lumbar spine fusion model was developed and reported on by Dr. Scott Boden, et. al. (Emory Spine Center for Orthopedics) and the model has been proposed as a non-clinical model which may be used to replicate clinically-relevant fusion rates for iliac crest autograft in the posterolateral spine (1, 2).2 This model is used routinely in submissions to regulatory bodies for the purpose of evaluating the potential efficacy of bone void filler materials as compared to other materials or iliac crest autograft to effect spinal posterolateral fusion. The use of this standard’s recommendations as part of a regulatory submission does not provide any guarantee of regulatory clearance and should be considered as a part of the data provided for regulatory submission.
1.2 This guide covers general guidelines to evaluate the effectiveness of products intended to cause and/or promote bone formation in the lumbar intertransverse process spinal fusion model in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents). It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of bone void fillers and/or autograft extender products in vivo. The purpose of this guide is not to exclude other established methods.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with the use of bone void fillers. It is the responsibility of the user of this standard to establish appropriate safety and health practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone-forming/promoting capabilities of the product.
1.5 This standard does not purport to address the requirements under 21 CFR Part 58 concerning Good Laboratory Practices or international standard counterpart OECD Principles of Good Laboratory Practice (GLP). It is the responsibility of the sponsor of the study to understand the requirements for conduct of animal studies whereby the data may be used to support premarket applications, including requirements for personnel, protocol content, record retention and animal husbandry.
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
Relations
Standards Content (Sample)
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: F3207 − 17
Standard Guide for
in vivo Evaluation of Rabbit Lumbar Intertransverse Process
1
Spinal Fusion Model
This standard is issued under the fixed designation F3207; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope fillers. It is the responsibility of the user of this standard to
establish appropriate safety and health practices involved in
1.1 Historically, the single-level rabbit posterolateral, or
the development of said products in accordance with appli-
intertransverse, lumbar spine fusion model was developed and
cable regulatory guidance documents and in implementing this
reportedonbyDr.ScottBoden,et.al.(EmorySpineCenterfor
guide to evaluate the bone-forming/promoting capabilities of
Orthopedics) and the model has been proposed as a non-
the product.
clinical model which may be used to replicate clinically-
1.5 This standard does not purport to address the require-
relevant fusion rates for iliac crest autograft in the posterolat-
2 ments under 21 CFR Part 58 concerning Good Laboratory
eral spine (1, 2). This model is used routinely in submissions
Practices or international standard counterpart OECD Prin-
to regulatory bodies for the purpose of evaluating the potential
ciples of Good Laboratory Practice (GLP). It is the responsi-
efficacy of bone void filler materials as compared to other
bility of the sponsor of the study to understand the require-
materials or iliac crest autograft to effect spinal posterolateral
ments for conduct of animal studies whereby the data may be
fusion. The use of this standard’s recommendations as part of
used to support premarket applications, including require-
a regulatory submission does not provide any guarantee of
ments for personnel, protocol content, record retention and
regulatory clearance and should be considered as a part of the
animal husbandry.
data provided for regulatory submission.
1.6 This international standard was developed in accor-
1.2 This guide covers general guidelines to evaluate the
dance with internationally recognized principles on standard-
effectiveness of products intended to cause and/or promote
ization established in the Decision on Principles for the
bone formation in the lumbar intertransverse process spinal
Development of International Standards, Guides and Recom-
fusion model in vivo. This guide is applicable to products that
mendations issued by the World Trade Organization Technical
maybecomposedofoneormoreofthefollowingcomponents:
Barriers to Trade (TBT) Committee.
natural biomaterials (such as demineralized bone), and syn-
2. Referenced Documents
thetic biomaterials (such as calcium sulfate, glycerol, and
3
reverse phase polymeric compounds) that act as additives,
2.1 ASTM Standards:
fillers, and/or excipients (radioprotective agents, preservatives,
E122PracticeforCalculatingSampleSizetoEstimate,With
and/orhandlingagents).Itshouldnotbeassumedthatproducts
Specified Precision, the Average for a Characteristic of a
evaluated favorably using this guidance will form bone when
Lot or Process
used in a clinical setting. The primary purpose of this guide is
E1402Guide for Sampling Design
tofacilitatetheequitablecomparisonofbonevoidfillersand/or
E1488GuideforStatisticalProcedurestoUseinDeveloping
autograft extender products in vivo. The purpose of this guide
and Applying Test Methods
is not to exclude other established methods.
F2529Guideforin vivoEvaluationofOsteoinductivePoten-
tial for Materials Containing Demineralized Bone (DBM)
1.3 The values stated in SI units are to be regarded as
F2884Guide for Pre-clinical in vivo Evaluation of Spinal
standard. No other units of measurement are included in this
Fusion
standard.
4
2.2 Federal Documents:
1.4 This standard does not purport to address all of the
21 CFR 58Good Laboratory Practice for Nonclinical Labo-
safety concerns, if any, associated with the use of bone void
ratory Studies
1
This guide is under the jurisdiction ofASTM Committee F04 on Medical and
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.44 on Assessment for TEMPs. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved June 1, 2017. Published July 2017. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3207-17 the ASTM website.
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