文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

脊柱植入物评估的测试方案。

Test protocols for evaluation of spinal implants.

作者信息

Goel Vijay K, Panjabi Manohar M, Patwardhan Avinash G, Dooris Andrew P, Serhan Hassan

机构信息

Department of Bioengineering, 5051 C Nitschke Hall, College of Engineering, University of Toledo, Toledo, OH 43606, USA.

出版信息

J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:103-9. doi: 10.2106/JBJS.E.01363.


DOI:10.2106/JBJS.E.01363
PMID:16595454
Abstract

Prior to implantation, medical devices are subjected to rigorous testing to ensure safety and efficacy. A full battery of testing protocols for implantable spinal devices may include many steps. Testing for biocompatibility is a necessary first step. On selection of the material, evaluation protocols should address both the biomechanical and clinical performance of the device. Before and during mechanical testing, finite element modeling can be used to optimize the design, predict performance, and, to some extent, predict durability and efficacy of the device. Following bench-type evaluations, the biomechanical characteristics of the device (e.g., motion, load-sharing, and intradiscal pressure) can be evaluated with use of fresh human cadaveric spines. The information gained from cadaveric testing may be supplemented by the finite element model-based analyses. Upon the successful completion of these tests, studies that make use of an animal model are performed to assess the structure, function, histology, and biomechanics of the device in situ and as a final step before clinical investigations are initiated. The protocols that are presently being used for the testing of spinal devices reflect the basic and applied research experience of the last three decades in the field of orthopaedic biomechanics in general and the spine in particular. The innovation within the spinal implant industry (e.g., fusion devices in the past versus motion-preservation devices at present) suggests that test protocols represent a dynamic process that must keep pace with changing expectations. Apart from randomized clinical trials, no single test can fully evaluate all of the characteristics of a device. Due to the inherent limitations of each test, data must be viewed in a proper context. Finally, a case is made for the medical community to converge toward standardized test protocols that will enable us to compare the vast number of currently available devices, whether on the market or still under development, in a systematic, laboratory-independent manner.

摘要

在植入前,医疗设备要经过严格测试以确保安全性和有效性。用于可植入脊柱设备的一整套测试方案可能包括许多步骤。生物相容性测试是必要的第一步。在选择材料时,评估方案应兼顾设备的生物力学性能和临床性能。在机械测试之前和期间,有限元建模可用于优化设计、预测性能,并在一定程度上预测设备的耐用性和有效性。在进行台式评估之后,可使用新鲜的人体尸体脊柱来评估设备的生物力学特性(例如,运动、负荷分担和椎间盘内压力)。尸体测试获得的信息可通过基于有限元模型的分析进行补充。在这些测试成功完成后,进行利用动物模型的研究,以原位评估设备的结构、功能、组织学和生物力学,这是启动临床研究之前的最后一步。目前用于脊柱设备测试的方案反映了过去三十年在骨科生物力学领域,尤其是脊柱领域的基础和应用研究经验。脊柱植入行业的创新(例如,过去的融合设备与目前的运动保留设备)表明,测试方案是一个动态过程,必须跟上不断变化的期望。除了随机临床试验外,没有单一测试能全面评估设备的所有特性。由于每项测试都有其固有局限性,必须在适当的背景下看待数据。最后,有人提出医疗界应趋向于采用标准化测试方案,这将使我们能够以系统的、独立于实验室的方式比较大量目前可用的设备,无论它们是已上市还是仍在研发中。

相似文献

[1]
Test protocols for evaluation of spinal implants.

J Bone Joint Surg Am. 2006-4

[2]
Determination of the biomechanical effect of an interspinous process device on implanted and adjacent lumbar spinal segments using a hybrid testing protocol: a finite-element study.

J Neurosurg Spine. 2015-5-1

[3]
Design and evaluation of the FlexiCore metal-on-metal intervertebral disc prosthesis.

Spine J. 2004

[4]
Finite element modeling of kinematic and load transmission alterations due to cervical intervertebral disc replacement.

Spine (Phila Pa 1976). 2011-8-1

[5]
Role of mechanical factors in the evaluation of pedicle screw type spinal fixation devices.

Neurol India. 2005-12

[6]
Effect of spacer diameter of the Dynesys dynamic stabilization system on the biomechanics of the lumbar spine: a finite element analysis.

J Spinal Disord Tech. 2012-7

[7]
Basic science of spinal instrumentation.

Clin Orthop Relat Res. 1997-2

[8]
Models that incorporate spinal structures predict better wear performance of cervical artificial discs.

Spine J. 2011-7-29

[9]
Modeling changes in intervertebral disc mechanics with degeneration.

J Bone Joint Surg Am. 2006-4

[10]
Stress analysis of the interface between cervical vertebrae end plates and the Bryan, Prestige LP, and ProDisc-C cervical disc prostheses: an in vivo image-based finite element study.

Spine (Phila Pa 1976). 2009-7-1

引用本文的文献

[1]
Impact of Habitual Flexion on Bone Formation After Spinal Fusion Surgery: An In Silico Study.

JOR Spine. 2025-7-14

[2]
Biomechanical performance of a novel zero-profile interbody cage: A cadaveric study.

PLoS One. 2025-4-29

[3]
Comparative biomechanical analysis of monocortical and bicortical polyaxial screw rod fixation in canine lumbar vertebral stabilization.

Front Vet Sci. 2025-2-12

[4]
Verification and Validation of Advanced Control Systems for a Spinal Joint Wear Simulator.

Bioengineering (Basel). 2024-8-1

[5]
In vivo study of a novel 3D-printed motion-preservation artificial cervical corpectomy construct: short-term imaging and biocompatibility evaluations in a goat model.

J Orthop Surg Res. 2024-5-28

[6]
Effect of Distal Tibiofibular Destabilization and Syndesmosis Compression on the Flexibility Kinematics of the Ankle Bones: An In Vitro Human Cadaveric Model.

Foot Ankle Orthop. 2024-5-25

[7]
In vitro coupled motions of the whole human thoracic and lumbar spine with rib cage.

JOR Spine. 2023-5-4

[8]
Biomechanical models: key considerations in study design.

OTA Int. 2021-4-15

[9]
An In Vitro Biomechanical Analysis of Contralateral Sacroiliac Joint Motion Following Unilateral Sacroiliac Stabilization with and without Lumbosacral Fixation.

Asian Spine J. 2023-2

[10]
A Dual-Screw Technique for Vertebral Compression Fractures via Robotic Navigation in the Osteopenic Lumbar Spine: An Biomechanical Analysis.

Global Spine J. 2024-7

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索