Wear, Inflammation and Clinical Performance of Total Disc Replacement
全椎间盘置换术的磨损、炎症和临床表现
基本信息
- 批准号:8435434
- 负责人:
- 金额:$ 28.86万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2010
- 资助国家:美国
- 起止时间:2010-02-18 至 2015-01-31
- 项目状态:已结题
- 来源:
- 关键词:AchievementAmericanAutopsyBiologicalCellsChronicClinicalDevicesDiagnostic radiologic examinationEquipment MalfunctionEuropeExcisionExhibitsFailureFibrocartilagesFractureGenerationsHealthcareHeterotopic OssificationHip region structureImmune responseImplantInflammationInflammation MediatorsInflammatoryInflammatory ResponseInternationalIntervertebral disc structureIntractable PainKneeLinear ModelsLow Back PainMediatingMediator of activation proteinMethodsMorphologyNecrosisOperative Surgical ProceduresOsteolysisOutcomeOutcome StudyPainPatientsPenetrationPerformancePlayPolarization MicroscopyPolyethylenesPositioning AttributeProceduresProcessProtein MicrochipsReactionRegression AnalysisReplacement ArthroplastyResearchRetrievalRoleScanning Electron MicroscopyShapesSimulateSpectroscopy, Fourier Transform InfraredSpinal FusionSurfaceTestingTimeTissuesUnited StatesVascularizationVertebral columnX-Ray Computed Tomographyalternative treatmentbiomaterial compatibilityclinically relevantcytokinedesignimplant materialin vivointervertebral disk degenerationnerve supplyoxidationparticlepreventpublic health relevancerepositoryresponsesuccesstool
项目摘要
DESCRIPTION (provided by applicant): Degenerative disc disease is a painful, disabling condition. In the 1960s, total disc replacement (TDR) was conceived as an alternative treatment to spinal fusion and the resulting complications. Now, after two decades of clinical use in Europe, and FDA approval in the US, the outcomes of TDR and implant design can be assessed. A fundamental objective of device retrieval research is to understand successful implants and assess failures through explant analysis. Failure mechanisms of TDRs may be design-related and/or result from material degradation. Potential mechanisms of device failure come from studies on total joint replacements (TJR). Many TJR failures are due to component degradation, wear debris generation and the stimulation of an inflammatory response. In contrast to TJRs, little is known about in vivo degradation or the contribution of wear debris to biologically-mediated failure mechanisms of artificial discs. We provide evidence here that TDRs exhibit surface damage such as rim fracture, delamination, polyethylene (PE) penetration and in-vivo oxidation. We have established methods to quantify linear wear and volumetric wear in TDR components using microCT analysis. Moreover, we have a method to evaluate the volume, shape and size of wear particles in periprosthetic tissues using environmental scanning electron microscopy and have shown a positive correlation between the amount of debris and the extent of the inflammatory and histopathologic changes, which { may contribute to the major reasons for TDR failure, e.g. heterotopic ossification (HO) and intractable pain. } To investigate the potential failure modes of TDRs, we propose to elucidate mechanisms of in vivo degradation and the contribution of wear debris to biologically-mediated failure mechanisms. First, we will evaluate physical changes of TDR implants to determine if there are significant differences in wear and wear rate among three TDR designs (two contemporary designs and a historical control). The physical changes that are significant with respect to implant wear will be established for the three TDR designs. Second, we will evaluate the volume, shape and size distribution of wear particles in periprosthetic tissue of retrieved TDRs and determine if these findings are significantly correlated to TDR design. Lastly, we will evaluate the inflammatory { (osteo- and neuro-inflammatory mediators) } and histological responses in periprosthetic tissues and correlate these changes to the presence of PE wear debris { and clinical TDR failure. } Successful achievement of the proposed specific aims will provide essential information about implant performance and design, { and potential biological mediators that can be targeted to prevent the loss of implant mobility and the need for revision surgery due to pain. In addition, it } will provide essential information needed for informed health care decisions.
描述(由申请人提供):退行性椎间盘疾病是一种痛苦的致残性疾病。在20世纪60年代,全椎间盘置换术(TDR)被认为是脊柱融合及其并发症的替代治疗。现在,在欧洲临床使用20年,并在美国获得FDA批准后,可以评估TDR和植入物设计的结果。器械回收研究的基本目标是通过取出分析了解成功植入物并评估失败。TDR的失效机制可能与设计相关和/或由材料降解引起。器械失效的潜在机制来自全关节置换术(TJR)研究。许多TJR失效是由于部件降解、磨损碎屑产生和炎症反应刺激。与TJR相反,对人工椎间盘的体内降解或磨损碎屑对生物介导的失效机制的贡献知之甚少。我们提供的证据表明,TDR表现出表面损坏,如边缘断裂、分层、聚乙烯(PE)渗透和体内氧化。我们已经建立了使用microCT分析来量化TDR组件中的线性磨损和体积磨损的方法。此外,我们有一种使用环境扫描电子显微镜评估假体周围组织中磨损颗粒的体积、形状和尺寸的方法,并且已经显示出碎片量与炎症和组织病理学变化程度之间的正相关性,这可能是TDR失败的主要原因,例如异位骨化(HO)和顽固性疼痛。为了研究TDR的潜在失效模式,我们建议阐明体内降解机制以及磨损碎屑对生物介导失效机制的贡献。首先,我们将评估TDR植入物的物理变化,以确定三种TDR设计(两种当代设计和一种历史对照)之间的磨损和磨损率是否存在显著差异。将确定三种TDR设计在植入物磨损方面的显著物理变化。其次,我们将评估取出的TDR假体周围组织中磨损颗粒的体积、形状和尺寸分布,并确定这些结果是否与TDR设计显著相关。最后,我们将评价假体周围组织中的炎症{(骨和神经炎症介质)}和组织学反应,并将这些变化与PE磨损碎屑的存在{和临床TDR失效}相关联。}成功实现所提出的具体目标将提供有关植入物性能和设计的基本信息,{以及潜在的生物介质,这些介质可用于防止植入物活动性丧失和因疼痛而需要进行翻修手术。此外,它还将提供知情医疗保健决策所需的基本信息。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
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STEVEN MICHAEL KURTZ其他文献
STEVEN MICHAEL KURTZ的其他文献
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{{ truncateString('STEVEN MICHAEL KURTZ', 18)}}的其他基金
Wear, Inflammation and Clinical Performance of Total Disc Replacement
全椎间盘置换术的磨损、炎症和临床表现
- 批准号:
8212061 - 财政年份:2010
- 资助金额:
$ 28.86万 - 项目类别:
Wear, Inflammation and Clinical Performance of Total Disc Replacement
全椎间盘置换术的磨损、炎症和临床表现
- 批准号:
8032484 - 财政年份:2010
- 资助金额:
$ 28.86万 - 项目类别:
Wear, Inflammation and Clinical Performance of Total Disc Replacement
全椎间盘置换术的磨损、炎症和临床表现
- 批准号:
8604374 - 财政年份:2010
- 资助金额:
$ 28.86万 - 项目类别:
Wear, Inflammation and Clinical Performance of Total Disc Replacement
全椎间盘置换术的磨损、炎症和临床表现
- 批准号:
7889527 - 财政年份:2010
- 资助金额:
$ 28.86万 - 项目类别:
Mechanics and Performance of Traceable UHMWPE Implants
可追溯 UHMWPE 植入物的力学和性能
- 批准号:
8102575 - 财政年份:2001
- 资助金额:
$ 28.86万 - 项目类别:
Mechanics and Performance of Traceable UHMWPE Implants
可追溯 UHMWPE 植入物的力学和性能
- 批准号:
7626819 - 财政年份:2001
- 资助金额:
$ 28.86万 - 项目类别:
Mechanics and Performance of Traceable UHMWPE Implants
可追溯 UHMWPE 植入物的力学和性能
- 批准号:
8449120 - 财政年份:2001
- 资助金额:
$ 28.86万 - 项目类别:
Mechanics and Performance of Traceable UHMWPE Implants
可追溯 UHMWPE 植入物的力学和性能
- 批准号:
7434553 - 财政年份:2001
- 资助金额:
$ 28.86万 - 项目类别:
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