Magnetic Resonance Imaging as a Biomarker For Adverse Local Tissue Reaction In In

描述（由申请人提供）：使用金属对聚乙烯（MOP）关节面材料的全髋关节置换术（THA）具有极佳的生存率，但植入物失效的常见原因是对磨屑的生物反应导致的无菌性松动。开发了替代关节面，如陶瓷和金属，作为MOP的替代品，以减少聚乙烯磨损引起的骨质溶解。最初提倡使用金属对金属（Metal-on-Metal，Hip）髋关节表面置换术（HRA）植入物，因为其明显优于MOP;然而，由于局部不良组织反应，对扩张胶囊中的磨损碎屑的反应已成为植入物过早失效的常见原因。此外，监测对植入物的局部反应需要高软组织对比度，因为不良反应是由宿主滑膜反应产生的。磁共振成像（MRI）具有上级软组织对比度，但传统上受到组件产生的伪影的限制。在本研究中，我们建议开发MRI作为生物标志物，以检测THA中所有关节面组合和组配式连接的不良局部组织反应。将招募适用于翻修THA手术的个体进行术前MRI研究、术中MRI研究和随访。 组织取样用于组织学分析，以及取出植入物的术后磨损分析。将进行MRI数据集与组织学和磨损评估之间的相关性，并将其用于开发用于THA患者管理的预测性诊断工具。该预测工具将应用于初次THA患者队列，以纵向监测具有不同个体风险因素和植入物关节面的患者的疾病进展。

DESCRIPTION (provided by applicant): Total hip arthroplasty (THA) with metal-on-polyethylene (MOP) bearing materials have excellent survival rates but a common cause for implant failure is aseptic loosening caused by biologic reaction to wear debris. Alternative bearing surfaces, such as ceramics and metals, were developed as an alternative to MOP to reduce osteolysis due to polyethylene wear. The use of metal-on-metal (MOM) hip resurfacing arthroplasty (HRA) implants was initially advocated due to the perceived advantages over MOP; however, reactions to MOM wear debris in the expanded capsule have become a common cause of premature implant failure due to adverse local tissue reactions. Furthermore, monitoring local response to an implants requires high soft tissue contrast, as the adverse reactions are generated by the host synovial response. Magnetic resonance imaging (MRI) has superior soft tissue contrast but has traditionally been limited by the artifact generated by the components. In this study, we propose to develop MRI as a biomarker to detect adverse local tissue reactions for all bearing combinations and modular connections in THA. Individuals indicated for revision THA surgery will be recruited for pre-operative MRI studies, intra-operative tissue sampling for histologic analysis, and post- operative wear analysis of the retrieved implant. Correlations between the MRI datasets and the histologic and wear assessments will be performed and will be used to develop a predictive diagnostic tool for the management of THA patients. This predictive tool will be applied to cohort of individuals with primary THA to longitudinally monitor disease progression in patients with different individual risk factors and implant bearing surfaces.