FDG-PET Imaging in painful Hip Prosthesis

描述（由申请人提供）：在美国每年大约有200,000例全髋关节置换术。尽管由于采取了一定的预防措施，髋关节置换术后急性感染的发生率降低了，但早期和晚期感染仍然是发病率、死亡率和大量费用的重要来源。感染关节置换术的治疗费用估计在每名患者5万至6万美元之间。建立感染的诊断是相当困难的，并且许多发病率和成本所遇到的是由于缺乏一个单一的测试是高度准确的，并且在管理疼痛的全髋关节假体患者的成本效益。目前的诊断测试，包括常规放射照相、实验室研究和核医学程序，在准确性和成本等方面存在重大缺陷。研究表明，[18-F]氟脱氧葡萄糖（FDG）和正电子发射断层扫描（PET）显示炎症部位具有很高的敏感性和特异性。在我们机构进行的一项试点研究中，我们已经能够在相对较小的患者群体中证明FDG-PET成像在疼痛全髋关节假体的设置中具有很高的准确性。本研究的主要目的是确定FDG-PET成像在大量患者中治疗疼痛全髋关节假体的疗效。我们还打算将FDG-PET成像直接与常规技术进行比较，包括用于诊断髋关节感染的放射性标记白细胞成像，以确定FDG-PET成像是否优于现有技术。此外，我们将优化FDG-PET成像标准诊断与髋关节假体相关的感染。我们计划在5年内招募530名患者，用于申请中概述的目的。通过实施拟议的研究，我们将能够证明这种技术在治疗髋关节置换术患者疼痛方面的有效性。我们相信这项有前景的技术在准确诊断这一严重且具有挑战性的临床问题方面具有巨大的潜力，并可能对这些患者的预后产生重大影响。

DESCRIPTION (provided by applicant): Approximately 200,000 total hip replacements are performed in the U.S. each year. Although the incidence of acute infection following hip replacement is reduced as certain preventative measures have been adopted, both early and late infections remain as significant sources of morbidity, mortality and substantial expenses. The treatment of infected joint replacements has been estimated to cost between $50,000-60,000 per patient. Establishing the diagnosis of infection is quite difficult, and much of the morbidity and cost encountered is due to the lack of a single test that is highly accurate, and cost effective in the management of patients with painful total hip prosthesis. Current diagnostic tests including routine radiography, laboratory studies, and nuclear medicine procedures, suffer from significant shortcomings including accuracy and cost. It has been shown that [ 18-F] fluorine deoxyglucose (FDG) and Positron Emission Tomography (PET) reveal sites of inflammation with high sensitivity and specificity. In a pilot study conducted at our institution, we have been able to demonstrate that FDG-PET imaging has high accuracy in the setting of painful total hip prosthesis in a relatively small patient population. The main objective of the proposed research study is to determine the efficacy of FDG-PET imaging in the management of a painful total hip prosthesis in a large patient population. We also intend to compare FDG-PET imaging directly to conventional techniques including radio labeled white cell imaging for the diagnosis of hip infection to determine whether FDG-PET imaging is superior to the existing techniques. Furthermore, we will optimize the FDG-PET imaging criteria for diagnosing infection associated with hip prosthesis. We plan to enroll 530 patients over 5 years for the purposes outlined in the application. By implementing the proposed research, we will be able to demonstrate the effectiveness of this technique in the management of patients with painful hip arthroplasty. We believe this promising technology has great potential for the accurate diagnosis of this serious and challenging clinical problem, and may substantially influence the outcome in these patients.