FDG-PET Imaging in Painful Joint Prosthesis (Protocol Amendment, Version 11, Dated 9/2005)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- SUV measurement from PET scan
研究概览
简要总结
The main objective of the proposed research study is to determine the efficacy of [18-F] Fluorodeoxyglucose (FDG) positron emission tomography (PET) in differentiating infections from other complications such as loosening in patients with painful joint prosthesis. We intend to validate and establish the necessary criteria for making such a diagnosis and determine the accuracy of the technique through comparison with other existing modalities such as white blood imaging and patient outcome. We expect that at the completion of the proposed research, the role of this novel and powerful imaging modality will be clearly defined in the management of patients with this challenging and serious complication.
详细描述
The purposes of this study are: 1. To determine the normal pattern of FDG uptake demonstrated by pet up to two years following total joint replacement surgery 2. To establish the optimal diagnostic criteria for differentiating septic from aseptic painful joint prosthesis by FDG-PET imaging and determine its accuracy 3. To compare the accuracy of FDG-PET imaging to conventional techniques for the differentiation of septic from aseptic painful joint prostheses.
We intend to enroll 100 patients per year for 5 years. These patients will be selected from more than 300 cases that undergo joint revisions at the collaborating institutions. After each patient undergoes an appropriate evaluation including history, physical examination, radiographic and laboratory evaluation, he/she will be assigned into one of the groups listed below based on the degree of suspicion of an infectious process. Every effort will be made to have approximately one-third of the patients recruited from each of the following groups.
Study Plan Study I: FDG-PET imaging in the painful partial or total joint prosthesis We intend to enroll 100 patients per year for 5 years. These patients will be selected from more than 300 cases that undergo joint revisions at the collaborating institutions. After each patient undergoes an appropriate evaluation including history, physical examination, radiographic and laboratory evaluation, he/she will be assigned into one of the groups listed below based on the degree of suspicion of an infectious process. Every effort will be made to have approximately one-third of the patients recruited from each of the following groups.
Group 1: Low pre-scan suspicion of infection. The incidence of infection based on past experience is <10% in this population.
Group 2: High pre-scan suspicion of infection. The incidence of infection in this group is quite high based on past experience.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients selected for entry into this study will be men or women of any ethnic background who are scheduled to undergo clinical and diagnostic evaluation by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania Health System or by the collaborating physicians at the Rothman Institute or the VA Philadelphia Medical Center.
- •Study I: FDG-PET imaging in painful partial or total joint prostheses Each patient who is a candidate will be evaluated by one of the collaborators mentioned above for a painful partial or total joint prosthesis. The patient will undergo an appropriate routine evaluation including history, physical examination, radiographic, scintigraphic, and necessary laboratory evaluation. An initial diagnosis must be made for each patient. The diagnosis of loosening will be established based on clinical examination and/or radiographic evaluation demonstrating clear evidence of this complication. Other etiologies for the joint pain, except for infection and aseptic loosening, need to be excluded. Surgical intervention (prosthesis revision) may or may not be planned for the patient who is a candidate for this study.
- •Study II: FDG-PET imaging following uncomplicated partial or total joint arthroplasty All patients fulfilling the criteria below will be considered potential candidates for this study. Each patient must have a diagnosis of degenerative joint disease caused by osteoarthritis (no previous hip surgery) and have undergone primary partial or total joint arthroplasty by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania or referring hospitals. Other causes of degenerative joint disease will be excluded by physical, radiographic and laboratory evaluation as clinically indicated. Osteoarthritis is the most common cause of degenerative joint disease, and in order to avoid any confounding factors in experimental results that may be caused by other types of disorders, only this group of patients will be studied. A patient will be eliminated from this group at anytime if the post-operative course is complicated by any process that is thought to influence the outcome. Variations from an uncomplicated postoperative course will be determined by the operating surgeon and include clinical signs or other evidence to suggest infection, early loosening, or any other process directly involving the prosthesis.
排除标准
- •Patients with other etiologies for pain, other than for infection and aseptic loosening, will be excluded from enrollment into the study.
结局指标
主要结局
SUV measurement from PET scan
时间窗: Assessed after FDG scan
Standardized Uptake Value
次要结局
未报告次要终点