Clinical Trial: FDG-PET Imaging in Painful Joint Prosthesis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: FDG-PET Imaging in Painful Joint Prosthesis (Protocol Amendment, Version 11, Dated 9/2005)

Brief Summary: 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.

Detailed Summary:

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.