Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194285
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2005-09-13
Brief Title:
FDG-PET Imaging in Painful Joint Prosthesis
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
FDG-PET Imaging in Painful Joint Prosthesis Protocol Amendment Version 11 Dated 92005
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 heshe 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 heshe 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
Group 3 Intermediate pre-scan suspicion of infection Criteria Any patient who does not fit into either group 1 or 2 will be considered for this category The incidence of infection in this group based on past experience is intermediate
Considering the large number of patients who undergo joint revision more than 300 annually in the participating institutions combined we expect no difficulties in recruiting adequate numbers in all 3 categories
Each patient will undergo only one preoperative diagnostic FDG-PET scan After the PET scan is completed a diagnosis and detailed description of the observations made will be communicated to the attending surgeon before the operation We believe this information will enable investigators to establish the correct diagnosis during surgical intervention
Study II FDG-PET imaging following uncomplicated partial or total joint arthroplasty To accomplish this goal we will enroll 10 patients per year for the first 3 years FDG-PET scans will be performed at approximately 12 months 18 months andor 2 years following surgery All scans will occur within 2 months of the 12- 18- andor 24-month anniversary of that patients most recent joint replacement surgery It is unknown how long FDG uptake persists in an uncomplicated partial or total joint arthroplasty The expected pattern of FDG uptake following arthroplasty will provide a basis for the correct diagnosis of periprosthetic infection and loosening during the life of the implant
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 heshe 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 heshe 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
Group 3 Intermediate pre-scan suspicion of infection Criteria Any patient who does not fit into either group 1 or 2 will be considered for this category The incidence of infection in this group based on past experience is intermediate
Considering the large number of patients who undergo joint revision more than 300 annually in the participating institutions combined we expect no difficulties in recruiting adequate numbers in all 3 categories
Each patient will undergo only one preoperative diagnostic FDG-PET scan After the PET scan is completed a diagnosis and detailed description of the observations made will be communicated to the attending surgeon before the operation We believe this information will enable investigators to establish the correct diagnosis during surgical intervention
Study II FDG-PET imaging following uncomplicated partial or total joint arthroplasty To accomplish this goal we will enroll 10 patients per year for the first 3 years FDG-PET scans will be performed at approximately 12 months 18 months andor 2 years following surgery All scans will occur within 2 months of the 12- 18- andor 24-month anniversary of that patients most recent joint replacement surgery It is unknown how long FDG uptake persists in an uncomplicated partial or total joint arthroplasty The expected pattern of FDG uptake following arthroplasty will provide a basis for the correct diagnosis of periprosthetic infection and loosening during the life of the implant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None