Status:
ACTIVE_NOT_RECRUITING
FDG-PET Imaging in Painful Joint Prosthesis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Painful Joint Prostheses
Eligibility:
All Genders
18+ years
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 complica...
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 cr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with other etiologies for pain, other than for infection and aseptic loosening, will be excluded from enrollment into the study.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT00194285
Start Date
March 1 2001
End Date
February 1 2026
Last Update
March 20 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104