FDG-PET Imaging in Painful Joint Prosthesis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00194285
• Date of registration: 13/09/2005
• Primary sponsor: University of Pennsylvania
• Public title: FDG-PET Imaging in Painful Joint Prosthesis
• Scientific title: FDG-PET Imaging in Painful Joint Prosthesis (Protocol Amendment, Version 11, Dated 9/2005)
• Date of first enrolment: March 2001
• Target sample size: 530
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00194285
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Timothy J Chryssikos, BA

• Name: Timothy J Chryssikos, BA

• Name: Abass Alavi, MD
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- Patients with other etiologies for pain, other than for infection and aseptic
loosening, will be excluded from enrollment into the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Painful Joint Prostheses

Intervention(s)

Procedure: FDG-PET Imaging

Secondary ID(s)

RO1-AR048241-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)