FDG-PET Imaging in Painful Joint Prosthesis

NCT00194285 | Active Not Recruiting

• 1 other identifier: R01AR048241-03
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Joint Prostheses

Keywords

Prosthesis; [18 F] Fluorodeoxyglucose; Positron Emission Tomography Imaging

Outcome Measures

Primary Outcomes (1)

• SUV measurement from PET scan

  Standardized Uptake Value

  Assessed after FDG scan

Interventions

FDG-PET Imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Five hundred 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 for joint prosthesis revision by members of the Department of Orthopedic Surgery at the University of Pennsylvania Health System (Hospital of University of Pennsylvania and Pennsylvania Hospital) or by the collaborating physicians at the Rothman Institute at Thomas Jefferson University Hospital or the VA Hospital.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Abass Alavi, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: March 1, 2001
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)