NCT00194285

Active Not Recruiting

FDG-PET Imaging in Painful Joint Prosthesis

University of Pennsylvania Source

Other study identifiers

Sponsor study identifier

R01AR048241-03

NIH

Study Type

observational

Estimated enrollment

530

Locations

1 country

Sites

1

Timeline

Study Start

March 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

February 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 530 participants
Study completion date: February 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2001
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 19, 2005
Actual (reported)
Primary Completion
February 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: March 12, 2026
Status Verified: March 2026
Last Update Submitted: March 9, 2026

Conditions

Painful Joint Prostheses

Keywords

Prosthesis[18 F] FluorodeoxyglucosePositron Emission Tomography Imaging

Outcome Measures

Primary Outcomes (1)

SUV measurement from PET scan
Standardized Uptake Value
Assessed after FDG scan

Interventions

FDG-PET ImagingProcedure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

National Institutes of Health (NIH)
NIHcollaborator
University of Pennsylvania
Otherlead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

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 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2027

Estimated

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.

Contact the study team to confirm eligibility.

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

February 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

March 12, 2026

Record last verified: 2026-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00194285
Data provider: ClinicalTrials.gov
Source updated: 2026-03-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:01 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations