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Differentiation of Aseptic From Septic Loosening by 18F-fluoride PET

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ClinicalTrials.gov Identifier: NCT01017562
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
In this study, the investigators utilized the 18F-fluoride PET method to evaluate THA cases with a stable, septic or septic loosened implant in order to differentiate these clinical settings using a novel uptake type classification approach.

Condition or disease
Hip Arthroplasty

Study Design

Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Differentiation of Aseptic From Septic Loosening in Patients With Total Hip Arthroplasty Using 18F-fluoride PET
Study Start Date : April 2007
Primary Completion Date : September 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
condition of joint implant


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after total hip arthroplasty who agreed with the informed consent for this study.
Criteria

Exclusion Criteria:

  • Within one year after surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017562


Locations
Japan
Departement of orthopaedic sugery
Yokohama, Kanagawa, Japan, 236-0004
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
Principal Investigator: Naomi Kobayashi, MD, PhD. Department of orthopaedic surgey, Yokohama City University
More Information

ClinicalTrials.gov Identifier: NCT01017562     History of Changes
Other Study ID Numbers: YCU21-106
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009

Keywords provided by Yokohama City University Medical Center:
To clarify the 18F-fluoride uptake patterns associated with aseptic or septic loosening

Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs