NCT01017562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

2.4 years

First QC Date

November 19, 2009

Last Update Submit

November 19, 2009

Conditions

Hip Arthroplasty

Keywords

To clarify the 18F-fluoride uptake patterns associated with aseptic or septic loosening

Study Arms (1)

condition of joint implant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after total hip arthroplasty who agreed with the informed consent for this study.

You may not qualify if:

  • Within one year after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of orthopaedic sugery

Yokohama, Kanagawa, 236-0004, Japan

Location

Study Officials

  • Naomi Kobayashi, MD, PhD.

    Department of orthopaedic surgey, Yokohama City University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

April 1, 2007

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations

JP(1)