Hip ArthroplastyNCT01017562
Differentiation of Aseptic From Septic Loosening by 18F-fluoride PET
An observational study of Hip Arthroplasty, run by Yokohama City University Medical Center at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Arthroplasty
- How many people
- 61 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients after total hip arthroplasty who agreed with the informed consent for this study.
Who may be able to join
None listed.
Who cannot join
- Within one year after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differentiation of Aseptic From Septic Loosening in Patients With Total Hip Arthroplasty Using 18F-fluoride PET
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.
- Conditions
- Hip Arthroplasty
- Keywords
- To clarify the 18F-fluoride uptake patterns associated with aseptic or septic loosening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| condition of joint implant | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startApr 2007
- Primary completionSep 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Naomi Kobayashi, MD, PhD., Principal investigator, Department of orthopaedic surgey, Yokohama City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017562
- Sponsor's protocol ID
- YCU21-106
- Status last verified
- Nov 2009
- First submitted
- 19 Nov 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation of Aseptic From Septic Loosening in Patients With Total Hip Arthroplasty Using 18F-fluoride PET
- ClinicalTrials.gov ID
- NCT01017562
- Acronym / sponsor ID
- YCU21-106
- Conditions
- Hip Arthroplasty
- Keywords
- To clarify the 18F-fluoride uptake patterns associated with aseptic or septic loosening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| condition of joint implant | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after total hip arthroplasty who agreed with the informed consent for this study.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Within one year after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Kobayashi, MD, PhD. principal investigator
Department of orthopaedic surgey, Yokohama City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthroplasty, run by Yokohama City University Medical Center at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.