Hip RevisionPhase 4NCT00289679
Cytokine Profile and Metal Ion Concentrations at Patients Undergoing a Revision THR
A Phase 4 study testing Hip prosthesis revision in people with Hip Revision, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
To evaluate the concentration of cytokines and metal ions in blod samples and biopsies from patients undergoing a hip revision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Revision
- What is being tested?
- Hip prosthesis revision
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- THR revision
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Frederiksberg University Hospital
Frederiksberg, Frederiksberg, 2000
arne borgwardt, md, 004538163450, arne@borgwardt.com
About this study
To evaluate the concentration of cytokines and metal ions in blod samples and biopsies from patients undergoing a hip revision.
- Conditions
- Hip Revision
- Being tested
- Hip prosthesis revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip prosthesis revisionDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip RevisionStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- arne borgwardt, md, Principal investigator, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289679
- Sponsor's protocol ID
- kf 01059/04
- Status last verified
- Jul 2007
- First submitted
- 9 Feb 2006
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Profile and Metal Ion Concentrations at Patients Undergoing a Revision THR
- ClinicalTrials.gov ID
- NCT00289679
- Acronym / sponsor ID
- kf 01059/04
- Conditions
- Hip Revision
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- First posted
- 10 Feb 2006 (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.
To evaluate the concentration of cytokines and metal ions in blod samples and biopsies from patients undergoing a hip revision.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- THR revision
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip prosthesis revision | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
arne borgwardt, md principal investigator
Frederiksberg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hip prosthesis revision in people with Hip Revision, run by Frederiksberg University Hospital at 1 site in Denmark.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact arne borgwardt, md (004538163450, arne@borgwardt.com), or a site near the patient. 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 18 Mar 2015.