Hip Replacement ArthroplastyNCT01394744
Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement
An observational study of Hip Replacement Arthroplasty, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
Trial summary
The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Replacement Arthroplasty
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2011to 15 Feb 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: total of 30 subjects; 10 with metal-on-metal, 10 with ceramic-on-ceramic and 10 with ceramic-on-metal hip replacement;
Who may be able to join
- age over 18 years, necessity of hip replacement, informed consent
Who cannot join
- acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Ludwig-Maximilians-University Munich, Dept. of Dermatology
Munich, Bavaria, 80337
ARCUS Sportklinik
Pforzheim, 75179
About this study
Official title: Determination of Metal Ion Levels in the Serum and Assessment of the Respective Cytokine Production of Peripheral Blood Cells in Patients With a Hard-on-hard Bearing Total Hip Replacement
The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. The rationale is that a) the bearing wear releases particles respectively metal ions into the joint and the blood which will differ in quantity and composition; b) the cytokine production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the metal and the ceramic particles.
The patients from whom the respective samples will be analyzed are randomized in one of the following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm bearing is used in all patients. In this separate study, follow-up data of the clinical and radiographic examinations of the patients are available.
- Conditions
- Hip Replacement Arthroplasty
- Keywords
- metal, ion, cytokine, hip arthroplasty, blood, Assessment, cytokine profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Replacement 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- ARCUS-Sportklinik, DePuy Orthopaedics
- Responsible party
- Principal investigator, Peter Thomas, Ludwig-Maximilians - University of Munich
- Investigators
- Peter Thomas, Prof., Principal investigator, Ludwig-Maximilans-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394744
- Sponsor's protocol ID
- 10-1739 / IIS2009029
- Status last verified
- Feb 2019
- First submitted
- 13 Jul 2011
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Metal Ion Levels in the Serum and Assessment of the Respective Cytokine Production of Peripheral Blood Cells in Patients With a Hard-on-hard Bearing Total Hip Replacement
- ClinicalTrials.gov ID
- NCT01394744
- Acronym / sponsor ID
- 10-1739 / IIS2009029
- Conditions
- Hip Replacement Arthroplasty
- Keywords
- metal, ion, cytokine, hip arthroplasty, blood, Assessment, cytokine profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- ARCUS-Sportklinik, DePuy Orthopaedics
- Study start
- Aug 2011
- Primary completion
- Nov 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 14 Jul 2011 (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.
The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. The rationale is that a) the bearing wear releases particles respectively metal ions into the joint and the blood which will differ in quantity and composition; b) the cytokine production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the metal and the ceramic particles.
The patients from whom the respective samples will be analyzed are randomized in one of the following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm bearing is used in all patients. In this separate study, follow-up data of the clinical and radiographic examinations of the patients are available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- total of 30 subjects; 10 with metal-on-metal, 10 with ceramic-on-ceramic and 10 with ceramic-on-metal hip replacement;
Key inclusion criteria (1 listed)
- age over 18 years, necessity of hip replacement, informed consent
Key exclusion criteria (1 listed)
- acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years
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 27 Feb 2019.
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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.
Peter Thomas, Prof. principal investigator
Ludwig-Maximilans-University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Replacement Arthroplasty, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
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 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 27 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.