OsteoarthritisNCT00156598
Metal Ion Serum Concentrations in Patients With Total Hip Replacements
An observational study of Osteoarthritis, run by The University of Texas Health Science Center at San Antonio.
Trial summary
Other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. We want to learn whether these elevated levels are associated with any adverse effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to May 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Local surgeon's patients who have had a hip implant.
Who may be able to join
- Group 1 - unilateral hip replacement with metal on metal prosthesis, well functioning.
- Group 2 - loosening of plastic and metal prosthesis Group 3 - osteoarthritis of the hip and awaiting total hip replacement
Who cannot join
- renal dysfunction
- other types of metal implants or dental prostheses
- rheumatoid arthritis
- hip infection
About this study
Official title: Cobalt, Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs. Metal on Polyethylene Total Hip Replacements
Other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. We want to learn whether these elevated levels are associated with any adverse effects. We hope this study will help us identify which type of patients have elevated levels of metal in their blood.
Read the detailed description
It is suspected that the concentration of the metals chromium, cobalt and titanium in the blood will be higher in people with an all metal total hip prosthesis than in those with a plastic and metal prosthesis. To find out if this is true, we will test blood samples for the levels of metal in the blood and compare the values from 3 groups of people:
- people with metal on metal hip replacements
- loosening of a plastic and metal prosthesis and
- evidence of osteoarthritis and are awaiting a total hip replacement.
- Conditions
- Osteoarthritis
- Keywords
- metal ion concentration
- Medical subject headings
- Osteoarthritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Resident graduated; faculty mentor retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Lorence Trick, MD, Principal investigator, University of Texas Health Science Center Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156598
- Sponsor's protocol ID
- 045-0031-006
- Status last verified
- Jun 2012
- First submitted
- 7 Sep 2005
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cobalt, Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs. Metal on Polyethylene Total Hip Replacements
- ClinicalTrials.gov ID
- NCT00156598
- Acronym / sponsor ID
- 045-0031-006
- Conditions
- Osteoarthritis
- Keywords
- metal ion concentration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Resident graduated; faculty mentor retired
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Aug 2004
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Sep 2005 (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.
Other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. We want to learn whether these elevated levels are associated with any adverse effects. We hope this study will help us identify which type of patients have elevated levels of metal in their blood.
Detailed description
It is suspected that the concentration of the metals chromium, cobalt and titanium in the blood will be higher in people with an all metal total hip prosthesis than in those with a plastic and metal prosthesis. To find out if this is true, we will test blood samples for the levels of metal in the blood and compare the values from 3 groups of people:
- people with metal on metal hip replacements
- loosening of a plastic and metal prosthesis and
- evidence of osteoarthritis and are awaiting a total hip replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Local surgeon's patients who have had a hip implant.
Key inclusion criteria (2 listed)
- Group 1 - unilateral hip replacement with metal on metal prosthesis, well functioning.
- Group 2 - loosening of plastic and metal prosthesis Group 3 - osteoarthritis of the hip and awaiting total hip replacement
Key exclusion criteria (4 listed)
- renal dysfunction
- other types of metal implants or dental prostheses
- rheumatoid arthritis
- hip infection
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 was stopped early (reason given: Resident graduated; faculty mentor retired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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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.
Lorence Trick, MD principal investigator
University of Texas Health Science Center Department of Orthopaedics
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by The University of Texas Health Science Center at San Antonio.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Resident graduated; faculty mentor retired). Results are not available in the source record.
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 2 Jul 2012.