HealthyNCT00714610
Serum Metal Ion Concentrations Following Primary Hip Arthroplasty
An observational study of Healthy, run by University of Utah at 1 site in United States.
Trial summary
The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty. It is unknown if the presence of bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs) leads to higher serum metal ion concentrations… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2013
- 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: Two groups were identified: the first group having undergone unilateral large-head (≥38 mm) primary MOM THA and the second having undergone bilateral large-head primary MOM THA. Patients were at least 18 years old, were at least 1 year out from their index procedure, and had well-positioned components. Patients in both cohorts had cementless modular titanium alloy proximally porous-coated, tapered femoral stems (Biomet Taperloc or Bi-Metric; Biomet, Warsaw, Ind). All surgeries were done between the years of 2003 and 2009.
Who may be able to join
- undergone unilateral large-head (≥38 mm) primary MOM THA
- undergone bilateral large-head primary MOM THA
- 18 years old or older
- at least one year out from their index procedure
- had well-positioned components
Who cannot join
- other metal implants
- renal insufficiency (estimated creatinine clearance b30 mL/min)
- component malpositioning (cup inclination angle N55°)
- evidence of osteolysis on radiographs
- a poorly functioning hip (Harris Hip Score [HHS] b70)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Serum Metal Ion Concentrations Following Unilateral Versus Bilateral Large Head Metal on Metal Primary Hip Arthroplasty
The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty. It is unknown if the presence of bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs) leads to higher serum metal ion concentrations than unilateral MOM THA. Elevated levels (chromium, 17 μg/L; cobalt, 19 μg/L) have been associated with poorly functioning MOM THA with metallosis. Fourteen patients having undergone bilateral and 25 patients having undergone unilateral large-head primary MOM THA were compared. Harris Hip Scores, University of California Los Angeles activity scores, radiographs, serum creatinine, and serum cobalt and chromium levels were obtained.
Read the detailed description
The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty.
The effect of the presence of bilateral large-head MOM THA on circulating metal ions levels has not been thoroughly studied. Metal ion levels in patients with unilateral MOM vs bilateral MOM resurfacing and small-head THA have been reported; however, to the investigators knowledge, no study has investigated the differences in serum metal ion levels in unilateral vs bilateral largehead (≥38 mm) MOM THA. The objective of this study was to compare serum cobalt and chromium levels in patients who have undergone unilateral vs bilateral large-head MOM THA to better understand the effect of the presence of bilateral implants on circulating metal ion levels. The investigators believe that further understanding baseline levels in well-functioning MOM THA will increase the clinical utility of checking serum metal ion levels in the workup of the painful MOM THA. The investigators hypothesis was that serum metal ion levels in patients with well-functioning bilateral large-head MOM THA would be higher than levels in patients with well functioning unilateral large-head MOM THA, but these levels would not approach those seen with metallosis.
- Conditions
- Healthy
- Keywords
- Serum metal ion concentration
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 |
|---|---|---|
| 1 | Unilateral or bilateral large head metal on metal primary total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Metal Ion Concentrations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Peters, University of Utah
- Investigators
- Christopher Peters, MD, Principal investigator, University of Utah Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714610
- Sponsor's protocol ID
- 21498
- Status last verified
- Feb 2014
- First submitted
- 8 Jul 2008
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Metal Ion Concentrations Following Unilateral Versus Bilateral Large Head Metal on Metal Primary Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00714610
- Acronym / sponsor ID
- 21498
- Conditions
- Healthy
- Keywords
- Serum metal ion concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jul 2008 (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 objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty. It is unknown if the presence of bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs) leads to higher serum metal ion concentrations than unilateral MOM THA. Elevated levels (chromium, 17 μg/L; cobalt, 19 μg/L) have been associated with poorly functioning MOM THA with metallosis. Fourteen patients having undergone bilateral and 25 patients having undergone unilateral large-head primary MOM THA were compared. Harris Hip Scores, University of California Los Angeles activity scores, radiographs, serum creatinine, and serum cobalt and chromium levels were obtained.
Detailed description
The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty.
The effect of the presence of bilateral large-head MOM THA on circulating metal ions levels has not been thoroughly studied. Metal ion levels in patients with unilateral MOM vs bilateral MOM resurfacing and small-head THA have been reported; however, to the investigators knowledge, no study has investigated the differences in serum metal ion levels in unilateral vs bilateral largehead (≥38 mm) MOM THA. The objective of this study was to compare serum cobalt and chromium levels in patients who have undergone unilateral vs bilateral large-head MOM THA to better understand the effect of the presence of bilateral implants on circulating metal ion levels. The investigators believe that further understanding baseline levels in well-functioning MOM THA will increase the clinical utility of checking serum metal ion levels in the workup of the painful MOM THA. The investigators hypothesis was that serum metal ion levels in patients with well-functioning bilateral large-head MOM THA would be higher than levels in patients with well functioning unilateral large-head MOM THA, but these levels would not approach those seen with metallosis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Unilateral or bilateral large head metal on metal primary total hip arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups were identified: the first group having undergone unilateral large-head (≥38 mm) primary MOM THA and the second having undergone bilateral large-head primary MOM THA. Patients were at least 18 years old, were at least 1 year out from their index procedure, and had well-positioned components. Patients in both cohorts had cementless modular titanium alloy proximally porous-coated, tapered femoral stems (Biomet Taperloc or Bi-Metric; Biomet, Warsaw, Ind). All surgeries were done between the years of 2003 and 2009.
Key inclusion criteria (5 listed)
- undergone unilateral large-head (≥38 mm) primary MOM THA
- undergone bilateral large-head primary MOM THA
- 18 years old or older
- at least one year out from their index procedure
- had well-positioned components
Key exclusion criteria (5 listed)
- other metal implants
- renal insufficiency (estimated creatinine clearance b30 mL/min)
- component malpositioning (cup inclination angle N55°)
- evidence of osteolysis on radiographs
- a poorly functioning hip (Harris Hip Score [HHS] b70)
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
Serum Metal Ion Concentrations
Time frame: 1 year
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 4 Feb 2014.
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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.
Christopher Peters, MD principal investigator
University of Utah Orthopaedic Center
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 Healthy, run by University of Utah at 1 site in United States.
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 5 inclusion and 5 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 4 Feb 2014. 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 United States. 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.
What does the primary outcome measure?
Serum Metal Ion Concentrations (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 4 Feb 2014.