Hip ReplacementNCT00883805
Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty
An observational study of Hip Replacement and Hip Implant, run by Northwell Health at 1 site in United States.
Trial summary
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hip Replacement, Hip Implant, Total Hip Arthroplasty
- What is being tested?
- Blood draw and X-Ray of Hip
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects enrolled will have already undergone a total hip arthroplasty with either a metal-on-metal articulation, or a ceramic-on-metal articulation.
Who may be able to join
- Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery.
- Patient must be able to provide consent to participate
Who cannot join
- Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition
- Evidence of active infections
- Patients whose occupations include welding or metal working
- A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation
- unwillingness to comply with rehabilitation program or inability to return for follow-up visits
- Any systemic steroid therapy within 3 months of surgery
- Subjects who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.
Read the detailed description
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term analysis of implant survivability, and cancer rates in the two patient populations.
Increased metal ion production has been documented in metal-on-metal arthroplasty articulations. There are several concerns over metal ion production. First, even though there is a decreased histiocytic response to metallic debris, a dose dependent cytotoxic response with Interleukin 6, Prostaglandin E2, and Tumor Necrosis Factor alpha persists and may cause osteolysis in the long term. Second, increased levels of cobalt, chromium and nickel has been shown to correlate with increased cancer rates in several animal models, and the carcinogenic risk in humans has not been fully elucidated as yet. Third, hypersensitivity reactions to metal ion develop in up to 25% of these patients, and 60% of patients with poorly functioning hip.
Ceramic on metal avoids many of these problems due to the improved wear characteristics. If the level of metal ion production is significantly reduced and the implant survivability is proven in long term studies, this articulation may become the preferred method.
- Being tested
- Blood draw, X-Ray of Hip
- Keywords
- Metal Ion Concentration, Osteolysis
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawBiological
Subjects will give blood for analysis of metal ion concentrations
X-Ray of HipRadiation
Subject will have x-ray of hip to assessment of osteolysis
| Study group | Role | What they receive |
|---|---|---|
| Metal-on-Metal Articulations | Subjects will be people who have had metal-on-metal total hip arthroplasties Receives: Biological: Blood draw; Radiation: X-Ray of Hip | |
| Ceramic-on-Metal Articulations | Subjects will be people who have had ceramic-on-metal total hip arthroplasties Receives: Biological: Blood draw; Radiation: X-Ray of Hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
metal ion concentration in urine
Measured: 1 year post-op
Secondary outcomes (1)
metal ion concentration in blood
Measured: 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2014
Why it stopped: PI moved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Grande, Northwell Health
- Investigators
- Daniel Grande, Ph.D., Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883805
- Sponsor's protocol ID
- GCRC 0163
- Other IDs
- IRB# 07-08-105
- Status last verified
- Sep 2015
- First submitted
- 17 Apr 2009
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00883805
- Acronym / sponsor ID
- GCRC 0163
- Keywords
- Metal Ion Concentration, Osteolysis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI moved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2014 (actual)
- First posted
- 20 Apr 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.
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.
Detailed description
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term analysis of implant survivability, and cancer rates in the two patient populations.
Increased metal ion production has been documented in metal-on-metal arthroplasty articulations. There are several concerns over metal ion production. First, even though there is a decreased histiocytic response to metallic debris, a dose dependent cytotoxic response with Interleukin 6, Prostaglandin E2, and Tumor Necrosis Factor alpha persists and may cause osteolysis in the long term. Second, increased levels of cobalt, chromium and nickel has been shown to correlate with increased cancer rates in several animal models, and the carcinogenic risk in humans has not been fully elucidated as yet. Third, hypersensitivity reactions to metal ion develop in up to 25% of these patients, and 60% of patients with poorly functioning hip.
Ceramic on metal avoids many of these problems due to the improved wear characteristics. If the level of metal ion production is significantly reduced and the implant survivability is proven in long term studies, this articulation may become the preferred method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal-on-Metal Articulations | – | Biological: Blood draw, Radiation: X-Ray of HipSubjects will be people who have had metal-on-metal total hip arthroplasties |
| Ceramic-on-Metal Articulations | – | Biological: Blood draw, Radiation: X-Ray of HipSubjects will be people who have had ceramic-on-metal total hip arthroplasties |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects enrolled will have already undergone a total hip arthroplasty with either a metal-on-metal articulation, or a ceramic-on-metal articulation.
Key inclusion criteria (2 listed)
- Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery.
- Patient must be able to provide consent to participate
Key exclusion criteria (7 listed)
- Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition
- Evidence of active infections
- Patients whose occupations include welding or metal working
- A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation
- unwillingness to comply with rehabilitation program or inability to return for follow-up visits
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 |
|---|---|---|
| Blood drawSubjects will give blood for analysis of metal ion concentrations | Biological | Ceramic-on-Metal Articulations, Metal-on-Metal Articulations |
| X-Ray of HipSubject will have x-ray of hip to assessment of osteolysis | Radiation | Ceramic-on-Metal Articulations, Metal-on-Metal Articulations |
Primary outcome
metal ion concentration in urine
Time frame: 1 year post-op
1 secondary outcome
metal ion concentration in blood
Time frame: 1 year post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Daniel Grande, Ph.D. principal investigator
Feinstein Institute for Medical Research
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 Replacement and Hip Implant, run by Northwell Health 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 17 Sep 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 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 was withdrawn before enrolling participants, so there are no results.
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?
metal ion concentration in urine (time frame: 1 year post-op). 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 17 Sep 2015.