Total Hip ReplacementNCT02049892
A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements
An observational study of Total Hip Replacement, run by Mayo Clinic at 1 site in United States.
Trial summary
Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Metal Ion Levels
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2013to 1 Feb 2016
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopedic patients with prior hip replacement.
Who may be able to join
- One total hip replacement, either a large metal head (>40) or a small metal head (<30) on a polyethylene bearing surface.
- 2 to 5 years s/p surgery minimum. No symptoms
Who cannot join
- Any other bearing surface besides metal on poly, no other joint replacements, symptomatic
Trial locations and contacts
1 site in 1 country.
About this study
Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.
- Conditions
- Total Hip Replacement
- Being tested
- Metal Ion Levels
- Keywords
- Total Hip Replacement, Metal Ion, 2-5 years after surgery, Asymptomatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal Ion LevelsOther
| Study group | Role | What they receive |
|---|---|---|
| Metal Ion | Not described Receives: Other: Metal Ion Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metal Ion levels
We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start1 Dec 2013
- Primary completion1 Jan 2016
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert T. Trousdale, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049892
- Sponsor's protocol ID
- 13-002050
- Status last verified
- Dec 2017
- First submitted
- 22 Jan 2014
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements
- ClinicalTrials.gov ID
- NCT02049892
- Acronym / sponsor ID
- 13-002050
- Conditions
- Total Hip Replacement
- Keywords
- Total Hip Replacement, Metal Ion, 2-5 years after surgery, Asymptomatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2013
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 30 Jan 2014 (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.
Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metal Ion | – | Other: Metal Ion Levels |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic patients with prior hip replacement.
Key inclusion criteria (2 listed)
- One total hip replacement, either a large metal head (>40) or a small metal head (<30) on a polyethylene bearing surface.
- 2 to 5 years s/p surgery minimum. No symptoms
Key exclusion criteria (1 listed)
- Any other bearing surface besides metal on poly, no other joint replacements, symptomatic
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 |
|---|---|---|
| Metal Ion Levels | Other | Metal Ion |
Primary outcome
Metal Ion levels
Time frame: 2 years
We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement
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 5 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Total Hip Replacement, run by Mayo Clinic 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 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 5 Dec 2017. 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?
Metal Ion levels (time frame: 2 years). 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 5 Dec 2017.