MetallosisNCT04166539
Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
An observational study of Metallosis and Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to understand whether patients who previously had total hip or total knee replacement experience memory, thinking or heart problems. This study will help us determine if and how often these problems occur. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Metallosis, Pain, Total Hip Replacement
- What is being tested?
- Questionnaires, Interviews and Blood draw
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 27 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 patients to complete cardiology part of the study (questionnaires, blood test, echocardiogram). 100 patients to complete cognitive part of the study (questionnaires, interviews, blood test, MRI). Patient groups may overlap.
Who may be able to join
- Patient is willing to sign consent
- Patients scheduled for revision surgery for osteolysis, aseptic loosening, or wear of TJA implants/ALTR.
- OR
- -MCSA (Mayo Clinic Study of Aging) patients with THA or TKA with at least 10 years since surgery.
Who cannot join
- History of dementia
- History of cardiomyopathy or heart failure
- Revision for infection or fracture
- Patient is pregnant
- Patient has medication patches on
- Patient has a pacemaker or defibrillator (ICD)
Show all 17Show fewer
- Patient has a deep brain stimulator (DBS)
- Patient has a vagal neuro stimulator (VNS)
- Patient has any other kind of neuro stimulator
- Patient has aneurysm clips in their head
- Patient has a tissue expander
- Patient has had a gastrointestinal clip or pill camera inserted in the last 90 days
- Patient has an esophageal reflux management system (LINX)
- Patient has a cochlear (ear) or auditory implant
- Patient has any implanted device (electronic or not) with magnets
- Patient has an eye injury involving metal
- Patient has allergy to contrast or dye
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Risk of Dementia and Heart Failure in Total Joint Arthroplasty
The purpose of this research is to understand whether patients who previously had total hip or total knee replacement experience memory, thinking or heart problems. This study will help us determine if and how often these problems occur.
Read the detailed description
At your first visit you will be asked to do the following.
- Sign this informed consent document.
- Questionnaire: You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.
- Interview: The interview will be performed by the study coordinator who is a member of the research team. It will take about 20-30 minutes to complete. You will be asked to answer questions about your general health, surgeries, medications, and your memory and thinking skills.
- Memory Interview: You will have an evaluation of your memory and thinking skills. You will answer questions and perform tasks that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
- Blood draw: Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.
- Magnetic Resonance Imaging (MRI) of your brain (optional): If you agree to participate, you will be asked to have MR imaging of your brain.
- Echocardiogram: You will be asked to have an echocardiogram of your heart.
- Follow-up visit in 2-3 years: You will be asked to return to Mayo for your second study visit in 2-3 years. At this visit, you will be asked to complete the same memory and thinking tests described for the first visit. You will also be asked to repeat the echocardiogram.
- Conditions
- Metallosis, Pain, Total Hip Replacement, Total Knee Replacement
- Being tested
- Questionnaires, Interviews, Blood draw, Magnetic Resonance Imaging, Echocardiogram
- Keywords
- Revision Surgery, Hip, Knee, Metals, Metallosis, Toxicity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.
InterviewsBehavioural
Behavioral and Memory interviews will take place with the patient.
Blood drawOther
Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.
Magnetic Resonance ImagingRadiation
Also called MRI
Each MR examination takes about 45 minutes and does not require the use of needles, medication or contrast enhancement. You will lie on your back and enter the MR scanner for the study, during which time you will hear knocking noises. People with pacemakers, aneurysm clips, cochlear implants, or metal/foreign objects in their eyes are not permitted to undergo MR studies. We will review your implants and determine your eligibility.
EchocardiogramDiagnostic test
Each echocardiogram takes about 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images.
| Study group | Role | What they receive |
|---|---|---|
| Metallosis Patients | Patients who are being seen by surgeons for metal-related issues in the blood, pain, or revision surgery. Receives: Behavioral: Questionnaires; Behavioral: Interviews; Other: Blood draw; Radiation: Magnetic Resonance Imaging; Diagnostic Test: Echocardiogram | |
| Control Group | Patients who have had total hip or knee arthroplasty no less than 5-10 years ago, who have no symptoms. Receives: Behavioral: Questionnaires; Behavioral: Interviews; Other: Blood draw; Radiation: Magnetic Resonance Imaging; Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mild Cognitive Impairment
Cognitive impairment as assessed through interviews
Measured: 1 year
Brain MRI findings
imaging
Measured: 1 year
Left ventricular dysfunction
heart dysfunction as assessed using echocardiography
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 posted18 Nov 2019
- Study start1 Oct 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetallosisStudies 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
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Hilal Maradit Kremers, Mayo Clinic
- Investigators
- Hilal Maradit Kremers, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166539
- Sponsor's protocol ID
- 19-001294
- Other IDs
- R01AG060920, R01HL147155
- Status last verified
- Dec 2021
- First submitted
- 7 Nov 2019
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Dementia and Heart Failure in Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT04166539
- Acronym / sponsor ID
- 19-001294
- Conditions
- Metallosis, Pain, Total Hip Replacement, Total Knee Replacement
- Keywords
- Revision Surgery, Hip, Knee, Metals, Metallosis, Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 18 Nov 2019 (actual)
- 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 purpose of this research is to understand whether patients who previously had total hip or total knee replacement experience memory, thinking or heart problems. This study will help us determine if and how often these problems occur.
Detailed description
At your first visit you will be asked to do the following.
- Sign this informed consent document.
- Questionnaire: You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.
- Interview: The interview will be performed by the study coordinator who is a member of the research team. It will take about 20-30 minutes to complete. You will be asked to answer questions about your general health, surgeries, medications, and your memory and thinking skills.
- Memory Interview: You will have an evaluation of your memory and thinking skills. You will answer questions and perform tasks that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
- Blood draw: Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.
- Magnetic Resonance Imaging (MRI) of your brain (optional): If you agree to participate, you will be asked to have MR imaging of your brain.
- Echocardiogram: You will be asked to have an echocardiogram of your heart.
- Follow-up visit in 2-3 years: You will be asked to return to Mayo for your second study visit in 2-3 years. At this visit, you will be asked to complete the same memory and thinking tests described for the first visit. You will also be asked to repeat the echocardiogram.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metallosis Patients | – | Behavioral: Questionnaires, Behavioral: Interviews, Other: Blood draw, Radiation: Magnetic Resonance Imaging, Diagnostic Test: EchocardiogramPatients who are being seen by surgeons for metal-related issues in the blood, pain, or revision surgery. |
| Control Group | – | Behavioral: Questionnaires, Behavioral: Interviews, Other: Blood draw, Radiation: Magnetic Resonance Imaging, Diagnostic Test: EchocardiogramPatients who have had total hip or knee arthroplasty no less than 5-10 years ago, who have no symptoms. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients to complete cardiology part of the study (questionnaires, blood test, echocardiogram). 100 patients to complete cognitive part of the study (questionnaires, interviews, blood test, MRI). Patient groups may overlap.
Key inclusion criteria (4 listed)
- Patient is willing to sign consent
- Patients scheduled for revision surgery for osteolysis, aseptic loosening, or wear of TJA implants/ALTR.
- OR
- -MCSA (Mayo Clinic Study of Aging) patients with THA or TKA with at least 10 years since surgery.
Key exclusion criteria (17 listed)
- History of dementia
- History of cardiomyopathy or heart failure
- Revision for infection or fracture
- Patient is pregnant
- Patient has medication patches on
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 |
|---|---|---|
| QuestionnairesYou will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities. | Behavioural | Control Group, Metallosis Patients |
| InterviewsBehavioral and Memory interviews will take place with the patient. | Behavioural | Control Group, Metallosis Patients |
| Blood drawHave a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests. | Other | Control Group, Metallosis Patients |
| Magnetic Resonance ImagingAlso: MRIEach MR examination takes about 45 minutes and does not require the use of needles, medication or contrast enhancement. You will lie on your back and enter the MR scanner for the study, during which time you will hear knocking noises. People with pacemakers, aneurysm clips, cochlear implants, or metal/foreign objects in their eyes are not permitted to undergo MR studies. We will review your implants and determine your eligibility. | Radiation | Control Group, Metallosis Patients |
| EchocardiogramEach echocardiogram takes about 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images. | Diagnostic test | Control Group, Metallosis Patients |
Primary outcome
Mild Cognitive Impairment
Time frame: 1 year
Cognitive impairment as assessed through interviews
Brain MRI findings
Time frame: 1 year
imaging
Left ventricular dysfunction
Time frame: 1 year
heart dysfunction as assessed using echocardiography
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 8 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Metallosis
Enrolling by invitationObservational study
Metallosis on Tissues and Serum Metal Levels in Children
Orthopedic Disorder, Retained Metal Implant
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.
Hilal Maradit Kremers, MD principal investigator
Principal Investigator
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 Metallosis and Pain, 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 4 inclusion and 17 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 8 Dec 2021. 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?
Mild Cognitive Impairment (time frame: 1 year). The study lists 3 primary outcomes in all. 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 8 Dec 2021.