Clinical trial NCT04166539: Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
Official title: Risk of Dementia and Heart Failure in Total Joint Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metallosis
Pain
Total Hip Replacement
Total Knee Replacement
Keywords: Revision Surgery
Hip
Knee
Metals
Metallosis
Toxicity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-11-18
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Mild Cognitive Impairment
timeFrame: 1 year
measure: Brain MRI findings
timeFrame: 1 year
measure: Left ventricular dysfunction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Principal Investigator
name: Hilal Maradit Kremers, MD
role: PRINCIPAL_INVESTIGATOR
References: