Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Pain; Total Hip Replacement; Metallosis; Total Knee Replacement
• Intervention / Treatment: Behavioral: Questionnaires; Behavioral: Interviews; Other: Blood draw; Radiation: Magnetic Resonance Imaging; Diagnostic test: Echocardiogram

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 Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metallosis Patients; Patients who are being seen by surgeons for metal-related issues in the blood, pain, or revision surgery.	Behavioral: Questionnaires; You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.; Behavioral: Interviews; Behavioral and Memory interviews will take place with the patient.; Other: Blood draw; Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.; Radiation: Magnetic Resonance Imaging; 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.; Other Names: MRI; Diagnostic test: Echocardiogram; 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.
Control Group; Patients who have had total hip or knee arthroplasty no less than 5-10 years ago, who have no symptoms.	Behavioral: Questionnaires; You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.; Behavioral: Interviews; Behavioral and Memory interviews will take place with the patient.; Other: Blood draw; Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.; Radiation: Magnetic Resonance Imaging; 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.; Other Names: MRI; Diagnostic test: Echocardiogram; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mild Cognitive Impairment	Cognitive impairment as assessed through interviews	1 year
Brain MRI findings	imaging	1 year
Left ventricular dysfunction	heart dysfunction as assessed using echocardiography	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Hilal Maradit Kremers, MD, Principal Investigator

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Knee; Toxicity; Hip; Revision Surgery; Metals; Metallosis
• Other Study ID Numbers: 19-001294; R01AG060920 (U.S. NIH Grant/Contract); R01HL147155 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No