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Completed

NCT Number: NCT04166539

Neurotoxicity and Cardiotoxicity 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.

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Key information

Conditions

Metallosis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Total Hip Replacement Total Knee Replacement

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Behavioral

You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.

Interviews

Behavioral

Behavioral and Memory interviews will take place with the patient.

Blood Draw

Other

Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.

Magnetic resonance imaging

Radiation

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

Echocardiogram

Diagnostic 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.

Primary outcomes

  1. Mild Cognitive Impairment

    Time frame: 1 year

    Cognitive impairment as assessed through interviews

  2. Brain MRI findings

    Time frame: 1 year

    imaging

  3. Left ventricular dysfunction

    Time frame: 1 year

    heart dysfunction as assessed using echocardiography

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute on Aging (NIA)

Registry information

Official study title

Risk of Dementia and Heart Failure in Total Joint Arthroplasty

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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