Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty

Mayo Clinic

Status

Completed

Conditions

Metallosis

Total Hip Replacement

Pain

Total Knee Replacement

Treatments

Diagnostic Test: Echocardiogram

Radiation: Magnetic Resonance Imaging

Behavioral: Interviews

Behavioral: Questionnaires

Other: Blood draw

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04166539

19-001294

R01AG060920 (U.S. NIH Grant/Contract)

R01HL147155 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient is willing to sign consent
Patients scheduled for revision surgery for osteolysis, aseptic loosening, or wear of TJA implants/ALTR.

-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