NCT04166539

Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty

Risk of Dementia and Heart Failure in Total Joint Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metallosis
• Pain
• Total Hip Replacement
• Total Knee Replacement

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-09-27
• Completion: 2021-09-27
• First posted: 2019-11-18
• Last updated: 2021-12-08

Locations

1 site across 1 country: United States