Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty

Pain Clinical Trial

Official title:

Risk of Dementia and Heart Failure in Total Joint Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166539
• Other study ID #: 19-001294
• Secondary ID: R01AG060920R01HL
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: December 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mild Cognitive Impairment	Cognitive impairment as assessed through interviews	1 year
Primary	Brain MRI findings	imaging	1 year
Primary	Left ventricular dysfunction	heart dysfunction as assessed using echocardiography	1 year

External Links

•   Mayo Clinic Clinical Trials