Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty

NCT04166539 | Completed DMC

• 3 other identifiers: 19-001294R01AG060920R01HL147155
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metallosis; Pain; Total Hip Replacement; Total Knee Replacement

Keywords

Revision Surgery; Hip; Knee; Metals; Metallosis; Toxicity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Metallosis Patients

Patients who are being seen by surgeons for metal-related issues in the blood, pain, or revision surgery.

Behavioral: Questionnaires; Behavioral: Interviews; Other: Blood draw; Radiation: Magnetic Resonance Imaging; Diagnostic Test: Echocardiogram

Control Group

Patients who have had total hip or knee arthroplasty no less than 5-10 years ago, who have no symptoms.

Behavioral: Questionnaires; Behavioral: Interviews; Other: Blood draw; Radiation: Magnetic Resonance Imaging; Diagnostic Test: Echocardiogram

Interventions

Questionnaires BEHAVIORAL

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

Control Group; Metallosis Patients

Interviews BEHAVIORAL

Behavioral and Memory interviews will take place with the patient.

Control Group; Metallosis Patients

Blood draw OTHER

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

Control Group; Metallosis Patients

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.

Also known as: MRI

Control Group; Metallosis Patients

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.

Control Group; Metallosis Patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain

Interventions

Surveys and Questionnaires; Interviews as Topic; Blood Specimen Collection; Magnetic Resonance Spectroscopy; Echocardiography

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Hilal Maradit Kremers, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 18, 2019
• Study Start: October 1, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)