Endoprosthesis Metal Toxicity Study

December 12, 2024 updated by: Mayo Clinic

Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis

The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At your first visit you will be asked to do the following:

  1. Sign the consent document.
  2. Patient Interview: An interview will be conducted by the study coordinator on the research team. They will ask your past surgical history, health history, medications, and your cognition.
  3. Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
  4. Memory Interview: You will be evaluated on your memory and thinking skills three total times. One to determine baseline, and then repeated at one year and two years. You will answer questions that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
  5. Blood Draw: You will have a blood draw three times (4.2-5 tablespoons) to determine your baseline, 1 year, and 2 year research results.

6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

150 patients to complete cardiology part of the study (questionnaires, blood test, echocardiogram).

150 patients to complete cognitive part of the study (questionnaires, interviews, blood test).

Patient groups may overlap.

Description

Inclusion Criteria:

  • Patient has an endoprosthesis after extremity malignancy

Exclusion Criteria:

  • Current fracture or infection around the endoprosthesis
  • Patient is pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoprosthesis
Patients with a endoprosthesis
Behavioral: Questionnaires
The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.
Behavioral: Interviews
Cognition and memory interviews will take place with the patient.
Diagnostic test: Blood Test
Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.
Diagnostic test: Echocardiogram
Each echocardiogram takes about 3 hours and 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echo - Left Ventricular Ejection Fraction
Time Frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV ejection fraction as a percent.
Echo's will be taken at baseline, 1 year, and 2 years
Echo - Left Ventricular Mass
Time Frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV Mass in grams.
Echo's will be taken at baseline, 1 year, and 2 years
Echo - Heart Hypertrophy
Time Frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.
Echo's will be taken at baseline, 1 year, and 2 years
Cobalt Metal Levels
Time Frame: Cobalt level will be measured at baseline, 1 year, and 2 years
The change in cobalt blood ion levels will be measured in ng/mL.
Cobalt level will be measured at baseline, 1 year, and 2 years
Chromium Metal Levels
Time Frame: Chromium level will be measured at baseline, 1 year, and 2 years
The change in chromium blood ion levels will be measured in ng/mL.
Chromium level will be measured at baseline, 1 year, and 2 years
Titanium Metal Levels
Time Frame: Titanium level will be measured at baseline, 1 year, and 2 years
The change in titanium blood ion levels will be measured in ng/mL.
Titanium level will be measured at baseline, 1 year, and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometrist Testing - Intelligence Score
Time Frame: Testing will occur at baseline, 1 year, and 2 years.
The change in participants' intelligence will be measured using the Wechsler Adult Intelligence Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.
Testing will occur at baseline, 1 year, and 2 years.
Psychometrist Testing - Memory Score
Time Frame: Testing will occur at baseline, 1 year, and 2 years.
The change in participants' memory will be measured using the Wechsler Adult Memory Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.
Testing will occur at baseline, 1 year, and 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Matthew Houdek, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-008408
  • R01AG060920 (U.S. NIH Grant/Contract)
  • R01HL147155-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on Questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe