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Completed

NCT Number: NCT04755140

Endoprosthesis Metal Toxicity Study

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.

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Key information

About this study

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

  • Sign the consent document.
  • 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.
  • Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has an endoprosthesis after extremity malignancy

Exclusion criteria

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

Treatment and study plan

Questionnaires

Behavioral

The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.

Interviews

Behavioral

Cognition and memory interviews will take place with the patient.

Blood test

Diagnostic Test

Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.

Echocardiogram

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2021
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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