Endoprosthesis Metal Toxicity Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
At your first visit you will be asked to do the following:
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Sign the consent document.
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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.
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Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
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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.
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Echo - Left Ventricular Ejection Fraction [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 - Left Ventricular Mass [Echo's will be taken at baseline, 1 year, and 2 years]
The echocardiogram will measure changes in LV Mass in grams.
- Echo - Heart Hypertrophy [Echo's will be taken at baseline, 1 year, and 2 years]
The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.
- Cobalt Metal Levels [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.
- Chromium Metal Levels [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.
- Titanium Metal Levels [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 Outcome Measures
- Psychometrist Testing - Intelligence Score [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.
- Psychometrist Testing - Memory Score [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient has an endoprosthesis after extremity malignancy
Exclusion Criteria:
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Current fracture or infection around the endoprosthesis
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Patient is pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Matthew Houdek, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20-008408
- R01AG060920
- R01HL147155-02