Endoprosthesis Metal Toxicity Study

Completed

• Conditions: Heart Diseases; Memory Problem; Cognitive Impairment; Cognitive Decline; Cancer of Bone; Chemotherapy Effect; Bone Tumor
• Interventions: Behavioral: Questionnaires; Behavioral: Interviews; Diagnostic Test: Blood Test; Diagnostic Test: Echocardiogram

• Registration Number: NCT04755140
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-15
• Study Start: 2021-03-19
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient has an endoprosthesis after extremity malignancy

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoprosthesis	Echocardiogram	Patients with a endoprosthesis
Endoprosthesis	Blood Test	Patients with a endoprosthesis
Endoprosthesis	Questionnaires	Patients with a endoprosthesis
Endoprosthesis	Interviews	Patients with a endoprosthesis

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States