Endoprosthesis Metal Toxicity Study

Study Overview
=================
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: 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.

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

Conditions
-----------------
Bone Tumor, Cancer of Bone, Heart Diseases, Cognitive Impairment, Cognitive Decline, Chemotherapy Effect, Memory Problem

Intervention / Treatment
-----------------
* Behavioral: Questionnaires
* Behavioral: Interviews
* Diagnostic Test: Blood Test
* Diagnostic Test: Echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has an endoprosthesis after extremity malignancy Exclusion Criteria: Current fracture or infection around the endoprosthesis Patient is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoprosthesis<br>Patients with a endoprosthesis | Behavioral: Questionnaires<br>* The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.<br>Behavioral: Interviews<br>* Cognition and memory interviews will take place with the patient.<br>Diagnostic Test: Blood Test<br>* Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.<br>Diagnostic Test: Echocardiogram<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echo - Left Ventricular Ejection Fraction | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoprosthesis, Metallosis, Toxicity