Ischemia Modified Albumin (IMA) Expression in the Male and Female Population

Study Overview
=================
Brief Summary
-----------------
The study has as general objective to analyze in the adult population, (male and female) the presence of a very common protein, in its normal form and modified, isolated from the blood of patients and called albumin. The opportunity to observe the distribution of this protein in the population, provides the basis to be able to perform this type of assay also in the population of patients with pathologies, in the near future, with the aim of increasing knowledge on the subjective tolerability to orthopedic implants.

Detailed Description
-----------------
100 patients, waiting for elective surgical intervention (such as hip replacement or primary knee ligament reconstruction, arthroscopy), distributed evenly by gender and age (50 men, 50 women including 25 postmenopausal and 25 in bearing age) and afferent to the Department of Surgery Prosthetic hip and knee of our Institute, will be enrolled. At execution time of blood sampling routine, a further specimen of whole blood (7 ml) will be added which will be sent to the Medical technology laboratory for IMA dosage. In addition, total albumin, ferritin, transferrin and serum iron will be analyzed from clinical pathological laboratory. The investigators will be able to analyze the IMA and normalized IMA distributions with respect to gender factor and correlation with the three listed blood tests (ferritin, transferrin and serum iron).

Official Title
-----------------
Ischemia Modified Albumin (IMA) Expression in the Male and Female Population

Conditions
-----------------
Group Identification

Intervention / Treatment
-----------------
* Other: blood exams


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caucasic signed informative consensus Exclusion Criteria: patients wearing articular devices pregnant (for female) fractured patients patients with oncologic diseases, hemochromatosis, hepatic diseases, thalassaemia, diabetes, anemia (Hb<9)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| male under 45y<br>blood exams performed on males under 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) | Other: blood exams<br>* in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin<br>|
| male over 45y<br>blood exams performed on males over 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) | Other: blood exams<br>* in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin<br>|
| fertile female<br>blood exams performed on fertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) | Other: blood exams<br>* in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin<br>|
| infertile female<br>blood exams performed on infertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) | Other: blood exams<br>* in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMA dosage | Dosage of IMA (mg/ml), with ELISA assay for each patient | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron, transferrin dosages | Dosage of iron and transferrin (mg/ml) values in patients blood | one year | 
| Ferritin dosages | Dosage of ferritin (ng/ml) values in patients blood | one year |