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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| male under 45y | 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) |
| |
| male over 45y | 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) |
| |
| fertile female | 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) |
| |
| infertile female | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood exams | Other | in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin |
|
| Measure | Description | Time Frame |
|---|---|---|
| IMA dosage | Dosage of IMA (mg/ml), with ELISA assay for each patient | one year |
| 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 |
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25 males under 45y, 25 males over 45y, 25 fertile females and 25 infertile females
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Bracci, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica | Bologna | Italy | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18568173 | Background | Govender R, De Greef J, Delport R, Becker PJ, Vermaak WJ. Biological variation of ischaemia-modified albumin in healthy subjects. Cardiovasc J Afr. 2008 May-Jun;19(3):141-4. | |
| 22084701 | Background | Catalani S, Leone R, Rizzetti MC, Padovani A, Apostoli P. The role of albumin in human toxicology of cobalt: contribution from a clinical case. ISRN Hematol. 2011;2011:690620. doi: 10.5402/2011/690620. Epub 2010 Oct 31. |
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| ID | Term |
|---|---|
| D012933 | Social Identification |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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Serum vials
| one year |
| 11396981 | Background | Bar-Or D, Rael LT, Lau EP, Rao NK, Thomas GW, Winkler JV, Yukl RL, Kingston RG, Curtis CG. An analog of the human albumin N-terminus (Asp-Ala-His-Lys) prevents formation of copper-induced reactive oxygen species. Biochem Biophys Res Commun. 2001 Jun 15;284(3):856-62. doi: 10.1006/bbrc.2001.5042. |