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Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

NCT number NCT02894671
Study type Observational
Source Istituto Ortopedico Rizzoli
Status Completed
Phase N/A
Start date February 2015
Completion date February 2016

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