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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Group Identification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* 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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes