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

Completed

• Conditions: Group Identification
• Interventions: Other: blood exams

• Registration Number: NCT02894671
• Lead Sponsor: Istituto Ortopedico Rizzoli

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).

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-02-12
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-05
• Last Update Submitted: 2016-09-05
• Study First Posted: 2016-09-09
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
male over 45y	blood exams	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)
male under 45y	blood exams	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)
fertile female	blood exams	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	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)

Primary Outcome Measures

Name	Time	Method
IMA dosage	one year	Dosage of IMA (mg/ml), with ELISA assay for each patient

Secondary Outcome Measures

Name	Time	Method
iron, transferrin dosages	one year	Dosage of iron and transferrin (mg/ml) values in patients blood
Ferritin dosages	one year	Dosage of ferritin (ng/ml) values in patients blood

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica; 🇮🇹 Bologna, Italy