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Completed

NCT Number: NCT02894671

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

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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Key information

Conditions

Group Identification Behavior Social Behavior Social Identification

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica

Bologna, Italy, 40136

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

blood exams

Other

in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin

Primary outcomes

  1. IMA dosage

    Time frame: one year

    Dosage of IMA (mg/ml), with ELISA assay for each patient

Secondary outcomes

  1. iron, transferrin dosages

    Time frame: one year

    Dosage of iron and transferrin (mg/ml) values in patients blood

  2. Ferritin dosages

    Time frame: one year

    Dosage of ferritin (ng/ml) values in patients blood

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: IMAandGENDER

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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