An observational study in Group Identification, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by Istituto Ortopedico Rizzoli · Observational
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).
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's enrollment of 100 is below the median of 181 across 617 observational studies indexed under Ischemia.
Browse Ischemia studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
25 males under 45y, 25 males over 45y, 25 fertile females and 25 infertile females
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)
Other: 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)
Other: 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)
Other: 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)
Other: blood exams
in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
IMA dosage
Dosage of IMA (mg/ml), with ELISA assay for each patient
Time frame: one year
iron, transferrin dosages
Dosage of iron and transferrin (mg/ml) values in patients blood
Time frame: one year
Ferritin dosages
Dosage of ferritin (ng/ml) values in patients blood
Time frame: one year
Plan to share: No
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli