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IRCT20161121031003N3 IRCT 2019-04-16 Iran University of Medical Sciences Effect of PLGA( poly lactic Co-glycolic acid) system loaded with Deferoxamine in Osteonecrosis of the femur head Comparative study of the effectiveness of the PLGA( poly lactic Co-glycolic acid) system loaded with Deferoxamine with Core decompression alone in treatment of patients with early stage of Osteonecrosis of the femur head 2019-01-21 anticipated 20 Complete https://irct.ir/trial/36706 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized method is simple and using random number table, patients are divided into two groups: intervention and control. 3 osteonecrosis of the femoral head. Intervention 1: Intervention group: Patients in the intervention group after admission in the operating room according to the location of the osteonecrosis indicated in radiography, MRI and CT Scan with fluoroscopy guide will first be placed under the core decopression, and immediately the PLGA -defroxamine system will be placed in the same place. to prepare the PLGA -defroxamin system In this study, a scaffold of PLGA with a molecular weight of 25 kilodalton from Sigma Company is prepared using salt-leaching technique. Then, on each PLGA scaffold, 500 miligrams of dexroxamine are loaded. Intervention 2: Control group: Patients in the control group after admission to the operating room according to the location of the osteonecrosis indicated in the radiography, MRI and CT scan with fluorescope guide will be located only under the core decopression at the specified location. Yes - There is a plan to make this available What will be shared: All information in both groups includes changes in MRI, CT Scan and radiography, as well as changes in VAS and modified merle dAubigne scale Publishable. When: after collect all data To whom: for all of the people Conditions: no special condition Where to obtain: Shafa Yahyayian hospital library .Mojahedin eslam street ,Baharestan square Email: sajadnoori85@yahoo.com Email: gharanizadeh.k@iums.ac.ir How to obtain: Email to mentioned address .In the libarary of Shafayahyayian hospital ,thesis of Dr.Sajad Noori Garavand Comments:
public Sajad Noori Garavand
Mojahedin Eslam St, District 12, Tehran,Tehran Province
Tehran Iran (Islamic Republic of) 1449614535 +98 21 3354 2005 Gharanizadeh.k@iums.ac.ir Iran University of Medical Sciences scientific Doctor Mohammad Ali Sharifi
Iran University of Medical Sciences, Between Chamran and Sheikh Fazlallah, hemmat highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 3354 2000 Sharifalim@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age > 18 years ARCO stage 1 or 2 Idiopathic, steroid and alcohol induced, associated with lupus and sickel cell anemia 18 years 50 years Both Age> 50 years previous history of pelvic surgery An underlying condition that prevents surgery such as heart or lung disease M91.9 Juvenile osteochondrosis of hip and pelvis, unspecified Treatment - Surgery Treatment - Surgery Intervention group: Patients in the intervention group after admission in the operating room according to the location of the osteonecrosis indicated in radiography, MRI and CT Scan with fluoroscopy guide will first be placed under the core decopression, and immediately the PLGA -defroxamine system will be placed in the same place. to prepare the PLGA -defroxamin system In this study, a scaffold of PLGA with a molecular weight of 25 kilodalton from Sigma Company is prepared using salt-leaching technique. Then, on each PLGA scaffold, 500 miligrams of dexroxamine are loaded. Control group: Patients in the control group after admission to the operating room according to the location of the osteonecrosis indicated in the radiography, MRI and CT scan with fluorescope guide will be located only under the core decopression at the specified location Femoral head necrosis rate. Timepoint: At the beginning of the study (before the intervention) and 6 months and 12 months after the intervention, the hip joint MRI will be performed. Method of measurement: MRI. Clinical status of patients. Timepoint: All patients will be examined prior to the intervention and at intervals of 2 weeks and 1-3-6 and 12 months after the intervention. Method of measurement: modified merle dAubigne scale. Pain. Timepoint: All patients will be examined prior to the intervention and at intervals of 2 weeks and 1-3-6 and 12 months after the intervention. Method of measurement: visual analog score. Cysts and subchondral sclerosis. Timepoint: All patients will be examined prior to the intervention and at intervals of 2 weeks and 1-3-6 and 12 months after the intervention. Method of measurement: pelvic radiography. The amount of collapse in femural head. Timepoint: At the beginning of the study (before the intervention) and 6 months and 12 months after the intervention. Method of measurement: Pelvic CT Scane. Iran University of Medical Sciences Approved 2019-01-26 Ethics committee of Iran University of Medical Sciences Mojahedin eslam tehran Tehran Iran (Islamic Republic of)