Effect of PLGA( poly lactic Co-glycolic acid) system loaded with Deferoxamine in Osteonecrosis of the femur head
Phase 3
Completed
- Conditions
- osteonecrosis of the femoral head.Juvenile osteochondrosis of hip and pelvis, unspecified
- Registration Number
- IRCT20161121031003N3
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Age > 18 years
ARCO stage 1 or 2
Idiopathic, steroid and alcohol induced, associated with lupus and sickel cell anemia
Exclusion Criteria
Age> 50 years
previous history of pelvic surgery
An underlying condition that prevents surgery such as heart or lung disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.