Osteonecrosis of femoral head. Juvenile osteochondrosis of hip and pelvis
Conditions
Interventions
Intervention group: Injection of hydrogel based on carboxymethyl chitosan and carboxymethyl cellulose polymers containing angiogenesis peptide (QK) simultaneously with core-decompression surgery, once
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with osteonecrosis of the femoral head Stages I (IA-IC), II (IIA-IIC), and IIIA, according to the osteonecrosis classification (Steinberg), with diagnosis based on MRI findings. Adjusted necrosis index less than 40 and idiopathic and non-idiopathic osteonecrosis Absence of infection in the bone involved at the time of surgery The patient is ready to give informed consent Normal organ and bone marrow function is as follows: leukocyte count greater than or equal to 3000 per microliter; complete neutrophil count greater than or equal to 1500 per microliter; platelet count greater than or equal to 140,000 per microliter; AST/ALT less than 2.5 times the standard level; normal serum creatinine, based on the normal clinical laboratory range Patients with a history of corticosteroid use or currently using corticosteroids can only enter the study if their medication has been discontinued one month before and six months after the hydrogel injection; patients treated with oral bisphosphonates must discontinue their medication six months before entering the study
Exclusion criteria
Exclusion criteria: Osteonecrosis of the femoral head bone in stages IIIB or more severe, as detected by MRI; flattening of the femoral head (stage IV) or collapse of the articular cartilage Patients have indications for joint replacement Septic arthritis; Stress fracture, or metabolic disease other than osteonecrosis of the bone (e.g., Paget's disease of bone, osteogenesis imperfecta, primary parathyroidism; fibrotic dysplasia [monocystic or polycystic McCann-Albright syndrome] Any active treatment with bisphosphonates or any history of intravenous therapy Positive tests for AIDS and syphilis at the time of screening; active hepatitis B or C infection at the time of screening Chemotherapy, radiation therapy, or immunotherapy within the past 2 years Immunodeficiency diseases Patients on antidepressants Patients who are being treated with one of the drugs associated with heart, liver, or kidney failure Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial Internal devices incompatible with MRI (pacemaker, aneurysm clip, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of hydrogel injection containing angiogenesis peptide (QK). Timepoint: 2, 4, and 8 weeks after hydrogel injection. Method of measurement: Laboratory tests of CBC/Diff for inflammation evaluation, BUN/CR for Kidney evaluation, ALT/AST/Bilirubin for liver evaluation, Magnetic Resonance Imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Life quality improving. Timepoint: All patients before the intervention and at 2, 4, and 8 weeks intervals after hydrogel injection. Method of measurement: Short Form Healthy Survey-36 and Side Effects Questionnaire.;The rate of femoral head necrosis. Timepoint: All patients before the intervention and at 2, 4, and 8 weeks intervals after hydrogel injection. Method of measurement: Magnetic resonance imaging.;Pain. Timepoint: All patients before the intervention and at 2, 4, and 8 weeks intervals after hydrogel injection. Method of measurement: Visual Analog Scale Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Shayan Amiri
Iran University of Medical Sciences
Outcome results
None listed