Condition 1: Femur fracture. Condition 2: Tibia fracture. Condition 3: Tibia fracture. Fracture of femur Fracture of upper end of tibia Fracture of shaft of tibia
Conditions
Interventions
Intervention 1: The intervention group in the first phase of the study: this group with 10 participants will receive 60 mg of liposomal celastrol solution daily for 14 days. Intervention 2: The interv
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Willingness to cooperate and complete the informed consent form by the patient 18 to 60 years old Closed fracture of femur and tibia Body mass index = 35 kg/m2 SSI score between 9 and 15 Candidates for open fixation surgery Move without help from 2 months before the fracture No need for other formulas due to a special problem (kidney, lung, liver, etc.) Non malabsorption syndrome Non parathyroid gland disorders Absence of hepatic encephalopathy and liver cirrhosis Non myocardial infarction in the last month Non uncompensated congestive heart failure Non lower limb amputation Non angina symptoms Non Chest pain or shortness of breath (including severe COPD) Non kidney failure (blood creatinine lower than 1.2 mg/dL in men and 1.1 mg/dL in women/ GFR=90) Non Hepatic failure (AST = 109 U/l, ALT = 97 U/l and INR = 1.5) No metastatic cancer No infection and sepsis No uncontrolled blood pressure No cognitive impairment (3MS score > 73) Not taking drugs that affect bone metabolism, such as calcitonin, bis-phosphonates and corticosteroids Not taking albumin solution before and after surgery Not taking supplements or formulas that strengthen the immune system including : Arginine, glutamine, vitamins C and E, selenium, zinc or omega-3 fatty acids during the last 2 weeks before the start of the intervention No allergy or lactose intolerance
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of bone union rate. Timepoint: Bone union is assessed at 1, 3 and 6 months after surgery. Method of measurement: Radiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of serum C-reactive protein concentrations. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample.;Comparison of interleukin-6 level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample.;Comparison of serum alkaline phosphatase level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample.;Comparison of serum osteocalcin level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample.;Comparison of complete blood count. Timepoint: This variable will be measured at baseline, 7, 14, and 90 days after surgery. Method of measurement: Blood sample.;Comparison of serum leptin level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample.;Comparison of pain score. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: visual analog scale.;Comparison of disability score. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: Oswestry Disability questionnaire.;Comparison of calf circumference. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: measurement.;Comparison of physical function. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: Harris hip score questionnaire.;Comparison of wound infection. Timepoint: This variable will be measured at baseline,14, and 30 days after surgery. Method of measurement: Southampton scale.;Liver function tests (ALT-ALK-AST-Bilirubin- PT-INR). Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: Blood sample.;Renal test | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactfaezeh gouhari
Shahid Beheshti University of Medical Sciences
Outcome results
None listed