Reconstruction of human nonunion of tibia fractures
- Conditions
- Disorders of continuity of bone.Nonunion of fracture [pseudarthrosis]
- Registration Number
- IRCT201507291031N7
- Lead Sponsor
- Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
1-patients with 18-65 years old; 2- both male & female patients; 3- patients with nonunion of tibial midshaft; 4- Fracture must be located in the middle third of the tibia; 5- Nonunion gap must be less than 1 cm. in the radiology; 6- Fracture fixed by closed intra medullary rod; 7- Patient informed the consent; 8- Atrophic type nonunion; 9- 6 months last from the first operation; 10- Second procedure for nonunion has not done.
Exclusion criteria:1- infected nonunion; 2- Multiple major fractures; 3- Major untreated fracture; 4- History of cancer; 5- Allergy to protein or other cell culture medium gradients; 6- Uncontrolled chronic diseases; 7- Need to steroid usage in the period of treatment; 8- Positive for HIV or other viral diseases; 9- Pregnant or lactating women; 10- Include in other trail
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone fusion. Timepoint: 3 months after injection. Method of measurement: before and after injection radiology photographs.
- Secondary Outcome Measures
Name Time Method Pain. Timepoint: 1-3- 6-12 months after injection. Method of measurement: VAS.;Tumor formation in contrast with placebo group. Timepoint: 1-3-6-12 months. Method of measurement: graphy.;Walking distance. Timepoint: 1-3- 6-12 months after injection. Method of measurement: Questionnaire.