Evalution of stimulating union with stem cells in long bone
Phase 2
- Conditions
- Condition 1: nonunion of femoral fractures. Condition 2: nonunion of tibial fractures.Unspecified fracture of unspecified femur, subsequent encounter for closed fracture with nonunion, subsequent encounter for open fracture type I or II with nonunion, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with nonunionsubsequent encounter for closed fracture with nonunion, subsequent encounter for open fracture type I or II with nonunion, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with nonunionS72.90, S7S82.209K,
- Registration Number
- IRCT2015102521482N2
- Lead Sponsor
- Vice chancellor for research Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
patients with history of tibial and femoral nonunion; age 18 to 60; patients who can be available for follow-up duration.
Exclusion criteria: known cases of cancer; pregnant; HIV; patients with associated fractures who cannot weight-bearing; sign and symptoms of infected non-unions.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nion. Timepoint: 2 weeks, 3 months and 6 months after intervention. Method of measurement: X-Ray, physical examination.
- Secondary Outcome Measures
Name Time Method Time duration of union. Timepoint: 2 weeks, 3 months and 6 months after intervention. Method of measurement: Days, X-ray, physical examination.;Nonunion. Timepoint: 6 months after intervention. Method of measurement: X-Ray, physical examination.;Surgical site infection. Timepoint: 2 days, 2 weeks, 3 months after intervention. Method of measurement: physical examination, ESR and CRP lab tests.;Duration of anesthesia. Timepoint: at the time of operation in operating room. Method of measurement: inspection.;Pain. Timepoint: before, 3 and 6 months after surgery. Method of measurement: Visual Analog Scale (VAS).;Function. Timepoint: before, 3 and 6 months after surgery. Method of measurement: Lower Extremity Functional Score (LEFS).