Repair of bone fractures with scaffold and stem cells
Phase 2
- Conditions
- non-union scaphoid fracture.
- Registration Number
- IRCT20181222042074N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
All patients with non-union fractures in Scaphoid bone
Age between 18 and 60 years old
No infection at the fracture site
Patient availability for postoperative examinations
Fill conscious awareness
Individuals who want to refer for postoperative follow-up
Exclusion Criteria
Patients with other diseases, such as cancer.
Patients with other associated motor injuries preventing normal ability.
patients with infectious non-union fracture.
Pregnant patients
Patients have a positive HIV-positive serology or hepatitis B and C.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of bone formation. Timepoint: Before the intervention and 1, 3 and 6 months after surgery. Method of measurement: 1-Quick DASH, PRWE, Wrist Mayo Clinic 2- Flexion, Extension, Supination, Pronation, Ulnar & radial deviations 3- CT scan before and after surgery 4-Radiography.;The rate of callus tissue formation. Timepoint: Before the intervention and 1, 3 and 6 months after surgery. Method of measurement: Radiographs and CT scans.
- 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).