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 nonunion subsequent encounter for closed fracture with nonunion, subsequent encounter for open fracture type I or II with nonunion, subsequent encounter for open fracture type
Conditions
Interventions
Intervention 1: The control group gets standard treatment with placement of iliac bone graft in site of non-union. Intervention 2: For the case or intervention group
bone marrow taken from the iliac crest with Jamshidi needle and local anesthesia is concentrated to use stem cells on collagen scaffold and implanting it into the tibial and femural non-union site.
Treatment - Surgery
The control group gets standard treatment with placement of iliac bone graft in site of non-union.
For the case or intervention group
Sponsors
Vice chancellor for research Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Union. Timepoint: 2 weeks, 3 months and 6 months after intervention. Method of measurement: X-Ray, physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Hejrati
Orthopedic research center, Shahid Kamyab Hospital, Mashhad University of Medical Sciences
Outcome results
None listed