Long bone fracture Injury, Occupational Diseases, Poisoning Fracture
Conditions
Interventions
All patients will receive standardised first fracture surgery (closed or open reduction). At enrolment patients are randomised to receive either injection (intervention group) or observation (control
Sponsors
Individual sponsor (South Korea)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Long bone fracture (femur, tibia, radius, ulna, humerus) patients 2. Aged 15 and 65 years, either sex 3. Approximately six weeks after the first open or closed reduction, the score of callus formation was lower than 3 points 4. Individuals who have completed a written consent form
Exclusion criteria
Exclusion criteria: 1. Patient who is oversensitive to bovine protein 2. Patients with a known history of anaphylaxis to gentamicin 3. Patients with acute infection in bone defects 4. Patients who have communicable disease (positive reaction against human immunodeficiency virus [HIV], hepatitis C virus [HCV], hepatitis B virus [HBV], cytomegalovirus [CMV], syphilis, human T-lymphotropic virus [HTLV]) 5. Patients diagnosed by the investigators to have psychological disorders 6. Patients whose score of callus formation was higher than 4 points
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of Callus Formation Score for two months after autologous cultured osteoblast injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Korea, South
Outcome results
None listed