View clinical trials related to Nonunion of Fracture.
Filter by:This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a common treatment for tibia shaft fractures in adults. The study group will have a bone graft applied to the open cortex of the fracture. The bone graft will be composed of the intramedullary reamings, which are a byproduct produced when the intramedullary canal is reamed in preparation for insertion of the IMN.
Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union. On the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate. Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment. Clinical union consider to relief pain in non union site and be stable in examination.