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Nonunion of Fracture clinical trials

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NCT ID: NCT05699174 Recruiting - Amputation Clinical Trials

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

POvIV2
Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05613257 Completed - Tibial Fractures Clinical Trials

Distal Targeter vs Free-hand

Start date: October 31, 2022
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.

NCT ID: NCT05163795 Completed - Clinical trials for Nonunion of Fracture

Distal Femur Fracture Nonunion - Statistical Analysis Plan

Start date: May 15, 2019
Phase:
Study type: Observational

Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

NCT ID: NCT04340284 Completed - Clinical trials for Nonunion of Fracture

Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion

Start date: November 10, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Nonunion is a major complication of fractures.Per cutaneous bone marrow concentrate (BMC) application around fracture ends is being utilized with great success . Mesenchymal Stem Cells (MSCs)are one of the major cell types found in BMC responsible for results Adipose tissue is an alternative source for MSCs. Besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration. this retrospective analysis to report the outcome in patients treated with fluoroscopic guided percutaneous injection of SVF at the site of fracture as an outpatient procedure between November 2012 to August 2018.

NCT ID: NCT04299022 Recruiting - Fractures, Bone Clinical Trials

Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care

Start date: June 1, 2021
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT03937310 Enrolling by invitation - Clinical trials for Nonunion of Fracture

NGS for Non-unions

Start date: January 3, 2019
Phase:
Study type: Observational

The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.

NCT ID: NCT03891888 Recruiting - Tibial Fractures Clinical Trials

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

Start date: March 26, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03129971 Active, not recruiting - Clinical trials for Nonunion of Fracture

Platelet-rich Plasma Combined With Conventional Surgery in the Treatment of Atrophic Nonunion of Femoral Shaft Fractures

Start date: August 2014
Phase: N/A
Study type: Interventional

To objectively analyze the effectiveness of platelet-rich plasma (PRP) combined with conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures.

NCT ID: NCT01958502 Recruiting - Clinical trials for Nonunion of Fracture

Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold

Start date: July 2013
Phase: Phase 2
Study type: Interventional

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.