6 Clinical Trials for Various Conditions
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.
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.
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.
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).
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.
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.