Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

Humeral Fractures Clinical Trial

Official title: Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

Status Not yet recruiting

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.

Clinical Trial Description

The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle and without preliminary reaming. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Pathological Fractures

• NCT number: NCT01087463
• Study type: Interventional
• Source: N.M.B. Medical Applications Ltd
• Contact: Gili Laufer, Orthopedic sergeon
• Phone: +972503299680
• Email: michalla@netvision.net.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2010
• Completion date: April 2012