Clinical Trial: Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: N.M.B. Medical Applications Ltd

Current Primary Outcome: Bone union and callus formation,bone alignment, nail and screws resistance over time [ Time Frame: up to 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: N.M.B. Medical Applications Ltd

Dates:
Date Received: March 14, 2010
Date Started: April 2010
Date Completion: April 2012
Last Updated: March 14, 2010
Last Verified: February 2010