Clinical Trial: Intramedullary Fixation of Humerus Fractures
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures
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. 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 [ Time Frame: up to 6 months ]
- Bone alignment [ Time Frame: up to 6 months ]
- 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: November 19, 2009
Date Started: December 2009
Date Completion: December 2011
Last Updated: November 19, 2009
Last Verified: November 2009
