NCT01087463

Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: N.M.B. Medical Applications Ltd · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Humeral Fractures
• Pathological Fractures

Interventions

Type	Name	Description
DEVICE	Quantum	Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-04-01
• Completion: 2012-04-01
• First posted: 2010-03-16
• Last updated: 2010-03-16

Locations

1 site across 1 country: Israel