Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
Recruitment status was Not yet recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming|
- Bone union and callus formation,bone alignment, nail and screws resistance over time [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: single arm
In this single arm study, the Quantum nailing system will be used in all patients.
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087463
|Contact: Gili Laufer, Orthopedic firstname.lastname@example.org|
|Hilel Yafe Medical Center||Not yet recruiting|
|Hadera, Israel, 38100|
|Contact: Gili Laufer, Orthopedic +972503299680 email@example.com|
|Principal Investigator: Gili Laufer, Orthopedic|
|Principal Investigator:||Gili Laufer, Orthopedic||Hilel Yafe Medical Center|