Intramedullary Fixation of Humerus Fractures
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:||A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures|
- Bone union and callus formation [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
- Bone alignment [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
- Nail and screws resistance over time [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
Other Name: Quantum
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017289
|Contact: Michael Bernstein, Orthopedic||+972 50 544 0966|
|Rabin Medical Center|
|Petah Tikva, Israel, 49100|
|Principal Investigator:||Michael Berenstein, md||Rabin hospital|