Intramedullary Fixation of Humerus Fractures
- Conditions
- Humeral FracturesPathological Fractures
- Interventions
- Device: Quantum
- Registration Number
- NCT01017289
- Lead Sponsor
- N.M.B. Medical Applications Ltd
- 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 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Above 18 years old.
- Mid shaft diaphyseal fracture
- Acute fracture
- Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
- Ongoing infection in fracture site.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Quantum Quantum In this single arm study, the Quantum nailing system will be used in all patients.
- Primary Outcome Measures
Name Time Method Bone union and callus formation up to 6 months Bone alignment up to 6 months Nail and screws resistance over time up to 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rabin Medical Center
🇮🇱Petah Tikva, Israel