Humeral Fractures, Pathological Fractures
Conditions
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.
Interventions
DEVICEQuantum
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
Sponsors
N.M.B. Medical Applications Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Above 18 years old. * Mid shaft diaphyseal fracture * Acute fracture
Exclusion criteria
* Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes. * Ongoing infection in fracture site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Israel
Contacts
Primary ContactMichael Bernstein, Orthopedic
Outcome results
None listed