An interventional study of Quantum in Humeral Fractures and Pathological Fractures, sponsored by N.M.B. Medical Applications Ltd. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-11-20.
Sponsored by N.M.B. Medical Applications Ltd · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 20 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →N.M.B. Medical Applications Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this single arm study, the Quantum nailing system will be used in all patients.
Device: Quantum
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
Bone union and callus formation
Time frame: up to 6 months
Bone alignment
Time frame: up to 6 months
Nail and screws resistance over time
Time frame: up to 6 months
This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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N.M.B. Medical Applications Ltd