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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quantum | Experimental | In this single arm study, the Quantum nailing system will be used in all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantum | Device | Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System. |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Bernstein, Orthopedic | Contact | +972 50 544 0966 |
| Name | Affiliation | Role |
|---|---|---|
| Michael Berenstein, md | Rabin hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
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| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| D005598 | Fractures, Spontaneous |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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