Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

N.M.B. Medical Applications

Status: Unknown

Conditions: Humeral Fractures; Pathological Fractures

Treatments: Device: Quantum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01087463

N.M.B. P_HY Q REV I 09.09

Details and patient eligibility

About

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.

Full 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 and without preliminary reaming. 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

single arm

Experimental group

Description:

In this single arm study, the Quantum nailing system will be used in all patients.

Treatment:

Device: Quantum