Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

Not Applicable

• Conditions: Humeral Fractures; Pathological Fractures
• Interventions: Device: Quantum

• Registration Number: NCT01087463
• 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 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.

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-03-14
• Study First Submitted QC: 2010-03-14
• Last Update Submitted: 2010-03-14
• Study First Posted: 2010-03-16
• Last Update Posted: 2010-03-16
• Study Start: 2010-04
• Primary Completion: 2011-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	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,bone alignment, nail and screws resistance over time	up to 6 months

Trial Locations

Locations (1)

Hilel Yafe Medical Center; 🇮🇱 Hadera, Israel