Intramedullary Fixation of Humerus Fractures

Humeral Fractures Clinical Trial

Official title:

A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01017289
• Other study ID #: N.M.B. P Q REV I 03.09
• Status: Not yet recruiting
• Phase: N/A
• First received: November 19, 2009
• Last updated: November 19, 2009
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2009
• Source: N.M.B. Medical Applications Ltd
• Contact: Michael Bernstein, Orthopedic
• Phone: +972 50 544 0966
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Pathological Fractures

Intervention

Device:
• Quantum
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
N.M.B. Medical Applications Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone union and callus formation		up to 6 months	Yes
Primary	Bone alignment		up to 6 months	Yes
Primary	Nail and screws resistance over time		up to 6 months	Yes