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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01087463
Other study ID # N.M.B. P_HY Q REV I 09.09
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 14, 2010
Last updated March 14, 2010
Start date April 2010
Est. completion date April 2012

Study information

Verified date February 2010
Source N.M.B. Medical Applications Ltd
Contact Gili Laufer, Orthopedic sergeon
Phone +972503299680
Email michalla@netvision.net.il
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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date April 2012
Est. primary completion date April 2011
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


Intervention

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

Locations

Country Name City State
Israel Hilel Yafe Medical Center Hadera

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,bone alignment, nail and screws resistance over time up to 6 months Yes
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