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Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087463
Recruitment Status : Unknown
Verified February 2010 by N.M.B. Medical Applications Ltd.
Recruitment status was:  Not yet recruiting
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
N.M.B. Medical Applications Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Humeral Fractures Pathological Fractures Device: Quantum Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
Study Start Date : April 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: single arm
In this single arm study, the Quantum nailing system will be used in all patients.
 Device: Quantum
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.


Outcome Measures
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Primary Outcome Measures :
  1. Bone union and callus formation,bone alignment, nail and screws resistance over time [ Time Frame: up to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087463


Contacts
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Contact: Gili Laufer, Orthopedic sergeon +972503299680 michalla@netvision.net.il

Locations
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Israel
Hilel Yafe Medical Center
Hadera, Israel, 38100
Contact: Gili Laufer, Orthopedic    +972503299680    michalla@netvision.net.il   
Principal Investigator: Gili Laufer, Orthopedic         
Sponsors and Collaborators
N.M.B. Medical Applications Ltd
Investigators
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Principal Investigator: Gili Laufer, Orthopedic Hilel Yafe Medical Center
More Information
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Responsible Party: Gili Laufer, Hilel Yafe Medical Center
ClinicalTrials.gov Identifier: NCT01087463    
Other Study ID Numbers: N.M.B. P_HY Q REV I 09.09
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Fractures, Spontaneous
Wounds and Injuries
Arm Injuries