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Intramedullary Fixation of Humerus Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by N.M.B. Medical Applications Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
N.M.B. Medical Applications Ltd
ClinicalTrials.gov Identifier:
NCT01017289
First received: November 19, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 19, 2009
November 19, 2009
December 2009
December 2010   (final data collection date for primary outcome measure)
  • Bone union and callus formation [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • Bone alignment [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • Nail and screws resistance over time [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Intramedullary Fixation of Humerus Fractures
A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Humeral Fractures
  • Pathological Fractures
Device: Quantum
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
Other Name: Quantum
Experimental: Quantum
In this single arm study, the Quantum nailing system will be used in all patients.
Intervention: Device: Quantum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
December 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Michael Bernstein, Orthopedic +972 50 544 0966
Israel
 
NCT01017289
N.M.B. P Q REV I 03.09
No
Michael Bernstein, Senior Orthopedic Surgeon, Rabin Medical Center
N.M.B. Medical Applications Ltd
Not Provided
Principal Investigator: Michael Berenstein, md Rabin hospital
N.M.B. Medical Applications Ltd
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP