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Intramedullary Fixation of Humerus Fractures

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ClinicalTrials.gov Identifier: NCT01017289
Recruitment Status : Unknown
Verified November 2009 by N.M.B. Medical Applications Ltd.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
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.

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. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Quantum
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.



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


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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.

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): NCT01017289


Contacts
Contact: Michael Bernstein, Orthopedic +972 50 544 0966

Locations
Israel
Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
N.M.B. Medical Applications Ltd
Investigators
Principal Investigator: Michael Berenstein, md Rabin hospital

Responsible Party: Michael Bernstein, Senior Orthopedic Surgeon, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01017289     History of Changes
Other Study ID Numbers: N.M.B. P Q REV I 03.09
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Fractures, Spontaneous
Wounds and Injuries
Arm Injuries