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
  Purpose

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 Intervention
Humeral Fractures
Pathological Fractures
Device: Quantum

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures

Resource links provided by NLM:


Further study details as provided by N.M.B. Medical Applications Ltd:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Quantum

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 19, 2009
Last Updated: November 19, 2009
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on October 21, 2014