Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 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:
NCT01087463
First received: March 14, 2010
Last updated: NA
Last verified: February 2010
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: Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

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,bone alignment, nail and screws resistance over time [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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: NCT01087463

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

Locations
Israel
Hilel Yafe Medical Center Not yet recruiting
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
Principal Investigator: Gili Laufer, Orthopedic Hilel Yafe Medical Center
  More Information

No publications provided

Responsible Party: Gili Laufer, Hilel Yafe Medical Center
ClinicalTrials.gov Identifier: NCT01087463     History of Changes
Other Study ID Numbers: N.M.B. P_HY Q REV I 09.09
Study First Received: March 14, 2010
Last Updated: March 14, 2010
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on October 01, 2014