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NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures

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. Identifier: NCT00969839
Recruitment Status : Unknown
Verified September 2009 by NovaLign Orthopaedics, Inc.
Recruitment status was:  Recruiting
First Posted : September 1, 2009
Last Update Posted : September 18, 2009
Information provided by:
NovaLign Orthopaedics, Inc

Brief Summary:
This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.

Condition or disease Intervention/treatment Phase
Fracture Device: NovaLign Intramedullary Fixation System Phase 4

Detailed Description:
This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.

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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 to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures
Study Start Date : September 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intramedullary Fixation System
Humeral fractures to be treated with the Intramedullary Fixation System
Device: NovaLign Intramedullary Fixation System
Intramedullary fixation of broken humerus

Primary Outcome Measures :
  1. Radiographic union and safety [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Function, pain, and quality of life assessments at regular intervals [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Humeral Fracture
  • Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria)
  • Fully functioning contralateral limb (e.g., hand, arm, shoulder)
  • Age 18 years or older and skeletally mature

Exclusion Criteria:

  • Intraarticular fractures or those involving shoulder or elbow of the index arm
  • Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion)
  • Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy
  • Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens
  • Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.

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 identifier (NCT number): NCT00969839

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United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: S Morgan, MD    303-602-3796      
Contact: A Baron    (303) 602-3796      
Principal Investigator: S Morgan, MD         
United States, Missouri
University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65212
Contact: B Crist, MD    573-884-0854      
Contact: L Anderson, RN    (573) 884-0854      
Principal Investigator: B Crist, MD         
Sponsors and Collaborators
NovaLign Orthopaedics, Inc
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Principal Investigator: B Crist, MD University of Missouri-Columbia

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Responsible Party: Dawn Norman, Director, Clinical Affairs, NovaLign Orthopaedics Identifier: NCT00969839     History of Changes
Other Study ID Numbers: SP-001
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009
Keywords provided by NovaLign Orthopaedics, Inc:
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries