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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by NovaLign Orthopaedics, Inc.
Recruitment status was:  Recruiting
Information provided by:
NovaLign Orthopaedics, Inc Identifier:
First received: August 30, 2009
Last updated: September 16, 2009
Last verified: September 2009
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 Intervention Phase
Fracture Device: NovaLign Intramedullary Fixation System Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by NovaLign Orthopaedics, Inc:

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

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

Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intramedullary Fixation System
Humeral fractures to be treated with the Intramedullary Fixation System
Device: NovaLign Intramedullary Fixation System
Intramedullary fixation of broken humerus

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  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 identifier: NCT00969839

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
Principal Investigator: B Crist, MD University of Missouri-Columbia
  More Information

Responsible Party: Dawn Norman, Director, Clinical Affairs, NovaLign Orthopaedics Identifier: NCT00969839     History of Changes
Other Study ID Numbers: SP-001
Study First Received: August 30, 2009
Last Updated: September 16, 2009

Keywords provided by NovaLign Orthopaedics, Inc:

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries processed this record on August 18, 2017