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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by NovaLign Orthopaedics, Inc.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NovaLign Orthopaedics, Inc
ClinicalTrials.gov Identifier:
NCT00969839
First received: August 30, 2009
Last updated: September 16, 2009
Last verified: September 2009
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by NovaLign Orthopaedics, Inc:

Primary Outcome Measures:
  • Radiographic union and safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Function, pain, and quality of life assessments at regular intervals [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
Other Name: NovaLign Intramedullary Fixation System

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969839

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

No publications provided

Responsible Party: Dawn Norman, Director, Clinical Affairs, NovaLign Orthopaedics
ClinicalTrials.gov Identifier: NCT00969839     History of Changes
Other Study ID Numbers: SP-001
Study First Received: August 30, 2009
Last Updated: September 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by NovaLign Orthopaedics, Inc:
Fracture
Humerus
Intramedullary
Fixation

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

ClinicalTrials.gov processed this record on May 23, 2013