Status:
UNKNOWN
NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures
Lead Sponsor:
NovaLign Orthopaedics, Inc
Conditions:
Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00969839
Start Date
September 1 2009
End Date
March 1 2011
Last Update
September 18 2009
Active Locations (2)
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1
Denver Health Medical Center
Denver, Colorado, United States, 80204
2
University of Missouri - Columbia
Columbia, Missouri, United States, 65212