View Clinical Trial (Medical Research Study)
A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures
| City: |
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Columbia |
| State: |
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Missouri |
| Zip Code: |
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65212 |
| Conditions: |
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Fracture |
| Purpose: |
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This post-market clinical study is being done to evaluate the use of the NovaLign™
Intramedullary Fixation System in the treatment of humeral fractures.
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| Study Summary: |
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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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| Criteria: |
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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.
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| NCT ID: |
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NCT00969839 |
| Primary Contact: |
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Principal Investigator
B Crist, MD
University of Missouri-Columbia
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbia, Missouri 65212
United States
B Crist, MD
Phone: 573-884-0854
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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