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Keep this study
Lead
NovaLign Orthopaedics, Inc
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Humeral Fracture
Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular 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.
Clareo Health | NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures
