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

Status unconfirmed · Phase 4

Conditions studied: Fracture

In brief

This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.

Key facts

Study ID

NCT00969839

Run by

NovaLign Orthopaedics, Inc

People needed

20

Starts

2009-09-01

Expected to finish

2011-03-01

Last updated by the study team

2009-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Denver Health Medical Center — Denver, Colorado, United States (enrolling)
• University of Missouri - Columbia — Columbia, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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