The primary safety and efficacy evaluation endpoints to determine individual patient success are the Zurich Claudication Questionnaire (ZCQ), neurologic status, solid fusion for the control (spinal fusion) group.
Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.
50 Years to 85 Years (Adult, Senior)
January 4, 2007
February 5, 2009
† Study has passed its completion date and status has not been verified in more than two years.