Clinical Trial: The Kiva® System as a Vertebral Augmentation Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.
Detailed Summary:
Sponsor: Benvenue Medical, Inc.
Current Primary Outcome: Proportion of Participants With Study Success [ Time Frame: 12 Month Post-op ]
Patient success will be defined as:
- Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),
- Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and
- Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Benvenue Medical, Inc.
Dates:
Date Received: May 11, 2010
Date Started: July 2010
Date Completion:
Last Updated: October 1, 2014
Last Verified: October 2014
