At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
Vertebral augmentationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial
In Brief
A Phase 3 clinical trial evaluating Vertebral augmentation for Spinal Fractures and 2 related conditions. Completed, enrolled 300 participants across 21 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Fractures, Fractures, Compression, Back Injuries
CountriesBelgium, Canada, France, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJul 2010
Primary CompletionMay 2013
TodayJul 2026
First PostedMay 14, 2010
Enrollment StartJul 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.1 years ago
Interventions
Vertebral augmentationdevice
Vertebral augmentation for one or two osteoporotic vertebral compression fractures