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The Kiva® System as a Vertebral Augmentation Treatment

NCT01123512 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-10-09

Study results available
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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.

Conditions

  • Spinal Fractures
  • Fractures, Compression
  • Back Injuries

Interventions

DEVICE

Vertebral augmentation

Vertebral augmentation for one or two osteoporotic vertebral compression fractures

Sponsors & Collaborators

  • Benvenue Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven R. Garfin, MD · University of California, San Diego, CA

  • Sean M. Tutton, MD, FSIR · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123512 on ClinicalTrials.gov