The Kiva® System as a Vertebral Augmentation Treatment

Phase 3

Completed

• Conditions: Spinal Fractures; Fractures, Compression; Back Injuries
• Interventions: Device: Vertebral augmentation

• Registration Number: NCT01123512
• Lead Sponsor: Benvenue Medical, Inc.

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-14
• Study Start: 2010-07
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-08-06
• Results First Submitted QC: 2014-08-06
• Results First Posted: 2014-08-21
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kiva VCF Treatment System	Vertebral augmentation	-
Balloon Kyphoplasty	Vertebral augmentation	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Study Success	12 Month Post-op	Patient success will be defined as: 1. Reduction in VCF fracture-related pain at 12 months by \>15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),; 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and; 3. 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

Trial Locations

Locations (21)

CORE Orthopaedic Medical Center; 🇺🇸 Encinitas, California, United States

El Camino Hospital; 🇺🇸 Mountain View, California, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Radiology Imaging Associates; 🇺🇸 Englewood, Colorado, United States

Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

Adventist Hospital; 🇺🇸 Hinsdale, Illinois, United States

Spine Institute of Louisiana; 🇺🇸 Shreveport, Louisiana, United States

Sierra Regional Spine Institute; 🇺🇸 Reno, Nevada, United States

Clinical Radiology of Oklahoma; 🇺🇸 Edmond, Oklahoma, United States

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

CHU Amiens Sud; 🇫🇷 Amiens, France

Universitatsklinikum Bonn; 🇩🇪 Bonn, Germany

Klinikum Ernst von Bergmann gGmbH; 🇩🇪 Potsdam, Germany

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

CHC Saint Joseph; 🇧🇪 Liege, Belgium

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Radiological Associates of Sacramento; 🇺🇸 Sacramento, California, United States

St. Mary's Spine Center; 🇺🇸 San Francisco, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Mayo Clinic-Rochester; 🇺🇸 Rochester, Minnesota, United States