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The Kiva® System as a Vertebral Augmentation Treatment (KAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benvenue Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01123512
First received: May 11, 2010
Last updated: October 1, 2014
Last verified: October 2014
Results First Received: August 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Spinal Fractures
Fractures, Compression
Back Injuries
Intervention: Device: Vertebral augmentation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Kiva VCF Treatment System The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
Balloon Kyphoplasty The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.

Participant Flow:   Overall Study
    Kiva VCF Treatment System     Balloon Kyphoplasty  
STARTED     153     147  
COMPLETED     127     126  
NOT COMPLETED     26     21  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-Treated population

Reporting Groups
  Description
Kiva VCF Treatment System The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
Balloon Kyphoplasty The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
Total Total of all reporting groups

Baseline Measures
    Kiva VCF Treatment System     Balloon Kyphoplasty     Total  
Number of Participants  
[units: participants]
  144     141     285  
Age  
[units: years]
Mean ± Standard Deviation
  76.03  ± 8.82     75.09  ± 9.62     75.57  ± 9.22  
Gender  
[units: participants]
     
Female     105     106     211  
Male     39     35     74  



  Outcome Measures

1.  Primary:   Proportion of Participants With Study Success   [ Time Frame: 12 Month Post-op ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Barbara S. Lindsay, Vice President Clinical & Regulatory Affairs
Organization: Benvenue Medical, Inc.
phone: 408-454-9300
e-mail: blindsay@benvenuemedical.com


No publications provided


Responsible Party: Benvenue Medical, Inc.
ClinicalTrials.gov Identifier: NCT01123512     History of Changes
Other Study ID Numbers: BEN005
Study First Received: May 11, 2010
Results First Received: August 6, 2014
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes