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KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures

This study has been terminated.
(Due to high number of patients terminating study early, low patient enrollment and difficulty in patient/investigator willingness for randomization)
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00323609
First received: May 5, 2006
Last updated: March 18, 2013
Last verified: June 2012
History of Changes
Results First Received: June 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Vertebral Body Compression Fractures
Interventions: Procedure: Vertebroplasty
Procedure: Kyphoplasty

  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
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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
Kyphoplasty This group of patients has received balloon kyphoplasty procedure.
Vertebroplasty This group of patients has received vertebroplasty procedure.
Kyphoplasty Not Treated Patients Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
Vertebroplasty Not Treated Patients Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.

Participant Flow:   Overall Study
    Kyphoplasty     Vertebroplasty     Kyphoplasty Not Treated Patients     Vertebroplasty Not Treated Patients  
STARTED     191     190     8     15  
COMPLETED     100 [1]   91 [1]   0     0  
NOT COMPLETED     91     99     8     15  
Death                 16                 21                 0                 0  
Lost to Follow-up                 9                 10                 0                 0  
Physician Decision                 2                 0                 0                 1  
Withdrawal by Subject                 11                 23                 4                 4  
Other non-VCF-related medical condition                 3                 2                 0                 0  
Sponsor discontinued trial                 29                 29                 0                 0  
Unrelenting or severe back pain                 1                 1                 0                 0  
Logistical withdrawal                 9                 5                 0                 1  
Other reason                 11                 8                 4                 9  
[1] Revision retains subjects with follow-up data in a visit window when terminated in same visit window



  Baseline Characteristics
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Reporting Groups
  Description
Kyphoplasty This group of patients has received balloon kyphoplasty procedure.
Vertebroplasty This group of patients has received vertebroplasty procedure.
Total Total of all reporting groups

Baseline Measures
    Kyphoplasty     Vertebroplasty     Total  
Number of Participants  
[units: participants]
 		  191     190     381  
Age  
[units: years]
Mean ± Standard Deviation 		  75.5  ± 10.3     75.7  ± 10.5     75.6  ± 10.4  
Gender  
[units: participants]
 		     
Female     151     144     295  
Male     40     46     86  
Race/Ethnicity, Customized  
[units: participants]
 		     
American Indian or Alaska Native     0     1     1  
Asian     1     2     3  
Black or African American     3     4     7  
Hispanic     8     2     10  
White     178     181     359  
Other     1     0     1  
Current Weight  
[units: lbs]
Mean ± Standard Deviation 		  154.0  ± 40.2     160.2  ± 42.9     157.1  ± 41.6  
Current Height  
[units: inches]
Mean ± Standard Deviation 		  63.8  ± 4.3     64.5  ± 4.0     64.1  ± 4.2  
Smoking Habit  
[units: participants]
 		     
Never Smoked     92     84     176  
Former Smoker     68     84     152  
Current Smoker     31     22     53  
Osteoporosis Cause  
[units: participants]
 		     
Suspected or confirmed primary osteoporosis     179     172     351  
Suspected or confirmed secondary osteoporosis     12     18     30  
Number of patients with intend to treat VCFs  
[units: participants]
 		     
One level of VCFs intend to treat     149     150     299  
Two levels of VCFs intend to treat     33     32     65  
Three levels of VCFs intend to treat     9     8     17  



  Outcome Measures
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1.  Primary:   Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Primary:   Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months   [ Time Frame: 24 months ]
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3.  Secondary:   Back Pain   [ Time Frame: 7 days, 30 days, 3 months, 12 months, 24 months post-operation ]
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4.  Secondary:   Back Function-Oswestry Disability Index   [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ]
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5.  Secondary:   Quality of Life by SF-36   [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ]
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6.  Secondary:   Quality of Life -- EQ5D Index   [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ]
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7.  Secondary:   Rate of Serious Adverse Events at 30 Days   [ Time Frame: 30 days post-operation ]
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8.  Secondary:   Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days   [ Time Frame: 30 days post-operation ]
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9.  Secondary:   Change in Anterior Vertebral Body Height   [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
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10.  Secondary:   Change in Middle Vertebral Body Height   [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
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11.  Secondary:   Change in Posterior Vertebral Body Height   [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
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12.  Secondary:   Change in Vertebral Body Kyphosis Angle   [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
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13.  Secondary:   Change in Vertebral Body Local Cobb Angle (LCA)   [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
  Show Outcome Measure 13

14.  Secondary:   Change in Global Sagittal Balance.   [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
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15.  Secondary:   VCF-related Health Care Utilization   [ Time Frame: Monthly for 24 months post-op ]
  Show Outcome Measure 15


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
The original study design required n=1,234 randomized patients; however, the study was stopped early with only n=404 enrolled patients, due to low enrollment, difficulty in willingness to randomize patients and a high proportion of early terminations  


Results Point of Contact:  
Name/Title: John Tillman
Organization: Medtronic
phone: 408-548-6518
e-mail: tillmj1@mspexcng.medtronic.com


No publications provided


Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00323609     History of Changes
Other Study ID Numbers: SP0601-KAVIAR
Study First Received: May 5, 2006
Results First Received: June 29, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board