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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multicenter, Randomized, Prospective Clinical Trial to Compare the Short- and Long-term Safety and Effectiveness of Balloon Kyphoplasty to Vertebroplasty in the Treatment of Painful, Acute Osteoporo

Brief Summary: Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain, back function, quality of life, adverse events, subsequent fractures and cumulative healthcare costs will be compared.

Detailed Summary: Medtronic Spine LLC is sponsoring the KAVIAR study, a randomized clinical trial comparing balloon kyphoplasty to vertebroplasty for the treatment of osteoporotic vertebral body compression fractures (VCFs). Up to 1,234 subjects at up to 75 study centers with one to three VCFs and VB morphologies suitable for both balloon kyphoplasty and vertebroplasty will be randomly assigned to receive one or the other procedure. Study visits will occur at baseline, 30 days postoperatively, and at 3, 12 and 24 months postoperatively. At all visits, adverse events, back pain, back function and quality of life will be assessed. In addition, a 7-day phone call will be conducted, which will include assessment of back pain, narcotic use and adverse events. At baseline, pre-discharge, 3-, 12- and 24-month visits, lateral spine x-rays will be taken. The primary endpoint will be the proportion of patients with one or more subsequent fractures at 12 and 24 months, detected radiographically as determined by a core radiology laboratory. Secondary clinical endpoints include changes from baseline in back pain, back function and quality of life, and adverse events. Secondary radiographic comparisons include the restoration and maintenance of VB height and angulation, and sagittal vertical axis, a measure of global sagittal balance. A postoperative CT scan will be evaluated to detect cement extravasation and to examine the relationship between cement distribution and clinical outcomes. Another important feature of the study is a detailed healthcare utilization data assessment. Combined with a costing methodology based on Medicare cost data and other sources, cumulative two-year healthcare costs related to VCF will be estimated. Combined with quality of life measurements, the cost analysis will allow a calculation of the relative cost-effectiveness of balloon kyphoplasty and vertebroplasty. Sample size is based on the primary endpoint, the proportion with subsequent fractures at 12 and 24 months.
Sponsor: Medtronic Spine LLC

Current Primary Outcome:

  • Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months [ Time Frame: 12 months ]
  • Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months [ Time Frame: 24 months ]


Original Primary Outcome:

  • Serious adverse events
  • Change in back pain as measured by a 10-point numerical rating scale (NRS) and by analgesics used
  • Back function as measured by Oswestry Disability Index
  • Physical function and quality of life as measured by SF-36, the Quality of Life Questionnaire (mini-OQLQ), ambulatory status, and body mass index (BMI)
  • Proportion with subsequent fracture
  • Total number of subsequent fractures (including both symptomatic and asymptomatic)
  • Change in vertebral body height and angulation
  • Change in sagittal vertical axis
  • VCF-related health care utilization.


Current Secondary Outcome:

  • Back Pain [ Time Frame: 7 days, 30 days, 3 months, 12 months, 24 months post-operation ]
    Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
  • Back Function-Oswestry Disability Index [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ]
    The Oswestry Disability Index (ODI) Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
  • Quality of Life by SF-36 [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.
  • Quality of Life -- EQ5D Index [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ]
    EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
  • Rate of Serious Adverse Events at 30 Days [ Time Frame: 30 days post-operation ]
    Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
  • Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days [ Time Frame: 30 days post-operation ]
    Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.
  • Change in Anterior Vertebral Body Height [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
  • Change in Middle Vertebral Body Height [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
  • Change in Posterior Vertebral Body Height [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
  • Change in Vertebral Body Kyphosis Angle [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
    The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body.
  • Change in Vertebral Body Local Cobb Angle (LCA) [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
    The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body.
  • Change in Global Sagittal Balance. [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ]
    Change in global sagittal balance as measured by sagittal vertical axis.
  • VCF-related Health Care Utilization [ Time Frame: Monthly for 24 months post-op ]
    Health care utilization assessments conducted by monthly phone call to participating patients.


Original Secondary Outcome:

Information By: Medtronic Spine LLC

Dates:
Date Received: May 5, 2006
Date Started: August 2006
Date Completion:
Last Updated: March 24, 2017
Last Verified: June 2012