KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures
- Conditions
- Vertebral Body Compression Fractures
- Interventions
- Procedure: VertebroplastyProcedure: Kyphoplasty
- Registration Number
- NCT00323609
- Lead Sponsor
- Medtronic Spine LLC
- 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 Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 404
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vertebroplasty Vertebroplasty - Kyphoplasty Kyphoplasty -
- Primary Outcome Measures
Name Time Method Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months 12 months Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months 24 months
- Secondary Outcome Measures
Name Time Method Change in Anterior Vertebral Body Height Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation Quality of Life by SF-36 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.
Change in Vertebral Body Kyphosis Angle 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.
Back Function-Oswestry Disability Index 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).
Back Pain 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).
Quality of Life -- EQ5D Index 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.
Change in Middle Vertebral Body Height Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation Change in Posterior Vertebral Body Height Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation Change in Global Sagittal Balance. Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation Change in global sagittal balance as measured by sagittal vertical axis.
Rate of Serious Adverse Events at 30 Days 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 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 Vertebral Body Local Cobb Angle (LCA) 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.
VCF-related Health Care Utilization Monthly for 24 months post-op Health care utilization assessments conducted by monthly phone call to participating patients.
Trial Locations
- Locations (26)
Utah Valley Regional Medical Center
🇺🇸Provo, Utah, United States
The Center for Orthopedic and Neurosurgical Care and Research (The Center)
🇺🇸Bend, Oregon, United States
Western Slope Study Group
🇺🇸Grand Junction, Colorado, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Scottsdale Medical Imaging, Ltd
🇺🇸Scottsdale, Arizona, United States
Northwest Research & Educational Institute
🇺🇸Billings, Montana, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
Aurora Burlington Memorial Hospital
🇺🇸Burlington, Wisconsin, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Radiology Associates of Atlanta
🇺🇸Atlanta, Georgia, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Reading Hospital
🇺🇸Reading, Pennsylvania, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Royal Victoria Hospital
🇨🇦Barrie, Ontario, Canada
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
St. Mary's Hospital
🇺🇸Huntington, West Virginia, United States
Atrium Medical Center
🇺🇸Franklin, Ohio, United States
The Center for Spinal Disorders
🇺🇸Tampa, Florida, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
University Orthopedics
🇺🇸Rochester, New York, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Minimally Invasive Surgical Solutions
🇺🇸San Jose, California, United States
Clinical Radiology of Oklahoma
🇺🇸Edmond, Oklahoma, United States