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

Not Applicable

Terminated

Conditions: Vertebral Body Compression Fractures

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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
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.
Change in Anterior Vertebral Body Height	Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation

Trial Locations

Locations (26): Scottsdale Medical Imaging, Ltd
🇺🇸
Scottsdale, Arizona, United States
Minimally Invasive Surgical Solutions
🇺🇸
San Jose, California, United States
Torrance Memorial Medical Center
🇺🇸
Torrance, California, United States
Western Slope Study Group
🇺🇸
Grand Junction, Colorado, United States
The Center for Spinal Disorders
🇺🇸
Tampa, Florida, United States
Radiology Associates of Atlanta
🇺🇸
Atlanta, Georgia, United States
Ochsner Medical Center
🇺🇸
New Orleans, Louisiana, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Saint Luke's Hospital of Kansas City
🇺🇸
Kansas City, Missouri, United States
Northwest Research & Educational Institute
🇺🇸
Billings, Montana, United States
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Scottsdale Medical Imaging, Ltd
🇺🇸Scottsdale, Arizona, United States