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Sponsored by: |
Medtronic Spine LLC |
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Information provided by: | Medtronic Spine LLC |
ClinicalTrials.gov Identifier: | NCT00323609 |
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.
Condition | Intervention | Phase |
---|---|---|
Spinal Fractures Fractures, Compression |
Procedure: Vertebroplasty Procedure: Kyphoplasty Device: Balloon Kyphoplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 Osteoporosis-Related Vertebral Body Compression Fractures (VCFs). |
Estimated Enrollment: | 1234 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2011 |
Kyphon Inc. 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 24 months.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
All subjects must meet all of the following criteria to be enrolled into the study:
1 to 3 target VCFs meeting the following criteria:
Exclusion Criteria
Subjects who meet any of the following conditions may not be enrolled into the study:
Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as:
Contact: Van Weiss | (408)548-5494 | Van.V.Weiss@Medtronic.com |
Contact: Talat Ashraf, MD | (408)548-6512 | Talat.Ashraf@Medtronic.com |
Principal Investigator: | Reginald Knight, MD | Orthopedics International |
Study ID Numbers: | SP0601-KAVIAR |
Study First Received: | May 5, 2006 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00323609 History of Changes |
Health Authority: | United States: Institutional Review Board |
Kyphoplasty Vertebroplasty Balloon Kyphoplasty Inflatable Bone Tamp |
Spine Back Pain Vertebral Compression Fracture Vertebral Body Compression Fracture |
Fractures, Compression Spinal Injuries Fractures, Bone Back Injuries Wounds and Injuries |
Spinal Fractures Disorders of Environmental Origin Osteoporosis Pain Back Pain |
Fractures, Compression Spinal Injuries Fractures, Bone Back Injuries |
Wounds and Injuries Spinal Fractures Disorders of Environmental Origin |