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What is the purpose of this study?

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.

Can I participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions: Spinal Fractures, Fractures, Compression
• Age: Between 21 - 100 Years
• Gender: Male or Female
• +

  Inclusion Criteria:

  All subjects must meet all of the following criteria to be enrolled into the study:

  Age > 21

  1 to 3 target VCFs meeting the following criteria:

  Fracture due to diagnosed or presumed underlying primary or secondary

  osteoporosis

  All target VCFs are between T5 and L5

  All target VCFs to be treated show either: i. Height change: An acute (< 6

  month) change in VB height or morphology from a previous x-ray CT or MRI with

  height loss at the anterior middle or posterior portion of the VB consistent

  with a worsening of 1 or more grades by the Genant criteria (17) OR ii. Positive

  MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI or target VB

  is positive on radionuclide bone scan

  All VCFs to be treated have fracture age (time from pain onset to evaluation by

  the Investigator) of 6 months or less

  Back pain correlating with the location of at least one VCF

  Treatment of all target VCFs is technically feasible by and clinically appropriate for

  BOTH vertebroplasty and balloon kyphoplasty. (Team approach only: Both the

  vertebroplasty and balloon kyphoplasty physician have reviewed radiographic studies

  and agree to this prior to enrolling the subject in the study.)

  Pre-treatment back pain by numerical rating scale (NRS) score > 4 (0-10 scale)

  Pre-treatment Oswestry Disability Index >20 (0 - 100 scale)

  Subject states availability for all study visits

  Subject is able to understand the risks and benefits of participating in the study and

  is willing to provide written informed consent

  Subject has mental capacity to comply with the protocol requirements for 2-year

  duration of study
• +

  Exclusion Criteria:

  Subjects who meet any of the following conditions may not be enrolled into the study:

  VB morphology or configuration is such that either balloon kyphoplasty OR

  vertebroplasty is not technically feasible for the targeted VCFs

  Fracture due to high-energy trauma

  Suspected OR proven cancer inside index vertebral body. Note that patients with

  chemotherapy-related osteoporosis may be included.

  Disabling back pain due to causes other than acute fracture (e.g. sacroiliac

  fracture symptomatic degenerative disc disease lumbar spinal stenosis)

  Any painful VCF with fracture age > 6 months

  Any objective evidence of neurologic compromise at baseline

  Previous balloon kyphoplasty or vertebroplasty for any VCF

  Spine stabilization beyond balloon kyphoplasty or vertebroplasty required for targeted

  VCFs

  Significant clinical comorbidity that may potentially interfere with long-term data

  collection or follow-up (e.g. dementia severe comorbid illness)

  Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty such

  as:

  Irreversible coagulopathy or bleeding disorder. Note regarding reversible

  coagulopathies: Subjects on coumadin or other anticoagulants may participate.

  Investigators should follow routine practices for perioperative discontinuation

  and re-initiation of anticoagulants.

  Allergy to any device materials (e.g. bone cement) for balloon kyphoplasty or

  vertebroplasty. Note that in subjects with allergy to iodine-based contrast

  other non-iodine contrast solutions may be used.

  Any evidence of VB or systemic infection

  Pregnant or child-bearing potential

Detail Study Description

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.

Study Treatments

Vertebroplasty, Kyphoplasty, Balloon kyphoplasty

Last Updated: December 2008