Clinical trial NCT00323609: KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures
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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vertebral Body Compression Fractures
Keywords: Kyphoplasty
Vertebroplasty
Balloon Kyphoplasty
Inflatable Bone Tamp
Spine
Back Pain
Vertebral Compression Fracture
Vertebral Body Compression Fracture
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 404
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria

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

1. Age \> 21
2. 1 to 3 target VCFs meeting the following criteria:

   1. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis
   2. All target VCFs are between T5 and L5
   3. 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
   4. All VCFs to be treated have fracture age (time from pain onset to evaluation by the Investigator) of 6 months or less
   5. Back pain correlating with the location of at least one VCF
3. 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.)
4. Pre-treatment back pain by numerical rating scale (NRS) score \> 4 (0-10 scale)
5. Pre-treatment Oswestry Disability Index \>20 (0 - 100 scale)
6. Subject states availability for all study visits
7. Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
8. 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:

1. VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs
2. Fracture due to high-energy trauma
3. Suspected OR proven cancer inside index vertebral body. Note that patients with chemotherapy-related osteoporosis may be included.
4. Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)
5. Any painful VCF with fracture age \> 6 months
6. Any objective evidence of neurologic compromise at baseline
7. Previous balloon kyphoplasty or vertebroplasty for any VCF
8. Spine stabilization beyond balloon kyphoplasty or vertebroplasty required for targeted VCFs
9. Significant clinical comorbidity that may potentially interfere with long-term data collection or follow-up (e.g., dementia, severe comorbid illness)
10. Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as:

    1. 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.
    2. 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.
    3. Any evidence of VB or systemic infection
11. Pregnant or child-bearing potential

Primary outcomes:
measure: Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months
timeFrame: 12 months
measure: Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months
timeFrame: 24 months
Secondary outcomes:
measure: Back Pain
timeFrame: 7 days, 30 days, 3 months, 12 months, 24 months post-operation
measure: Back Function-Oswestry Disability Index
timeFrame: 30 days, 3 months, 12 months, 24 months post-operation
measure: Quality of Life by SF-36
timeFrame: 30 days, 3 months, 12 months, 24 months post-operation
measure: Quality of Life -- EQ5D Index
timeFrame: 30 days, 3 months, 12 months, 24 months post-operation
measure: Rate of Serious Adverse Events at 30 Days
timeFrame: 30 days post-operation
measure: Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days
timeFrame: 30 days post-operation
measure: Change in Anterior Vertebral Body Height
timeFrame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
measure: Change in Middle Vertebral Body Height
timeFrame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
measure: Change in Posterior Vertebral Body Height
timeFrame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
measure: Change in Vertebral Body Kyphosis Angle
timeFrame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
measure: Change in Vertebral Body Local Cobb Angle (LCA)
timeFrame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
measure: Change in Global Sagittal Balance.
timeFrame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
measure: VCF-related Health Care Utilization
timeFrame: Monthly for 24 months post-op
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Ltd
state: Arizona
city: San Jose
country: United States
facility: Minimally Invasive Surgical Solutions
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Grand Junction
country: United States
facility: Western Slope Study Group
state: Colorado
city: Tampa
country: United States
facility: The Center for Spinal Disorders
state: Florida
city: Atlanta
country: United States
facility: Radiology Associates of Atlanta
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Billings
country: United States
facility: Northwest Research & Educational Institute
state: Montana
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Rochester
country: United States
facility: University Orthopedics
state: New York
city: Franklin
country: United States
facility: Atrium Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Edmond
country: United States
facility: Clinical Radiology of Oklahoma
state: Oklahoma
city: Bend
country: United States
facility: The Center for Orthopedic and Neurosurgical Care and Research (The Center)
state: Oregon
city: Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Provo
country: United States
facility: Utah Valley Regional Medical Center
state: Utah
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Huntington
country: United States
facility: St. Mary's Hospital
state: West Virginia
city: Burlington
country: United States
facility: Aurora Burlington Memorial Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
Study officials:
affiliation: Orthopedics International
name: Reginald Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: