Vertebral Body Compression FracturesNCT00323609
KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures
A study testing Vertebroplasty and Kyphoplasty in people with Vertebral Body Compression Fractures, run by Medtronic Spine LLC at 26 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Vertebral Body Compression Fractures
- What is being tested?
- Vertebroplasty and Kyphoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Aug 2006to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
Radiology Associates of Atlanta
Atlanta, Georgia, 30309
The Center for Orthopedic and Neurosurgical Care and Research (The Center)
Bend, Oregon, 97701
Northwest Research & Educational Institute
Billings, Montana, 59101
Aurora Burlington Memorial Hospital
Burlington, Wisconsin, 53105
Clinical Radiology of Oklahoma
Edmond, Oklahoma, 73003
Atrium Medical Center
Franklin, Ohio, 45005
Western Slope Study Group
Grand Junction, Colorado, 81501
The Methodist Hospital Research Institute
Houston, Texas, 77030
St. Mary's Hospital
Huntington, West Virginia, 25702
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Intermountain Medical Center
Murray, Utah, 84157
Ochsner Medical Center
New Orleans, Louisiana, 70121
Utah Valley Regional Medical Center
Provo, Utah, 84604
Reading Hospital
Reading, Pennsylvania, 19601
Renown Regional Medical Center
Reno, Nevada, 89502
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
University Orthopedics
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Minimally Invasive Surgical Solutions
San Jose, California, 95128
Scottsdale Medical Imaging, Ltd
Scottsdale, Arizona, 85252
The Center for Spinal Disorders
Tampa, Florida, 33637
Scott & White Memorial Hospital
Temple, Texas, 76508
The Toledo Hospital
Toledo, Ohio, 43606
Torrance Memorial Medical Center
Torrance, California, 90505
About this 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).
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.
Read the 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.
- Conditions
- Vertebral Body Compression Fractures
- Being tested
- Vertebroplasty, Kyphoplasty
- Keywords
- Kyphoplasty, Vertebroplasty, Balloon Kyphoplasty, Inflatable Bone Tamp, Spine, Back Pain, Vertebral Compression Fracture, Vertebral Body Compression Fracture
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyProcedure or surgery
Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.
KyphoplastyProcedure or surgery
Balloon Kyphoplasty involves two inflatable bone tamps placed into the vertebral body in the spine. After the tamps are removed, the void is filled with viscous bone cement.
| Study group | Role | What they receive |
|---|---|---|
| Kyphoplasty | Active comparator | Not described Receives: Procedure: Kyphoplasty |
| Vertebroplasty | Active comparator | Not described Receives: Procedure: Vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months
Measured: 12 months
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months
Measured: 24 months
Secondary outcomes (13)
Back Pain
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Measured: 7 days, 30 days, 3 months, 12 months, 24 months post-operation
Back Function-Oswestry Disability Index
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).
Measured: 30 days, 3 months, 12 months, 24 months post-operation
Quality of Life by SF-36
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.
Measured: 30 days, 3 months, 12 months, 24 months post-operation
Quality of Life -- EQ5D Index
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Measured: 30 days, 3 months, 12 months, 24 months post-operation
Rate of Serious Adverse Events at 30 Days
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.
Measured: 30 days post-operation
Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days
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.
Measured: 30 days post-operation
Change in Anterior Vertebral Body Height
Measured: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Middle Vertebral Body Height
Measured: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Posterior Vertebral Body Height
Measured: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Vertebral Body Kyphosis Angle
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.
Measured: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Vertebral Body Local Cobb Angle (LCA)
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.
Measured: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Global Sagittal Balance.
Change in global sagittal balance as measured by sagittal vertical axis.
Measured: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
VCF-related Health Care Utilization
Health care utilization assessments conducted by monthly phone call to participating patients.
Measured: Monthly for 24 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Due to high number of patients terminating study early, low patient enrollment and difficulty in patient/investigator willingness for randomization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vertebral Body Compression FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spine LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reginald Knight, MD, Principal investigator, Orthopedics International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323609
- Sponsor's protocol ID
- SP0601-KAVIAR
- Status last verified
- Jun 2012
- First submitted
- 5 May 2006
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00323609
- Acronym / sponsor ID
- SP0601-KAVIAR
- Conditions
- Vertebral Body Compression Fractures
- Keywords
- Kyphoplasty, Vertebroplasty, Balloon Kyphoplasty, Inflatable Bone Tamp, Spine, Back Pain, Vertebral Compression Fracture, Vertebral Body Compression Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to high number of patients terminating study early, low patient enrollment and difficulty in patient/investigator willingness for randomization
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Medtronic Spine LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Posted 8 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kyphoplasty | Active comparator | Procedure: Kyphoplasty |
| Vertebroplasty | Active comparator | Procedure: Vertebroplasty |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age > 21
- 1 to 3 target VCFs meeting the following criteria:
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VertebroplastyVertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body. | Procedure or surgery | Vertebroplasty |
| KyphoplastyBalloon Kyphoplasty involves two inflatable bone tamps placed into the vertebral body in the spine. After the tamps are removed, the void is filled with viscous bone cement. | Procedure or surgery | Kyphoplasty |
Primary outcome
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months
Time frame: 12 months
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months
Time frame: 24 months
13 secondary outcomes
Back Pain
Time frame: 7 days, 30 days, 3 months, 12 months, 24 months post-operation
Back Function-Oswestry Disability Index
Time frame: 30 days, 3 months, 12 months, 24 months post-operation
Quality of Life by SF-36
Time frame: 30 days, 3 months, 12 months, 24 months post-operation
Quality of Life -- EQ5D Index
Time frame: 30 days, 3 months, 12 months, 24 months post-operation
Rate of Serious Adverse Events at 30 Days
Time frame: 30 days post-operation
Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days
Time frame: 30 days post-operation
Change in Anterior Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Middle Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Posterior Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Vertebral Body Kyphosis Angle
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Vertebral Body Local Cobb Angle (LCA)
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Global Sagittal Balance.
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
VCF-related Health Care Utilization
Time frame: Monthly for 24 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reginald Knight, MD principal investigator
Orthopedics International
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebroplasty and Kyphoplasty in people with Vertebral Body Compression Fractures, run by Medtronic Spine LLC at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.