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

December 6, 2017 updated by: Medtronic Spine LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M6MZ
        • Royal Victoria Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85252
        • Scottsdale Medical Imaging, Ltd
    • California
      • San Jose, California, United States, 95128
        • Minimally Invasive Surgical Solutions
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Western Slope Study Group
    • Florida
      • Tampa, Florida, United States, 33637
        • The Center for Spinal Disorders
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Radiology Associates of Atlanta
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
    • Montana
      • Billings, Montana, United States, 59101
        • Northwest Research & Educational Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New York
      • Rochester, New York, United States, 14642
        • University Orthopedics
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Atrium Medical Center
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital
    • Oklahoma
      • Edmond, Oklahoma, United States, 73003
        • Clinical Radiology of Oklahoma
    • Oregon
      • Bend, Oregon, United States, 97701
        • The Center for Orthopedic and Neurosurgical Care and Research (The Center)
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19601
        • Reading Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
    • Virginia
      • Roanoke, Virginia, United States, 24033
        • Carilion Roanoke Memorial Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Hospital
    • Wisconsin
      • Burlington, Wisconsin, United States, 53105
        • Aurora Burlington Memorial Hospital
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Kyphoplasty
Procedure: Kyphoplasty
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.
Active Comparator: Vertebroplasty
Procedure: Vertebroplasty
Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months
Time Frame: 12 months
12 months
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Back Pain
Time Frame: 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).
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
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).
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
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.
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
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
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 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.
30 days post-operation
Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days
Time Frame: 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.
30 days post-operation
Change in Anterior Vertebral Body Height
Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
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
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
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
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.
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
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.
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
Change in global sagittal balance as measured by sagittal vertical axis.
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
Health care utilization assessments conducted by monthly phone call to participating patients.
Monthly for 24 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Spine LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reginald Knight, MD, Orthopedics International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP0601-KAVIAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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