Study Stopped
Due to high number of patients terminating study early, low patient enrollment and difficulty in patient/investigator willingness for randomization
KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures
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).
1 other identifier
interventional
404
2 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2006
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
August 8, 2012
CompletedJanuary 2, 2018
June 1, 2012
4.9 years
May 5, 2006
June 29, 2012
December 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months
12 months
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months
24 months
Secondary Outcomes (13)
Back Pain
7 days, 30 days, 3 months, 12 months, 24 months post-operation
Back Function-Oswestry Disability Index
30 days, 3 months, 12 months, 24 months post-operation
Quality of Life by SF-36
30 days, 3 months, 12 months, 24 months post-operation
Quality of Life -- EQ5D Index
30 days, 3 months, 12 months, 24 months post-operation
Rate of Serious Adverse Events at 30 Days
30 days post-operation
- +8 more secondary outcomes
Study Arms (2)
Kyphoplasty
ACTIVE COMPARATORVertebroplasty
ACTIVE COMPARATORInterventions
Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.
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.
Eligibility Criteria
You may qualify if:
- All subjects must meet all of the following criteria to be enrolled into the study:
- Age \> 21
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Scottsdale Medical Imaging, Ltd
Scottsdale, Arizona, 85252, United States
Minimally Invasive Surgical Solutions
San Jose, California, 95128, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Western Slope Study Group
Grand Junction, Colorado, 81501, United States
The Center for Spinal Disorders
Tampa, Florida, 33637, United States
Radiology Associates of Atlanta
Atlanta, Georgia, 30309, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Northwest Research & Educational Institute
Billings, Montana, 59101, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
University Orthopedics
Rochester, New York, 14642, United States
Atrium Medical Center
Franklin, Ohio, 45005, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Clinical Radiology of Oklahoma
Edmond, Oklahoma, 73003, United States
The Center for Orthopedic and Neurosurgical Care and Research (The Center)
Bend, Oregon, 97701, United States
Reading Hospital
Reading, Pennsylvania, 19601, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033, United States
St. Mary's Hospital
Huntington, West Virginia, 25702, United States
Aurora Burlington Memorial Hospital
Burlington, Wisconsin, 53105, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Royal Victoria Hospital
Barrie, Ontario, L4M6MZ, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The original study design required n=1,234 randomized patients; however, the study was stopped early with only n=404 enrolled patients, due to low enrollment, difficulty in willingness to randomize patients and a high proportion of early terminations
Results Point of Contact
- Title
- John Tillman
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Reginald Knight, MD
Orthopedics International
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2006
First Posted
May 9, 2006
Study Start
August 1, 2006
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
January 2, 2018
Results First Posted
August 8, 2012
Record last verified: 2012-06