Status:
TERMINATED
KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures
Lead Sponsor:
Medtronic Spine LLC
Conditions:
Vertebral Body Compression Fractures
Eligibility:
All Genders
21+ years
Phase:
NA
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, ...
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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00323609
Start Date
August 1 2006
End Date
July 1 2011
Last Update
January 2 2018
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Scottsdale Medical Imaging, Ltd
Scottsdale, Arizona, United States, 85252
2
Minimally Invasive Surgical Solutions
San Jose, California, United States, 95128
3
Torrance Memorial Medical Center
Torrance, California, United States, 90505
4
Western Slope Study Group
Grand Junction, Colorado, United States, 81501