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

Purpose

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.

Condition	Intervention	Phase
Vertebral Body Compression Fractures	Procedure: Vertebroplasty Procedure: Kyphoplasty	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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).

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Fractures

U.S. FDA Resources

Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:

Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Back Pain [ Time Frame: 7 days, 30 days, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Back Function-Oswestry Disability Index [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
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).
Quality of Life by SF-36 [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
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.
Quality of Life -- EQ5D Index [ Time Frame: 30 days, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Rate of Serious Adverse Events at 30 Days [ Time Frame: 30 days post-operation ] [ Designated as safety issue: Yes ]
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.
Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days [ Time Frame: 30 days post-operation ] [ Designated as safety issue: Yes ]
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.
Change in Anterior Vertebral Body Height [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
Change in Middle Vertebral Body Height [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
Change in Posterior Vertebral Body Height [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
Change in Vertebral Body Kyphosis Angle [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
Change in Vertebral Body Local Cobb Angle (LCA) [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
Change in Global Sagittal Balance. [ Time Frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation ] [ Designated as safety issue: No ]
Change in global sagittal balance as measured by sagittal vertical axis.
VCF-related Health Care Utilization [ Time Frame: Monthly for 24 months post-op ] [ Designated as safety issue: No ]
Health care utilization assessments conducted by monthly phone call to participating patients.


Enrollment:	404
Study Start Date:	August 2006
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:
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
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:
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
Pregnant or child-bearing potential

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323609

Show 26 Study Locations

Sponsors and Collaborators

Medtronic Spine LLC

Investigators


Principal Investigator:	Reginald Knight, MD	Orthopedics International

More Information


Responsible Party:	Medtronic Spine LLC
ClinicalTrials.gov Identifier:	NCT00323609 History of Changes
Other Study ID Numbers:	SP0601-KAVIAR
Study First Received:	May 5, 2006
Results First Received:	June 29, 2012
Last Updated:	March 18, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Spine LLC:


Kyphoplasty Vertebroplasty Balloon Kyphoplasty Inflatable Bone Tamp	Spine Back Pain Vertebral Compression Fracture Vertebral Body Compression Fracture

Additional relevant MeSH terms:


Fractures, Bone Fractures, Compression Wounds and Injuries

ClinicalTrials.gov processed this record on September 28, 2016