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

Stopped early · Not applicable

Conditions studied: Vertebral Body Compression Fractures

In brief

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.

Key facts

Study ID

NCT00323609

Run by

Medtronic Spine LLC

People needed

404

Starts

2006-08-01

Expected to finish

2011-07-01

Last updated by the study team

2018-01-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• Scottsdale Medical Imaging, Ltd — Scottsdale, Arizona, United States
• Minimally Invasive Surgical Solutions — San Jose, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Western Slope Study Group — Grand Junction, Colorado, United States
• The Center for Spinal Disorders — Tampa, Florida, United States
• Radiology Associates of Atlanta — Atlanta, Georgia, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Northwest Research & Educational Institute — Billings, Montana, United States
• Renown Regional Medical Center — Reno, Nevada, United States
• University Orthopedics — Rochester, New York, United States
• Atrium Medical Center — Franklin, Ohio, United States
• The Toledo Hospital — Toledo, Ohio, United States
• Clinical Radiology of Oklahoma — Edmond, Oklahoma, United States
• The Center for Orthopedic and Neurosurgical Care and Research (The Center) — Bend, Oregon, United States
• Reading Hospital — Reading, Pennsylvania, United States
• The Methodist Hospital Research Institute — Houston, Texas, United States
• Scott & White Memorial Hospital — Temple, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• Utah Valley Regional Medical Center — Provo, Utah, United States
• Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States
• St. Mary's Hospital — Huntington, West Virginia, United States
• Aurora Burlington Memorial Hospital — Burlington, Wisconsin, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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