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

NCT ID: NCT00323609

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Vertebral Body Compression Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Kyphoplasty

Group Type: ACTIVE_COMPARATOR

Kyphoplasty

Intervention Type: PROCEDURE

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.

Vertebroplasty

Group Type: ACTIVE_COMPARATOR

Vertebroplasty

Intervention Type: PROCEDURE

Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.

Interventions

Vertebroplasty

Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spine LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reginald Knight, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedics International

Locations

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

Royal Victoria Hospital

Barrie, Ontario, Canada

Countries

United States; Canada

Other Identifiers

SP0601-KAVIAR

Identifier Type: -

Identifier Source: org_study_id