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The Kiva® System as a Vertebral Augmentation Treatment (KAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01123512
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : August 21, 2014
Last Update Posted : October 9, 2014
Information provided by (Responsible Party):
Benvenue Medical, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.

Condition or disease Intervention/treatment Phase
Spinal Fractures Fractures, Compression Back Injuries Device: Vertebral augmentation Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial
Study Start Date : July 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Kiva VCF Treatment System Device: Vertebral augmentation
Vertebral augmentation for one or two osteoporotic vertebral compression fractures

Active Comparator: Balloon Kyphoplasty Device: Vertebral augmentation
Vertebral augmentation for one or two osteoporotic vertebral compression fractures

Primary Outcome Measures :
  1. Proportion of Participants With Study Success [ Time Frame: 12 Month Post-op ]

    Patient success will be defined as:

    1. Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),
    2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and
    3. Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must meet all of the following inclusion criteria below to be included as research subjects:

  1. The patient is at least 50 years of age
  2. The patient has a score on the back pain visual analog scale (VAS) of ≥70 mm after 2 to 6 weeks of conservative care OR a VAS of ≥ 50 mm after 6 weeks of conservative care
  3. The patient has an Oswestry Disability Index (ODI) score of ≥ 30%
  4. The patient has radiographic evidence of one or two (1-2) A 1.1, A 1.2, A 1.3. fractures as classified by the AO Spine Fracture classification, due to primary or secondary osteoporosis in the thoracic and / or lumbar spine. Note that patients are eligible if they have had treatment of or healed VCF(s) at any non-index level
  5. The patient has central pain over the spinous process(es) upon palpation at the Index level(s)
  6. The Index fracture(s) is / are acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI (or bone scan if patient is contraindicated for MRI
  7. The Index fracture(s) has / have failed conservative care of at least 2 weeks but no longer than 6 months
  8. The Index fracture(s) shows radiographic evidence of at least 5% vertebral collapse
  9. The pedicle identified for access to the index fracture has a diameter that is ≥ 6 mm
  10. The patient is mentally capable and willing to sign a study-specific informed consent as documentation of the informed consent process prior to any study procedures
  11. The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments

Exclusion Criteria

Patients will not be allowed to participate in the study if they meet any of the exclusion criteria below:

  1. The index fracture(s) has/have been caused by high-energy trauma
  2. The index fracture(s) has / have known tumor involvement
  3. The index fracture(s) is/are diagnosed as an osteonecrotic fracture(s) by the treating physician
  4. The Index fracture(s) is a/are translational force fracture(s) (A2.1, 2.2, 2.3)
  5. The index fracture(s) is a/are burst fracture(s) (A 3.3., B or C type) or pedicle fracture(s) with posterior cortical wall disruption
  6. The index fracture(s) has / have posterior vertebral wall displacement occupying more than 20% of the cross sectional area of the spinal canal
  7. The index fracture(s) has / have severe deformity with reduction of >75% in any height and accompanying area, using adjacent level as comparison
  8. The index level(s) has / have undergone previous surgical treatment for a vertebral body compression fracture or other surgical procedure at the index level(s)
  9. Angulation of index fracture(s) makes treatment with Kiva System impossible (at discretion of surgeon)
  10. The pedicle identified for access to the index fracture has a diameter less than 6 mm
  11. The patient has Paget's disease
  12. The patient has a BMI > 35
  13. The patient has uncontrolled diabetes as characterized by hemoglobin HbA1c >7% and/or blood sugar >180mg/dL
  14. The patient has severe cardiopulmonary deficiencies
  15. The patient has myelopathy
  16. The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
  17. A medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy (with a threshold for normal being INR ≤ 1.5, PTT within lab normal range, and platelet count > 100,000)
  18. The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level(s) to be treated;
  19. The patient has neurologic symptoms or deficits or radiculopathy related to the VCF
  20. The patient has pain based on clinical diagnosis of herniated nucleus palposus or severe spinal stenosis (progressive weakness or paralysis)
  21. The patient has indications of instability related to the index fracture (≥ 30 degrees of kyphosis, translation >4mm, interspinous process widening, > Grade 1 spondylolisthesis and/or > 25 degrees of scoliosis if the index level is included in the curve)
  22. The patient has planned spine surgery for any disorder during or up to 30 days after the study treatment
  23. The patient has had spine surgery for any disorder in the 30 days prior to enrollment
  24. The patient has a documented active systemic or local infection, such as osteomyelitis or discitis, with a WBC > 15.0 x 10^3/µL and a temperature > 101.5°F
  25. The patient has a known allergy to the investigational device materials and / or acrylics / polymethylmethacrylate (PMMA) or a hypersensitivity to monomers
  26. The patient has been diagnosed with hemorrhagic diathesis
  27. The patient has uncontrolled psychiatric illness or severe dementia
  28. The patient has a baseline back pain visual analog scale (VAS) of <50 mm if patient has at least 6 weeks of conservative care or <70 mm if patient has 2-6 weeks conservative care
  29. The patient has a baseline Oswestry Disability Index (ODI) score of <30%
  30. The patient is currently on anti-cancer therapy or anti-HIV therapy
  31. Patient has autoimmune or inflammatory rheumatic disease
  32. Patient's life expectancy is less than the study duration or undergoing palliative care
  33. The patient is known to be a current alcohol or drug abuser
  34. The patient is known to be involved in medical litigation including Workmen's Compensation
  35. The patient is a prisoner
  36. The patient is participating in another investigational study that has a potential for effect to the study treatment or the study endpoints
  37. The patient is pregnant or considering getting pregnant during study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123512

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Sponsors and Collaborators
Benvenue Medical, Inc.
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Principal Investigator: Steven R. Garfin, MD University of California, San Diego, CA
Principal Investigator: Sean M. Tutton, MD, FSIR Medical College of Wisconsin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benvenue Medical, Inc.
ClinicalTrials.gov Identifier: NCT01123512    
Other Study ID Numbers: BEN005
First Posted: May 14, 2010    Key Record Dates
Results First Posted: August 21, 2014
Last Update Posted: October 9, 2014
Last Verified: October 2014
Keywords provided by Benvenue Medical, Inc.:
Vertebral Compression Fracture
Vertebral Body Compression Fracture
Back Pain
Additional relevant MeSH terms:
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Fractures, Bone
Spinal Fractures
Back Injuries
Fractures, Compression
Wounds and Injuries
Spinal Injuries