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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benvenue Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01123512
First received: May 11, 2010
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Spinal Fractures
Fractures, Compression
Back Injuries
Device: Vertebral augmentation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by Benvenue Medical, Inc.:

Primary Outcome Measures:
  • Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm Visual Analog Scale (VAS) [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: No ]
  • Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bone Cement Volume [ Time Frame: 0 to 14 Days from Baseline ] [ Designated as safety issue: No ]
  • Back pain on Visual Analog Scale (VAS) [ Time Frame: 7 Day Post-op, 30 Day Post-op, 6 Month Post-op, and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Extravasation [ Time Frame: Intra-operative, Post-operative , 30 Day Post-op, 6 Month Post-op, and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Dysfunction on Oswestry Disability Index (ODI) [ Time Frame: 30 Day Post-op, 6 Month Post-op, and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Subsequent Fracture Rate [ Time Frame: Post-operative, 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: Yes ]
  • Adjacent Level Fracture Rate [ Time Frame: Post-operative, 30 Day Post-op, 6 Month Post-op and12 Month Post-op ] [ Designated as safety issue: Yes ]
  • SF-36 Physical and Mental Composite Score [ Time Frame: 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Vertebral Body Height [ Time Frame: Post-operative, 30 Day Post-op, 6 Month Post-op, and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Kyphotic Angle [ Time Frame: Post-operative, 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Ambulatory Status [ Time Frame: 7 Day Post-op, 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Activities of Daily Living Status [ Time Frame: 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 7 Day Post-op, 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Freedom from Narcotic Medication Use [ Time Frame: 7 Day Post-op, 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Discharge, 7 Day Post-op, 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: Yes ]
  • Incidence of Surgical Reinterventions/Retreatment [ Time Frame: Post-operative, 7 Day Post-op, 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: Yes ]
  • Implant or Cement Bolus Migration [ Time Frame: 30 Day Post-op, 6 Month Post-op and 12 Month Post-op ] [ Designated as safety issue: No ]
  • Technical Failure [ Time Frame: 0 to 14 Days from Baseline ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: July 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01123512

  Show 21 Study Locations
Sponsors and Collaborators
Benvenue Medical, Inc.
Investigators
Principal Investigator: Steven Garfin, MD University of California, San Diego, CA
Principal Investigator: Sean Tutton, MD, FSIR Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Benvenue Medical, Inc.
ClinicalTrials.gov Identifier: NCT01123512     History of Changes
Other Study ID Numbers: BEN005
Study First Received: May 11, 2010
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Benvenue Medical, Inc.:
Vertebral Compression Fracture
Kyphoplasty
Spine
Vertebral Body Compression Fracture
Back Pain

Additional relevant MeSH terms:
Back Injuries
Fractures, Bone
Spinal Fractures
Fractures, Compression
Wounds and Injuries
Spinal Injuries

ClinicalTrials.gov processed this record on July 28, 2014