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

The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial

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.

Study Overview

• Status: Completed
• Conditions: Spinal Fractures; Back Injuries; Fractures, Compression
• Intervention / Treatment: Device: Vertebral augmentation

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium
    • CHC Saint Joseph
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
• France
  • Amiens, France, 80054
    • CHU Amiens Sud
• Germany
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Potsdam, Germany
    • Klinikum Ernst von Bergmann gGmbH
• United States
  • California
    • Encinitas, California, United States, 92021
      • CORE Orthopaedic Medical Center
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Sacramento, California, United States, 95816
      • Radiological Associates of Sacramento
    • San Francisco, California, United States, 94117
      • St. Mary's Spine Center
  • Colorado
    • Englewood, Colorado, United States, 80112
      • Radiology Imaging Associates
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Hospital
    • Hinsdale, Illinois, United States, 60521
      • Adventist Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic-Rochester
  • Nevada
    • Reno, Nevada, United States, 89509
      • Sierra Regional Spine Institute
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Clinical Radiology of Oklahoma
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Study Success	Patient success will be defined as: Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),; Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and; 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	12 Month Post-op

Collaborators and Investigators

• Sponsor: Benvenue Medical, Inc.
• Investigators: Principal Investigator: Steven R. Garfin, MD, University of California, San Diego, CA; Principal Investigator: Sean M. Tutton, MD, FSIR, Medical College of Wisconsin

Publications and helpful links

General Publications

• Beall DP, Coe JD, McIlduff M, Bloch D, Hornberger J, Warner C, Tutton S. Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty. Pain Physician. 2017 Sep;20(6):521-528.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 1, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Back Pain; Spine; Kyphoplasty; Vertebral Compression Fracture; Vertebral Body Compression Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Fractures, Bone; Spinal Fractures; Fractures, Compression; Back Injuries
• Other Study ID Numbers: BEN005