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

• ClinicalTrials.gov Identifier: NCT01123512
• Recruitment Status: Completed
• First Posted: May 14, 2010
• Results First Posted: August 21, 2014
• Last Update Posted: October 9, 2014
• Sponsor: Benvenue Medical, Inc.
• Information provided by (Responsible Party): Benvenue Medical, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

CORE Orthopaedic Medical Center

Encinitas, California, United States, 92021

El Camino Hospital

Mountain View, California, United States, 94040

Radiological Associates of Sacramento

Sacramento, California, United States, 95816

St. Mary's Spine Center

San Francisco, California, United States, 94117

United States, Colorado

Radiology Imaging Associates

Englewood, Colorado, United States, 80112

United States, Florida

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

United States, Illinois

Evanston Hospital

Evanston, Illinois, United States, 60201

Adventist Hospital

Hinsdale, Illinois, United States, 60521

United States, Louisiana

Spine Institute of Louisiana

Shreveport, Louisiana, United States, 71101

United States, Minnesota

Mayo Clinic-Rochester

Rochester, Minnesota, United States, 55905

United States, Nevada

Sierra Regional Spine Institute

Reno, Nevada, United States, 89509

United States, Oklahoma

Clinical Radiology of Oklahoma

Edmond, Oklahoma, United States, 73013

United States, Pennsylvania

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Belgium

CHC Saint Joseph

Liege, Belgium

Canada, Ontario

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Canada, Quebec

Montreal General Hospital

Montreal, Quebec, Canada, H3G 1A4

France

CHU Amiens Sud

Amiens, France, 80054

Germany

Universitatsklinikum Bonn

Bonn, Germany

Klinikum Ernst von Bergmann gGmbH

Potsdam, Germany

Sponsors and Collaborators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Benvenue Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01123512
• Other Study ID Numbers: BEN005
• First Posted: May 14, 2010
• 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; Kyphoplasty; Spine; Vertebral Body Compression Fracture; Back Pain

Additional relevant MeSH terms:

Fractures, Bone; Spinal Fractures; Back Injuries; Fractures, Compression; Wounds and Injuries; Spinal Injuries