Clinical trial NCT01123512: The Kiva® System as a Vertebral Augmentation Treatment
Official title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Fractures
Fractures, Compression
Back Injuries
Keywords: Vertebral Compression Fracture
Kyphoplasty
Spine
Vertebral Body Compression Fracture
Back Pain
Lead sponsor: Benvenue Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of Participants With Study Success
timeFrame: 12 Month Post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: CORE Orthopaedic Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento
state: California
city: San Francisco
country: United States
facility: St. Mary's Spine Center
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Hinsdale
country: United States
facility: Adventist Hospital
state: Illinois
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: Reno
country: United States
facility: Sierra Regional Spine Institute
state: Nevada
city: Edmond
country: United States
facility: Clinical Radiology of Oklahoma
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Liege
country: Belgium
facility: CHC Saint Joseph
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Amiens
country: France
facility: CHU Amiens Sud
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH
Study officials:
affiliation: University of California, San Diego, CA
name: Steven R. Garfin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Sean M. Tutton, MD, FSIR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.