The Kiva® System as a Vertebral Augmentation Treatment
Condition: Spinal Fractures; Fractures, Compression; Back Injuries
MeSH terms: Fractures, Bone; Spinal Fractures; Back Injuries; Fractures, Compression
Intervention: Vertebral augmentation
Intervention description: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 300.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Vertebral Compression Fracture; Kyphoplasty; Spine; Vertebral Body Compression Fracture; Back Pain

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