The Kiva® System as a Vertebral Augmentation Treatment

Inclusion criteria

Patients must meet all of the following inclusion criteria below to be included as research subjects:

• The patient is at least 50 years of age
• 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
• The patient has an Oswestry Disability Index (ODI) score of ≥ 30%
• 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
• The patient has central pain over the spinous process(es) upon palpation at the Index level(s)
• 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
• The Index fracture(s) has / have failed conservative care of at least 2 weeks but no longer than 6 months
• The Index fracture(s) shows radiographic evidence of at least 5% vertebral collapse
• The pedicle identified for access to the index fracture has a diameter that is ≥ 6 mm
• 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
• 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:

• The index fracture(s) has/have been caused by high-energy trauma
• The index fracture(s) has / have known tumor involvement
• The index fracture(s) is/are diagnosed as an osteonecrotic fracture(s) by the treating physician
• The Index fracture(s) is a/are translational force fracture(s) (A2.1, 2.2, 2.3)
• 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
• The index fracture(s) has / have posterior vertebral wall displacement occupying more than 20% of the cross sectional area of the spinal canal
• The index fracture(s) has / have severe deformity with reduction of >75% in any height and accompanying area, using adjacent level as comparison
• 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)
• Angulation of index fracture(s) makes treatment with Kiva System impossible (at discretion of surgeon)
• The pedicle identified for access to the index fracture has a diameter less than 6 mm
• The patient has Paget's disease
• The patient has a BMI > 35
• The patient has uncontrolled diabetes as characterized by hemoglobin HbA1c >7% and/or blood sugar >180mg/dL
• The patient has severe cardiopulmonary deficiencies
• The patient has myelopathy
• The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
• 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)
• The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level(s) to be treated;
• The patient has neurologic symptoms or deficits or radiculopathy related to the VCF
• The patient has pain based on clinical diagnosis of herniated nucleus palposus or severe spinal stenosis (progressive weakness or paralysis)
• 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)
• The patient has planned spine surgery for any disorder during or up to 30 days after the study treatment
• The patient has had spine surgery for any disorder in the 30 days prior to enrollment
• 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
• The patient has a known allergy to the investigational device materials and / or acrylics / polymethylmethacrylate (PMMA) or a hypersensitivity to monomers
• The patient has been diagnosed with hemorrhagic diathesis
• The patient has uncontrolled psychiatric illness or severe dementia
• 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
• The patient has a baseline Oswestry Disability Index (ODI) score of <30%
• The patient is currently on anti-cancer therapy or anti-HIV therapy
• Patient has autoimmune or inflammatory rheumatic disease
• Patient's life expectancy is less than the study duration or undergoing palliative care
• The patient is known to be a current alcohol or drug abuser
• The patient is known to be involved in medical litigation including Workmen's Compensation
• The patient is a prisoner
• The patient is participating in another investigational study that has a potential for effect to the study treatment or the study endpoints
• The patient is pregnant or considering getting pregnant during study participation