The Kiva® System as a Vertebral Augmentation Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Fractures, Fractures, Compression, Back Injuries

Intervention / Treatment
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* Device: Vertebral augmentation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kiva VCF Treatment System<br> | Device: Vertebral augmentation<br>* Vertebral augmentation for one or two osteoporotic vertebral compression fractures<br>|
| Active Comparator: Balloon Kyphoplasty<br> | Device: Vertebral augmentation<br>* Vertebral augmentation for one or two osteoporotic vertebral compression fractures<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral Compression Fracture, Kyphoplasty, Spine, Vertebral Body Compression Fracture, Back Pain