Back Injuries, Fractures, Compression, Spinal Fractures
Conditions
Keywords
Vertebral Compression Fracture, Kyphoplasty, Spine, Vertebral Body Compression Fracture, Back Pain
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.
Interventions
DEVICEVertebral augmentation
Vertebral augmentation for one or two osteoporotic vertebral compression fractures
Sponsors
Benvenue Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Study Success | 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 |
Countries
Belgium, Canada, France, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kiva VCF Treatment System The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant. | 144 |
| Balloon Kyphoplasty The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA. | 141 |
| Total | 285 |
Baseline characteristics
| Characteristic | Balloon Kyphoplasty | Total | Kiva VCF Treatment System |
|---|---|---|---|
| Age, Continuous | 75.09 years STANDARD_DEVIATION 9.62 | 75.57 years STANDARD_DEVIATION 9.22 | 76.03 years STANDARD_DEVIATION 8.82 |
| Sex: Female, Male Female | 106 Participants | 211 Participants | 105 Participants |
| Sex: Female, Male Male | 35 Participants | 74 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 81 / 153 | 80 / 147 |
| serious Total, serious adverse events | 44 / 153 | 51 / 147 |
Outcome results
Primary
Proportion of Participants With Study Success
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
Time frame: 12 Month Post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kiva VCF Treatment System | Proportion of Participants With Study Success | 120 participants |
| Balloon Kyphoplasty | Proportion of Participants With Study Success | 123 participants |
Bayesian test of proportions