The goal of this observational study is to evaluate patient outcomes following treatment of vertebrogenic low back pain using the Stryker OptaBlate BVN System. Patients treated in accordance with the device IFU as part of routine clinical care and who consent to participate will be followed for 12 months after the procedure to assess treatment outcomes.
Patient scheduled for treatment with the OptaBlate BVN System in accordance with the device IFU and willing to participate in the clinical investigation, undergo study procedure, engage in follow-up, able to read, write, speak, and understand English, and able to provide written informed consent.
The patient meets one or more contraindications as defined in the locally applicable IFU
Spinal fracture or history of spinal trauma at index levels
Previous lumbar fusion at any level
Prior basivertebral nerve ablation at the target levels
Patients with chronic low back pain of at least 6 months' duration that has not responded to at least 6 months of conservative treatment and who demonstrate Type 1 or Type 2 Modic changes on MRI consistent with vertebrogenic pain.
Cohort
Prospective
Basivertebral nerve ablation
DeviceThe basivertebral nerve ablation is a minimally invasive, image-guided procedure in which radiofrequency energy is used to ablate the basivertebral nerve within the vertebral body, interrupting pain signals associated with vertebrogenic low back pain.
Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score
Incidence and severity of adverse events related to the procedure and/or device.
Change in Oswestry Disability Index (ODI) score
Change in Visual Analogue Score (VAS)
Rate of patients achieving clinical success at 3 months, defined as Oswestry Disability Index (ODI) score improvement ≥10 points and VAS reduction ≥2 cm
Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36))
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