Basivertebral nerve ablation: The 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* Vertebral cancer, spinal metastasis or Tumor-related vertebral fractures
* History of Osteoporotic vertebral fractures
* Spine interventions, including epidural steroid injections within 30 days
* BMI \> 40 kg/m²
* Symptomatic spinal stenosis
* Radicular pain or leg pain greater than back pain
* Pregnancy or planning pregnancy during study period
* Enrollment in another interventional clinical trial
* Contraindication to MRI
* Life expectancy of less than 12 months
Primary outcome measure(s)
Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score — 3 months post-procedure
Incidence and severity of adverse events related to the procedure and/or device. — 12 months post-procedure
Trial sites (1)
Facility
City
Region
Status
Cantor Spine Center
Fort Lauderdale
Florida
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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