About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Basivertebral nerve ablation