A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain

Purpose

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.

Conditions

  • Verteborgenic Low Back Pain
  • Back Pain Lower Back

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
OptaBate BVN cohort
  • Device: 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.

Recruiting Locations

Cantor Spine Center
Fort Lauderdale, Florida 33306
Contact:
Anthony Giuffrida, MD
954-567-1332
info@cantorspinecenter.com

More Details

Status
Recruiting
Sponsor
Stryker Instruments

Study Contact