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Recruiting NCT07392333

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

— Observational Verteborgenic Low Back Pain Back Pain Lower Back

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Basivertebral nerve ablation.
Who it may be relevant to
Registry conditions: Verteborgenic Low Back Pain, Back Pain Lower Back. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score [Time frame: 3 months post-procedure]
  • Incidence and severity of adverse events related to the procedure and/or device. [Time frame: 12 months post-procedure]
Secondary outcome measures (9)
  • Change in Oswestry Disability Index (ODI) score [Time frame: 6 and 12 months post-procedure]
  • Change in Visual Analogue Score (VAS) [Time frame: 3, 6 and 12 months post-procedure]
  • Rate of patients achieving clinical success at 3 months, defined as Oswestry Disability Index (ODI) score improvement ≥10 points and VAS reduction ≥2 cm [Time frame: 3 months post-procedure]
  • Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36)) [Time frame: 3, 6, and 12 months post-procedure]
  • Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records [Time frame: 3, 6 and 12 months post-procedure]
  • Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.) [Time frame: 12 months post-procedure]
  • Imaging assessment - Magnetic Resonance Imaging (MRI) including Mean size of the lesion Rate of subjects with radiographic evidence of targeting success based on lesion location on MRI [Time frame: 6 weeks post-procedure]
  • Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)) [Time frame: 3, 6 and 12 months post-procedure]
  • Assessment of global patient satisfaction through completion of a brief, non-validated, rating-scale questionnaire. [Time frame: 3, 6 and 12 months post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cantor Spine Center — Fort Lauderdale

Identifiers

NCT: NCT07392333 · SISBVN12025US

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗