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.
Study Type
OBSERVATIONAL
Enrollment
25
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.
Cantor Spine Center
Fort Lauderdale, Florida, United States
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
Change in ODI
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 ODI 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
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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
Time frame: 3, 6 and 12 months post-procedure