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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OptaBate BVN cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basivertebral nerve ablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oswestry Disability Index (ODI) score | 6 and 12 months post-procedure | |
| Change in Visual Analogue Score (VAS) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic low back pain of at least 6 months' duration that has not responded to at least 6 months of conservative treatment and who demonstrate Type 1 or Type 2 Modic changes on MRI consistent with vertebrogenic pain.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantor Spine Center | Recruiting | Fort Lauderdale | Florida | 33306 | United States |
Individual participant data will not be shared to protect patient confidentiality and because data sharing is not included in the informed consent or study protocol
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|
| 3 months post-procedure |
| Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36)) | 3, 6, and 12 months post-procedure |
| Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records | 3, 6 and 12 months post-procedure |
| Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.) | 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 | 6 weeks post-procedure |
| Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)) | 3, 6 and 12 months post-procedure |
| Assessment of global patient satisfaction through completion of a brief, non-validated, rating-scale questionnaire. | Non-validated, rating-scale questionnaire to assess perceived satisfaction with the treatment received, willingness to undergo the same treatment again for a comparable outcome, and willingness to recommend the treatment to an individual with the same medical condition | 3, 6 and 12 months post-procedure |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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