NCT07392333招募中不适用
A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
OptaBate BVN cohort
干预措施: Basivertebral nerve ablation (Device)
结局指标
主要结局
Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score
时间窗: 3 months post-procedure
Incidence and severity of adverse events related to the procedure and/or device.
时间窗: 12 months post-procedure
次要结局
- Change in ODI(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 ODI improvement ≥10 points and VAS reduction ≥2 cm(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(3, 6 and 12 months post-procedure)
研究者
研究点 (1)
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