NCT04020211终止不适用
HF10 Therapy for the Treatment of Chronic, Focal, Neuropathic Pain Following Orthopedic Surgical Intervention of the Knee(s) - A Multicenter, Prospective Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Nevro Corp
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Responders and Improvement in Oxford Knee Score (OKS)
研究概览
简要总结
This is a multi-center study where patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery. The primary endpoint will be assessed at 3 months, but observational assessments will continue until study completion at 12 months following implant.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s).
- •Average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment.
- •Have a score of at least 4 out of 10 in Douleur Neuropathique 4 (DN4) questionnaire at the time of enrollment or eligibility verification.
- •Deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee.
- •Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
- •Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion #2, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
排除标准
- •Have radiculopathy or radicular leg pain resulting from failed back surgery.
- •Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia).
- •Have a current diagnosis of a progressive neurological disease such as multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, acute herniating disc, severe spinal stenosis and brachial plexus avulsion as determined by the Investigator.
- •Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the Investigator.
- •Have any prior experience with SCS.
- •Have objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator.
- •Be benefitting from an interventional procedure to treat their trunk or limb pain (Subjects should be enrolled at least 30 days from last benefit).
- •Have an existing drug pump and/or another active implantable device such as a pacemaker.
- •Be involved in an injury claim under current litigation.
- •Have an active or unsettled worker's compensation claim.
结局指标
主要结局
Responders and Improvement in Oxford Knee Score (OKS)
时间窗: 3 months
The OKS is a patient self-completion patient reported outcome containing 12 questions on activities of daily living with a recall period of 4 weeks. The OKS has been developed and validated specifically to assess function and pain after total knee replacement. The higher the score indicates improvement. The proportion of implanted subjects who are responders (achieved ≥ 50% pain relief) to HF10 therapy for treatment of their chronic, post-surgical knee pain or reporting at least a 4-point improvement in their Oxford Knee Score (OKS).
次要结局
- Change in Disability and Functioning(3, 6, and 12 months)
- Change in Functioning(3 and 12 months)
- Change in pain relief as measured by the Visual Analog Scale (VAS)(3 and 12 months)
- Change from baseline in pain experience: Short-Form McGill Pain Questionnaire (SF-MPQ-2) scores(3 and 12 months)
- Safety profile: Incidence of AEs over time(3, 6 and 12 months)
- Global Impression of Change(3 and 12 months)
- Change in Quality of Life as measured by the EuroQol five-dimensional questionnaire (EQ-5D-5L)(3 and 12 months)
- Change in Sleep as measured by the Pain and sleep Questionnaire (PSQ)(3 and 12 months)
- Medication(3 and 12 months)
- Safety profile: Neurological assessment over time by a physician and exam(3, 6 and 12 months)
研究者
研究点 (1)
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