Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Pain as Measured by Visual Analog Scale (VAS).
研究概览
简要总结
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.
详细描述
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
- •Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
- •Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
- •Central canal cross sectional area clearly reduced per MRI/CT report
- •If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
- •Able to walk at least 10 feet unaided before being limited by pain
- •Available to complete 26 weeks of follow up
- •A signed Consent Form is obtained from the patient
- •Adults 18 years of age or older
排除标准
- •Prior surgery at the intended treatment level
- •Compound fracture with intraspinal retropulsion contributing to spinal stenosis
- •Disabling back or leg pain from causes other than lumbar spinal stenosis
- •Disc protrusion or osteophyte formation severe enough to confound study outcome
- •Facet hypertrophy severe enough to confound study outcome
- •Bleeding disorders and/or current use of anti-coagulants
- •Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
- •Epidural steroids with 3 weeks prior to procedure
- •Inability of patient to lie prone for any reason with anesthesia support
- •Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
- •Dementia and/or inability to give informed consent
- •Pregnant and/or breastfeeding
- •On workman's Compensation or considering litigation associated with back pain
结局指标
主要结局
Pain as Measured by Visual Analog Scale (VAS).
时间窗: Baseline and six months
A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.
次要结局
- Improvement in Functional Mobility(baseline and month 6)
- Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).(Baseline and month 6)
- Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).(Baseline and month 6)