Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) <=4
研究概览
简要总结
This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
- •Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of >20%.
- •Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically > 2.5mm)confirmed by pre op MRI and/or CT.
- •Central canal cross sectional area clearly reduced per MRI/CT report.
- •If present, anterior listhesis ≤ 5.0mm (preferred) and stable.
- •Able to walk at least 10 feet unaided before being limited by pain.
- •Available to complete 26 weeks of follow-up.
- •A signed Informed consent Form is obtained from the subject.
- •Adults at least 18 years of age.
排除标准
- •Prior surgery at intended treatment level.
- •History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
- •Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
- •Disk 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 (NSAID) within five days of treatment.
- •Epidural steroid administration within prior 3 weeks(of procedure or sham)
- •Inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
- •Metabolic wound healing pathologies deemed by Investigator to compromise study outcome.
- •Dementia and/or inability to give informed consent.
- •Pregnancy and/or breastfeeding.
- •On Workman's Compensation or considering litigation associated with back pain.
研究组 & 干预措施
Decompression with mild® Device Kit
Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).
干预措施: Percutaneous Lumbar Decompression (Device)
Sham lumbar decompression
Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.
干预措施: Sham lumbar decompression (Device)
结局指标
主要结局
Visual Analog Scale (VAS) <=4
时间窗: Week 6 to 12 & Year One After Sham to mild x-over
VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below.
Visual Analog Scale (VAS) Mean Improvement
时间窗: Baseline and Year 1
VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.
Visual Analog Scale (VAS) <=4
时间窗: Week 6 to 12 prior to cross-over
Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.
次要结局
未报告次要终点
研究者
Eric J. Grigsby, MD
Founder / Medical Director
Napa Pain Institute