A Prospective and Randomized Controlled Trial to Evaluate the Safety and Effectiveness of Total Facet Arthroplasty in the Treatment of Degenerative Spinal Stenosis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 450
- 主要终点
- The primary safety and efficacy evaluation endpoints to determine individual patient success are the Zurich Claudication Questionnaire (ZCQ), neurologic status, solid fusion for the control (spinal fusion) group.
研究概览
简要总结
The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal. TFAS® offers the surgeon new options for treating spinal stenosis patients, enabling a more comprehensive decompression via complete removal of the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion. The clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures.
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
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5
- •Skeletally mature male or female between the ages of 50 and 85 years of age inclusive
- •No greater than Grade I degenerative spondylolisthesis at the index level
- •Persistent leg symptoms,including pain, numbness, burning or tingling for a minimum duration of six months
- •Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression
- •Failed to respond to non-operative treatment modalities for a minimum duration of six months
排除标准
- •Male or female less than 50 or greater than 85 years old Grade 2 or higher spondylolisthesis or any retrolisthesis at the index level
- •More than 3 vertebral levels of degenerative spinal stenosis requiring decompression
- •More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation
- •Not available for long term follow-up and interval visits
- •Prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine
- •Two or more previous surgeries to the lumbar spine at the same level to be implanted
- •Is being treated with other devices for the same disorder (e.g. pain control devices)
- •Active systemic infection or infection at the operating site
- •Osteoporosis
- •Known sensitivity to device materials
- •Has an immunosuppressive disorder
- •Has a medical condition that may interfere with clinical evaluations
- •Is obese defined by a patient body mass index greater than 40
- •Has significant scoliosis (Cobb >25°)
- •Is pregnant or planning to become pregnant within the proposed three year investigation
结局指标
主要结局
The primary safety and efficacy evaluation endpoints to determine individual patient success are the Zurich Claudication Questionnaire (ZCQ), neurologic status, solid fusion for the control (spinal fusion) group.
次要结局
- Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.