A Prospective Randomized Clinical Investigation of the FLEXUS(TM) Interspinous Spacer: A Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated
研究概览
简要总结
The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar spinal stenosis as defined by leg, buttock or groin pain, with or without back pain, that relieves during flexion, with radiographic confirmation of spinal stenosis by CT or MRI scans at one or two contiguous levels between L1 and S
- •If back pain is also present, it must be partially relieved during flexion
- •Narrowing of the spinal canal, nerve root canal or intervertebral foramen at one or two levels
- •Able to sit for 50 minutes without pain
- •Able to walk 50 feet or more
- •Age 50 years or over
- •Has completed at least 6 months of conservative treatment
- •Has a Zurich Claudication Questionnaire (ZCQ) score of ≥ 1.5 for Physical Function (PF) and ≥ 1.5 for Symptom Severity (SS)
- •Other as specified in the approved protocol
排除标准
- •Cannot sit for 50 minutes without pain
- •Cannot walk for more than 50 feet
- •Unremitting pain in any spinal position
- •Axial back pain only without leg, buttock, or groin pain
- •Fixed motor deficit
- •Cauda equine syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retension or incontinence) dysfunction
- •Severe symptomatic lumbar spinal stenosis at more than two levels
- •Significant instability of the lumbar spine
- •Has had any surgery of the lumbar spine
- •Morbid obesity defined as a body mass index >40 or a weight more than 100 lbs over ideal body weight
- •Active systemic disease such as AIDS, HIV, Hepatitis, etc.
- •Active systemic or local infection
- •Angina, active rheumatoid arthritis, advanced diabetes or any other systemic disease that would affect the subject's welfare or outcome of the study
- •Osteoporosis, defined as DEXA bone density measured T-score < -2.5
- •Spinal metastasis to the vertebrae
- •Known allergy to device materials titanium, tantalum, or polyetheretherketone (PEEK) polymer
- •Other as specified in approved protocol
研究组 & 干预措施
FLEXUS™ Interspinous Spacer
干预措施: FLEXUS(TM) Interspinous Spacer (Device)
XSTOP® Interspinous Spacer
干预措施: XSTOP® Interspinous Spacer (Device)
结局指标
主要结局
Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated
时间窗: 24 months
Measures the number of participants who did not have another surgery for treatment of lumbar spinal stenosis at the same spinal level that was originally treated. Data, including adverse events, were monitored, evaluated and assessed for evidence of additional surgical treatment at the spinal level that was originally treated.
Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score
时间窗: 24 months
Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows: * Change of \>0.5 points in Physical Function on a scale of 1-4 points (lower values are considered a better outcome) * Change of \>0.5 points in Symptom Severity on a scale of 1-5 points (lower values are considered a better outcome) * Satisfaction of \<2.5 points on a scale of 1-4 points (lower values are considered a better outcome) The Zurich Claudication Questionnaire is a three part form that quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
Number of Participants With a Successful Neurologic Status
时间窗: 24 months
Neurological status is based on four types of measurement parameters: motor, sensory, reflexes, and special assessments. Each parameter will be coded as follows: Motor 0 Total Paralysis 1. Palpable or Visible Contraction 2. Active Movement, Gravity Eliminated 3. Active Movement, Against Gravity 4. Active Movement, Against Some Resistance 5. Active Movement, Against Full Resistance Sensory 0 Absent 1. Impaired 2. Normal Reflexes 0 Absent or Trace 1. Hyper-reflexic 2. Normal or hypo-reflexic Straight Leg Raise 0 0°-70° (abnormal) 1 \>70°-90° (normal) If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. The overall neurological status will be considered a success if and only if all the four parameters are stable or improved.
Number of Participants With an Absence of Implant-related Complications
时间窗: 24 months
Absence of implant-related complications, including device dislodgement, defined as: * Failure of implant material (e.g. fracture); * Implant migration outside of the interspinous space (posteriorly beyond the posterior margin of the spinous processes, anteriorly within the spinal canal, or laterally more than half of the implant width); or * Other complications that can be specifically associated with the implanted device.
次要结局
- Mean Visual Analog Scale (VAS) - Back Pain at 24 Months(24 months)
- Change of Quality of Life(24 months)
- Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months(24 months)
- Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months(24 months)
- Mean Oswestry Disability Index (ODI) at 24 Months(24 months)