Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 主要终点
- Number of Subjects With Improvement of at Least 15 Points in ODI
研究概览
简要总结
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
详细描述
The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).
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
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Subjects With Improvement of at Least 15 Points in ODI
时间窗: 5 years
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation
时间窗: 5 years
Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).
Number of Subjects With no Persistent New or Increasing Sensory Deficit
时间窗: 5 years
No persistent new or increasing sensory deficit
Number of Subjects With no Major Device Related Complications
时间窗: 5 years
Assessment of major device-related complications at 5 years
Number of Subjects With no Epidural Injection(s)
时间窗: 5 years
Assessment of lumbar epidural injections
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit
时间窗: 5 years
No persistent new or increasing sensory or motor deficit
Number of Subjects With no Reoperations or Epidural (Up to Day 1825)
时间窗: 5 years
No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.
Number of Subjects With no Persistent New or Increasing Motor Deficit
时间窗: 5 years
No persistent new or increasing motor deficit
次要结局
- Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points(5 years)
- Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points(5 years)
- Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component(5 years)
- Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component(5 years)
- Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm(5 years)
- Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm(5 years)
- Mean Oswestry Disability Index (ODI) Score(5 years)
- Mean Visual Analog Scale Back Pain Score(5 years)
- Mean Visual Analog Scale Leg (Worse) Pain Score(5 years)
- Mean Visual Analog Scale (VAS) Leg (Right) Pain Score(5 years)
- Mean Visual Analog Scale (VAS) Leg (Left) Pain Score(5 years)
- Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score(5 years)
- Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm(5 years)
- Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm(5 years)
- Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score(5 years)
- Mean Short Form-12 Physical Component Score(5 years)
- Mean Short Form-12 Mental Component Score(5 years)
- Patient Survey: Satisfaction(5 years)
- Patient Survey: Recommendation of Treatment(5 years)
- Pain Management: Class II Narcotics Usage by Device Group(5 years)
- Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group(5 years)