A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 554
- 试验地点
- 21
- 主要终点
- No radiographic evidence of recurrent disc herniation
研究概览
简要总结
A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.
详细描述
The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), and a posterior or posterolateral herniation at one level between L1 and S1 with radiographic confirmation of neural compression using MRI who are found to have an annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment including a post-approval amendment with follow-up visits at 7 & 10 years for eligible subjects.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 75 years old and skeletally mature (male or female).
- •Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI).
- •At least six (6) weeks of failed, conservative treatment prior to surgery
- •Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline.
- •Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline.
- •Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
排除标准
- •Spondylolisthesis Grade II or higher (25% slip or greater).
- •Prior surgery at the index lumbar vertebral level.
- •Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
- •Any metabolic bone disease.
- •Subject has insulin-dependent diabetes mellitus.
- •Subject has been diagnosed with active hepatitis, acquired immunodeficiency syndrome (AIDS), or Human immunodeficiency virus (HIV).
- •Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
- •Subject has a known allergy to titanium, polyethylene or polyester materials.
- •Any subject that cannot have a baseline MRI taken.
- •Subject is pregnant or interested in becoming pregnant in the next three (3) years.
- •Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
- •Subject is currently involved in another investigational study.
- •Any contraindication for MRI or Computed tomography CT scan (e.g. claustrophobia, contrast allergy).
研究组 & 干预措施
Barricaid Device
Intervention: Barricaid Device
干预措施: Barricaid (Device)
Standard of Care
Standard (Limited) Discectomy Only
干预措施: Standard of Care (Device)
结局指标
主要结局
No radiographic evidence of recurrent disc herniation
时间窗: 24 months
To be considered a success, a patient will have no evidence of recurrent disc herniation at the index level at any time up to and including the 24-month follow-up. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review (unless surgically confirmed that the suspected herniation is not a herniation, e.g. scar tissue or residual nucleus material).
Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures
时间窗: 24 months
To be considered a success, a patient will have achieved success in each of the following outcomes: * 15 point (out of 100 point scale) improvement in Oswestry compared to pre-op * 20 point (on a 100 point scale) improvement in VAS Leg (based on the primary leg complaint; if both legs have a minimum of 40/100 pre-operatively, the average leg score will be used) * Maintenance of average disc height (75% or greater of preoperative disc height) compared to pre-op * No deterioration of neurological status at the index level measured by motor function * Device integrity and lack of implant migration (radiographic, implanted patients only) * No radiographically confirmed spontaneous fusion * No radiographically or surgically confirmed reherniation at the index level (on either side) * No secondary surgical interventions at the index level
次要结局
- Disc Height Maintenance(24 months)
- Visual Analog Scale (VAS) Back Pain Improvement(24 months)
- Visual Analog Scale (VAS) LEG Pain Improvement(24 months)
- Oswestry Disability Index (ODI) Improvement(24 months)
- Reoperation(24 months)