A Randomized, Single Blind, Controlled Trial of Clinical Outcomes of Dehydrated Human Amnion/Chorion Membrane (dHACM) in Lumbar Decompression and Microdiscectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
详细描述
The objective of this prospective study is to evaluate the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients randomized to one of two groups: 1) without dHACM (control) or 2) dHACM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Are 18 (eighteen) years of age or older at the time of surgery.
- •Patients with single- or multi-level spinal stenosis undergoing open lumbar laminectomy, or patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy
- •Are willing and able to return for the scheduled follow-up visits, follow post operative instructions and undergo the required radiographic exams for up to 5 time points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2 weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery), including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled.
- •Are willing and able to sign study specific informed consent.
排除标准
- •Non-English speaking patients
- •Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
- •Allergic to aminoglycoside antibiotics
- •Is a prisoner
- •Is involved in worker's compensation or other litigation relative to the spine injury
- •Has a history of drug or alcohol abuse within the last 12 months
- •Is currently participating in another drug or device clinical trial
- •Previous spinal surgery
- •History of deformity, mechanical instability, or spinal fusion requirement
- •History of hard- or soft-tissue spinal infection
- •Has signs or symptoms of any disease, such as autoimmune disease, which could result in allograft failure, or has experienced allograft failure in the past
- •Patients unable to undergo a MRI
研究组 & 干预措施
dHACM
Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
干预措施: Lumbar Decompression Surgery (Procedure)
Surgery without dHACM
Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM
干预措施: Lumbar Decompression Surgery (Procedure)
Surgery without dHACM
Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM
干预措施: Microdiscectomy Surgery (Procedure)
dHACM
Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
干预措施: Dehydrated Human Amnion/Chorion Membrane (dHACM) (Other)
dHACM
Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
干预措施: Microdiscectomy Surgery (Procedure)
结局指标
主要结局
Oswestry Disability Index
时间窗: 2 years
Patient Functional Outcomes Questionnaire
次要结局
- Quality of Life (SF-36)(2 years)
- Re-operation (Number of patients having re-operation during study)(2 years)
- Quality of Life (VAS Pain)(2 years)
- Scar formation in revision cases(2 years)
- Quality of Life(2 years)