NCT02070484终止不适用
Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- OhioHealth
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 75 years
- •Symptomatic, single-level degenerative lumbar disc disease, spondylosis or spondylolisthesis
- •Failed conservative treatments
- •Low risk for non-union
- •Must be candidates for single-level, posteriolateral lumbar spine fusion
- •Must be able and willing to give Informed Consent
- •English-speaking
排除标准
- •Smoker (any smoking ≤3 months prior to consent); (Patel et al. 2013)
- •Patients with poorly controlled diabetes mellitus (HgbA1c > 7%)
- •Documented osteoporosis
- •Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine level, to the level being operated on
- •Back pain due to infection, tumour, or metabolic bone disease
- •Terminal disease, such as HIV infection, neoplasm
- •Autoimmune disease, such as rheumatoid arthritis
- •Morbid obesity (body mass index (BMI) of 35 kg/m2)
- •Major psychiatric illness in the last year
- •History of alcohol or drug abuse in the last year
- •Pregnant women
研究组 & 干预措施
NuCel
Experimental
Stemcell allograft
干预措施: NuCel (Biological)
Demineralized Bone Matrix (DBM)
Active Comparator
Demineralized Bone Matrix (DBM) bone graft substitute
干预措施: Demineralized Bone Matrix (Biological)
结局指标
主要结局
Oswestry Disability Index
时间窗: 6 months
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
次要结局
- Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion(6 and 12 months)
研究者
Joseph A. Shehadi, MD
Principal Investigator
OhioHealth
研究点 (4)
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