NCT01873586已完成不适用
Efficacy and Safety of OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.
研究概览
简要总结
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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.
- •Require spinal fusion using TLIF, PLF or PLIF, with or without the use of an interbody spacer, at 1 to 3 levels between L3-S
- •Are willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 4 time points between 3 weeks and 12 months post-surgery (3 months ± 2 weeks, 6±1 months, 12±2 months and if required 24±3 months post-surgery), including one CT-scan at 12±2 months.
- •Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
- •Are willing and able to sign study specific informed consent.
排除标准
- •Are long term users of medications (i.e. steroids greater than 8 days) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. patients on inhaled steroids are allowed), or epidural steroid injections.
- •Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery.
- •Are being treated with radiotherapy.
- •Are having medical conditions, known to impact bone metabolism, such as Paget's disease, or has established osteoporosis (i.e. has had one or more fragility fractures).
- •Are pregnant, lactating or women wishing to become pregnant.
- •Are a prisoner.
- •Are smokers and/or nicotine/tobacco users
- •Are currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
- •Had prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures.
- •Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).
研究组 & 干预措施
OsteoStrux Collagen Ceramic Scaffold
Experimental
OsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side)
干预措施: Posterolateral Fusion (Procedure)
Local autograft
Active Comparator
Local autograft (posterolateral gutter at the contralateral side)
干预措施: Posterolateral Fusion (Procedure)
结局指标
主要结局
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.
时间窗: up to 24 months
Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
次要结局
- Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT(12 months)
- Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months(upto 24 months)
- EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points(upto 24 months)
- Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.(upto 24 months)
- Interbody Fusion as Determined by CT Post-surgery at Available Time-points(12 months)
- Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan(12 months)
- Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.(upto 24 months)
- Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.(upto 24 months)
- Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.(upto 24 months)
研究者
研究点 (2)
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