NCT02018445已完成不适用
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), 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 Accell Evo3 Demineralized Bone Matrix 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
- Na
- 干预模型
- Single Group
- 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 Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Fusion (PLF) or Posterior Lumbar Interbody Fusion (PLIF), with or without the use of an interbody spacer, at 1 to 3 levels between L3-S
- •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 2 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.
- •Unresponsive to conservative care over a period of at least 6 months or has signs and/or symptoms that mandate urgent surgical intervention.
- •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. subjects 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, osteoporosis, severe degenerative bone disease.
- •Are smokers and/or nicotine/tobacco users.
- •Have a Body Mass Index (BMI) ≥ 40
- •Are pregnant, lactating or women wishing to become pregnant.
- •Are a prisoner.
- •Are currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
- •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 any other bone graft or bone graft substitute in addition to or in place of Accell Evo3 and/or local autograft.
- •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).
- •Have a known sensitivity Polymyxin Sulfate B, Bacitracin, Gentamycin and/or Iodine.
- •Severe vascular or neurological disease.
- •Uncontrolled diabetes.
- •Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol.
- •Renal impairment.
- •Active or latent infection in or around the surgical site.
- •Accell Evo3 is contraindicated when there is significant vascular impairment proximal to the implantation site and when there are metabolic or systemic bone disorders that affect bone or wound healing, or when stabilization of the defect is not possible.
- •The use of Accell Evo3 is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible and in infected or contaminated wounds.
结局指标
主要结局
Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.
时间窗: 12 months
There were 29 patients and 43 total spinal levels (unit) treated at baseline. Time to arthodesis was measured as the mean time to achieve fusion. At each time point fusion was evaluated, the first time point fusion was achieved was considered fusion.
次要结局
- Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan(12 months)
- Medical Outcomes: Oswestry Disability Index (ODI)(12 months)
- Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS)(12 months)
- Medical Outcomes: Back Pain Visual Analog Scale (VAS)(12 months)
- Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS).(12 months)
- Medical Outcomes: Maintenance of Lower Extremity Neurological Function(12 months)
- Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions(24 months)
研究者
研究点 (2)
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