NCT02704689终止不适用
A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine
Stryker Spine2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年6月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
研究概览
简要总结
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.
详细描述
Study evaluations will be evaluated pre-operatively and at 6-weeks, 3-months, 6-months, 12-months and 24-months post-operatively to assess clinical outcomes, patient reported outcomes and radiographic status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is skeletally mature and between 18 and 70 years of age.
- •DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S
- •No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
- •Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
- •Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
- •Subject agrees to comply with visit schedule and completing study questionnaires.
排除标准
- •Significant instability of the spine.
- •Requires TLIF at more than 2 levels between L2 and S
- •Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
- •Younger than 18 years of age, or older than 70 years of age.
- •BMI of 40 or greater.
- •History of metabolic bone disease
- •Osteoporosis
- •Diabetes mellitus requiring daily insulin management.
- •Subject has any of the following:
- •Progressive neuromuscular disease; OR
- •Autoimmune disease; OR
- •Active malignancy within the last 15 years; OR
- •Active hepatitis; OR
- •AIDS, ARC, or is HIV positive; OR
- •Syringomyelia at any spinal level; OR
- •Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.
- •Allergy to implant materials (titanium, titanium alloy).
- •Active systemic infection or infection localized to the site of implantation.
- •Primary or metastatic tumors involving the spine.
- •Open wounds or inadequate issue tissue coverage over the operative site.
- •History of significant mental illness or mental incapacity.
- •Pregnancy or intent to become pregnant.
- •Participating in another investigational study for a similar purpose.
- •Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements.
- •Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years.
- •Workers compensation.
研究组 & 干预措施
AccuLIF
Experimental
干预措施: AccuLIF expandable TLIF cage (Device)
结局指标
主要结局
Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
时间窗: 24 months
Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.
Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.
时间窗: 24 months
Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.
次要结局
- Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.(24 months)
- Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.(Peri-op)
- Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.(24 months)
- Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.(24 months)
- Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.(24 months)
- Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.(24 months)
- Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.(Operative Visit)
- Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.(Operative Visit)
- Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings(24 months)
- Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.(24 months)
- Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.(24 months)
- Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).(24 months)
研究者
研究点 (2)
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