NCT01406405已完成不适用
Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Pain Intensity Scores
研究概览
简要总结
Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.
详细描述
Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Skeletally mature adults between 18 and 70 years old
- •Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels
- •Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
- •Willing and able to comply with the requirements of the protocol including followup requirements
- •Willing and able to sign a study specific informed consent.
排除标准
- •More than 3 intervertebral levels to be fused
- •Posterior fixation used at more than 1 level for 1-level intervertebral fusion
- •Posterior fixation used at more than 2 levels for 2-level intervertebral fusion
- •Posterior fixation used at more than 3 levels for 3-level intervertebral fusion
- •Any additional approaches, e.g. anterior, XLIF
- •Active local or systemic infection
- •Prior interbody fusion surgery at the index level
- •Prior fusion at the adjacent levels
- •Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
- •Cervical Fusion Patient Group
- •Inclusion Criteria:
- •Skeletally mature adults between 18 and 70 years old
- •Patients with neck and/or arm pain due to degenerative disc disease, scheduled for ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3 adjacent levels
- •Completed at least 6 weeks of conservative therapy or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
- •Willing and able to comply with the requirements of the protocol including followup requirements
- •Willing and able to sign a study specific informed consent
- •Exclusion Criteria:
- •More than 3 vertebral levels to be fused
- •Any additional approaches, e.g. posterior cervical fusion
- •Active local or systemic infection
- •Prior interbody fusion surgery at the index level
- •Prior fusion at the adjacent level
- •Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
结局指标
主要结局
Pain Intensity Scores
时间窗: 24 (+/- 2) months
Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment.
次要结局
- Clinical and Radiographic Outcomes(3 (+/-2) weeks and 24 (+/- 2) months)
研究者
研究点 (1)
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