Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
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 posterolateral spine fusion with a retrospective comparison to a historical patient cohort.
详细描述
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort. The historical patient cohort has not been previously published and therefore, no reference to this group can be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 years of age or older at the time of surgery
- •Require spinal fusion using posterior Transforaminal Lumbar Interbody Fusion (TLIF), Posterolateral Fusion (PLF) or Posterior Lumber Interbody Fusion (PLIF) in 1 to 3 levels between L3-S1
- •Follow-up radiographic imaging post surgery
排除标准
- •Long term users of medications known to inhibit fusion,bone metabolism or epidural steroid injections
- •Immunosuppressive agents, Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs, Growth Factors or Insulin
- •Treated with radiotherapy since their surgery
- •Medical conditions known to impact bone metabolism, such as Paget's disease, osteoporosis
- •Pregnant or lactating women or women wishing to become pregnant
- •Participating in an investigational drug or another device study
研究组 & 干预措施
Demineralized Bone Matrix
a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
干预措施: Demineralized Bone Matrix (Device)
rh-BMP2
A retrospective cohort of patients who were age- and sex- matched to the prospective cohort who underwent posterolateral lumbar fusion with use of rh-BMP2
干预措施: rh-BMP2 (Device)
结局指标
主要结局
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
时间窗: 12 months
Posterolateral fusion by radiographic assessment 12 months post surgery
次要结局
未报告次要终点