An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 290
- 试验地点
- 68
- 主要终点
- Secondary surgical intervention
研究概览
简要总结
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(abbreviated):
- •Skeletally mature adults between 22 and 80 years old (inclusive);
- •Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;
- •Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;
- •Involved disc(s) between L2 and S1;
排除标准
- •(abbreviated):
- •Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;
- •Active malignancy;
- •Nondiscogenic source of symptoms (e.g. tumor, etc.);
- •Multiple level symptomatic degenerative disc disease where more than one level requires fusion;
- •Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;
- •More than one level to be fused
研究组 & 干预措施
P-15L Bone Graft
The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
干预措施: P-15L Bone Graft (Device)
Local autologous bone
The active control group will be treated with local autologous bone in an instrumented TLIF
干预措施: Local autologous bone in a TLIF with Instrumentation (Other)
结局指标
主要结局
Secondary surgical intervention
时间窗: 72 Months
No index level secondary surgical intervention
Fusion
时间窗: 72 Months
Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
Oswestry Disability Index (ODI)
时间窗: 72 Months
At least 15-point improvement in Oswestry Disability Index (ODI)
Neurological deficit
时间窗: 72 Months
No new or worsening, persistent neurological deficit
No serious device-related adverse event
时间窗: 72 Months
No serious device-related adverse event
次要结局
- Time to Fusion(24 months)
- VAS pain scores(72 months)
- Physical Function and Mental Health Composite Scores(72 months)