NCT01850537Unknown不适用
Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
NLT Spine1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Fusion rate
研究概览
简要总结
This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).
详细描述
Primary endpoints:
- Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded.
- Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •main Inclusion Criteria
- •Male and female between 18-65 years of age (skeletally mature).
- •Subjects suffering from degenerative disc disease (DDD) accompanied by back pain with leg pain at a single level between L2 and S1 confirmed by history and radiographic studies and that are scheduled for a fusion operation. DDD is determined to be present if one or more of the following are noted:
- •instability (defined as angulation ≥ 5° and/or translation ≥ 4mm on flexion/extension radiographs);
- •osteophyte formation;
- •decreased disc height;
- •ligamentous thickening;
- •disc degeneration/herniation; or
- •facet joint degeneration.
- •A pre-op Oswestry Low Back Pain Disability Questionnaire (ODI) score of 35 % or more;
- •Be non-responsive to non-operative treatment for at least 6 months;
排除标准
- •The Antero-Posterior (AP) diameter (at midline) of the involved level is <31mm.
- •Any previous spinal surgery at the involved level;
- •Spondylolisthesis > grade I;
- •Ankylosed segment at the affected level;
- •History or radiographic evidence of osteoporotic fractures in the spine;
- •Paraparesis;
- •Progressive neurologic conditions;
结局指标
主要结局
Fusion rate
时间窗: 24 months follow up
Primary radiographic effectiveness outcome parameter: evaluations of fusion. Fusion will be evaluated at 6 months, 12 months and 24 months post-op using plain radiographs (AP, lateral and flexion/extension films) and at 24 months using CT scan as well
次要结局
未报告次要终点
研究者
研究点 (1)
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