A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Back and Leg Pain Measured by Visual Analogue Scales (VAS)
研究概览
简要总结
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is 18 years of age or older.
- •Patient agrees to participate in the study and is able to sign the informed consent/data release form.
- •Patient is undergoing surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.
排除标准
- •Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).
结局指标
主要结局
Back and Leg Pain Measured by Visual Analogue Scales (VAS)
时间窗: 24 months
Oswestry Disability Index (ODI)
时间窗: 24 months
European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire
时间窗: 24 months
Neurological deficits assessed by neurological status
时间窗: 24 months
Neurological status is based on seven components of measurements: Motor function; Sensory function; Deep Tendon reflexes; Sympathetic Exam; Claudication; Urinary bladder retention/Bowel retention; and Sexual Dysfunction.
Rate of adverse events
时间窗: 24 months
次要结局
未报告次要终点