OP-1 Putty for Posterolateral Fusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 24
- 主要终点
- Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
研究概览
简要总结
The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.
详细描述
A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
- •The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
- •The subject requires one level lumbar fusion (L-3 to S-1).
- •The subject has a preoperative Oswestry Disability Index of 30-100.
排除标准
- •The subject has active spinal and/or systemic infection.
- •The subject is morbidly obese.
- •The subject has a known sensitivity to any component of the OP-1 Putty.
- •The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
- •The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.
结局指标
主要结局
Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
时间窗: 3, 6, 12, 24 months
次要结局
- The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use(3, 6, 12, 24 months)