NCT00679107已完成不适用
A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
研究概览
简要总结
This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.
详细描述
It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.
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 81 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
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
时间窗: 6 weeks; 3, 6, 9, 12, and 24 months
次要结局
- Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).(6 weeks; 3, 6, 9, 12, and 24 months)
研究者
研究点 (5)
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