OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Fusion Success
研究概览
简要总结
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material
详细描述
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:
- •Instability as defined by >3mm translation or >5 degrees angulation
- •Osteophyte formation of facet joints or vertebral endplates
- •Decreased disc height, on average by >2mm, but dependent upon the spinal level
- •Herniated nucleus pulposus
- •Facet joint degeneration/changes
排除标准
- •Subject is under 18 years of age at the time of consent
- •Subject has had prior lumbar spine fusion surgery at any level
- •Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy
- •Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
- •Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection
- •Subjects under workers compensation or active litigation
结局指标
主要结局
Fusion Success
时间窗: 12 months
Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success
次要结局
- Oswestry Lower Back Pain Questionnaire(12 months)
- SF36(12 months)
- Visual analog scale (VAS) of back and leg (left and right)(12 months)