A Multi-center Study to Evaluate the Safety and Efficacy of DePuy AcroMed Titanium Surgical Mesh and MOSS-Miami Spinal Fixation System Pedicle Screws for Intradiscal Fusion in the Lumbar Spine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- DePuy Spine
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Radiographic Fusion
研究概览
简要总结
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
详细描述
This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2 - S1).
Study Success is as a compound endpoint requiring:
- Radiographic Fusion,
- Improvement in Pain/Function,
- Maintenance/Improvement in Neurologic Status, and
- Freedom from Secondary Surgical Intervention.
- The rate of Adverse Events must be no worse than in the control group as well.
Secondary Endpoints Include:
- Adverse Events
- SF-36 Health Related Quality of Life
- Disc Space Height
- Work Status
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
- •Radiographic evidence of significant disc degeneration at one or two of the adjacent lumbar levels L2-S1.
排除标准
- •Abnormality at more than two levels,
- •Prior fusion surgery of the lumbar spine; prior discectomies or IDET allowed,
- •Infection in the disc or spine, past or present,
- •Active infection at time of surgery,
- •Tumor in the spine,
- •Significant osteoporosis or metabolic bone disease,
- •Greater than Grade I spondylolisthesis or significant bony defect in the lumbar spine,
- •Pregnant or lactating, or wishes to become pregnant within duration of study,
研究组 & 干预措施
TSM Cage
Lumbar I/F with cage and pedicle screws
干预措施: Lumbar I/F with cage and pedicle screws (Device)
结局指标
主要结局
Radiographic Fusion
Oswestry Disability Index
Motor Function
Adverse Events
Secondary Surgical Interventions
次要结局
- Graft site pain
- Back pain
- Disc space height
- SF-36
- Leg pain