DEGENERATIVE DISC DISEASE TREATED BY DECOMPRESSION AND ARTHRODESIS USING A PEEK-TITANIUM POLYAXIAL INTERSPINOUS POSTERIOR FUSION DEVICE: ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Spineart SA
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- ODI
研究概览
简要总结
This study is designed as a post-marketing observational, controlled, prospective, non-inferiority study where the efficacy and safety of the Degenerative Disc Disease treatment by arthrodesis using PEEK(PolyEtherEtherKetone)-Titanium polyaxial interspinous posterior fusion device ROMEO®2 PAD will be compared to the gold standard treatment by instrumented circumferential arthrodesis.
The primary study aim is to evaluate functional improvement at 1 and 2 years after surgery. The fusion at 1 year and 2 years post-surgery, the short and long- term clinical and neurological success and patient related health status satisfaction will also be evaluated.
详细描述
Lumbar spine fusion is the gold standard technique for the treatment of low-back pain due to various spinal pathologies mostly related to degenerative conditions. Pedicle-screws constructs are widely used to achieve a strong fixation but may be associated with potential complications.
ROMEO® 2 PAD is composed of two polyaxial titanium teethed plates to adapt to anatomical variations, one step locking mechanism and a radiolucent polymer cylinder.
The ROMEO®2 PAD is a posterior non pedicle supplemental fixation device intended for use in combination with an inter-somatic device, to achieve fusion at single or multilevel in the lumbar spine (L1-S1 inclusive). A range of six heights (from 8 to 18mm) are designed to fit anatomical variations. It is intended for plate fixation to the spinous process for the purpose of achieving spinal fixation.
The main objective of the study is the evaluation of functional improvement as measured by changes in Oswestry Disability Index (ODI) at 12 and 24 months after surgery, respectively.
The secondary objectives are:
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical treatment of stenosis and Grade I degenerative spondylolisthesis, secondary to lumbar degenerative disc disease at one level between L1 and L5 in skeletally mature patients
排除标准
- •Vertebral traumatic lesions including dislocation;
- •Insufficient vertebral body bone quality;
- •Severe osteoporosis;
- •Bone tumor in the region of the implant;
- •Spondylolysis;
- •Lytic spondylolisthesis;
- •Degenerative spondylolisthesis Grade II or more;
- •Mental illness or inadequate patient activity;
- •Infection;
- •Vascular disorders or illness;
- •Pregnancy
结局指标
主要结局
ODI
时间窗: 24 months
Absolute change in ODI at 12 and 24 months post-operative compared to baseline (pre-operative status)
次要结局
未报告次要终点