Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - a Prospective, Multicenter, Randomized Controlled Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- Visual Analogue Scale (VAS) lower back pain
研究概览
简要总结
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.
The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.
详细描述
Dynamic stabilization systems for the lumbar spine are no novelty. The SpineShape System IV builds on the experience of previous systems and attempts to provide additional benefits primarily through three different and relatively elastic rod stiffnesses. 126 subjects with degenerative symptoms in 1 to 2 segments of the lumbar spine L1 to S1 will be recruited. The participants will be randomized in a 1:1:1 ratio to undergo implantation of either the elastic (experimental product group 1), medium (experimental product group 2) or stiff rod (comparison product group).
The aim of the study is to show that the treatment of degenerative lumbar spine with elastic or medium rod variants is not inferior to treatment with hard rods in terms of clinical and safety-related results. This is checked by completing a questionnaire before the surgical procedure and 3 months, 12 months, 24 months and 60 months after the surgical procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
- •signed informed consent of participant
- •confirmation of the participant that the attendance of follow-up visits are intended
- •Body-Mass-Index < 32
- •Pedicle screw axis distance < 30mm
- •one or more of the following indications:
- •(dynamic) stenosis in the spinal canal
- •neuroforaminal stenosis
- •facet joint syndrome / spondylarthrosis
- •discopathy (recurrent disc hernia)
- •degenerative spondylolisthesis (Meyerding <1)
- •instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)
排除标准
- •missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible
- •damaged structural tissue, e.g. due to a bone fracture
- •application to the thoracic or cervical spine
- •pronounced idiopathic scoliosis
- •spondylolisthesis > Meyerding grad 1
- •isthmic spondolylysis
- •bone tumor
- •osteochondrosis modic type I, II or III
- •osteoporosis, which could impair screw anchoring
- •history with third party implants
- •patients with an active local or systemic infection
- •known allergy to titatnium alloys
- •skeleton in growth (epiphyseal joints not closed)
- •severe muscular neuronal or vascular disease
- •immunosuppresive therapy
- •long-term therapy with cortisone
- •heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics
- •chronic pain patients
- •incapable of judgment or emergency situation
- •implantation during pregnancy
结局指标
主要结局
Visual Analogue Scale (VAS) lower back pain
时间窗: 24 months post-implantation
self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
次要结局
- segmental mobility index level(3, 12, 24, 60 months post-implantation)
- medication consumption(3, 12, 24, 60 months post-implantation)
- Visual Analogue Scale (VAS) leg pain(3, 12, 24, 60 months post-implantation)
- walking duration(3, 12, 24, 60 months post-implantation)
- adverse events(after 3, 12, 24, 60 months post-implantation)
- ability to work/ activity (for retirees)(3, 12, 24, 60 months post-implantation)