NCT02551302Unknown不适用
"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Changes in the subscores of physical pain and physical function in the ODI Questionaire
研究概览
简要总结
Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™)
详细描述
Posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (CD HORIZON BalanC™ Manufacturer: Medtronic)
Control:
Posterior spondylodesis and monosegmental intervertebral cage
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Legal capacity
- •Age ≥ 30 years
- •Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III [20][21][22] or spondylolisthesis Meyerding grades I-III.
- •Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability
排除标准
- •Motor deficit
- •Cauda equina syndrome
- •Previous surgical intervention of the lumbar spine
- •Relevant peripheral neuropathy
- •Acute denervation subsequent to a radiculopathy
- •Scoliosis with Cobb angle greater than 25°
- •Spondylolisthesis > Meyerding grade III
- •Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)
- •No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)
- •Radiologic signs of degeneration in the adjacent segment of the intended fusion with >Fujiwara grade II [15] or >Pfirrmann grade IV [14]
- •Signs of instability in any lumbar spine segment other than that undergoing fusion
- •General contraindication for elective lumbar spine surgery
- •Pathologic fracture
- •Osteoporosis with pathologic fracture
- •Active systemic infection
- •Rheumatic disease
- •Disease of bone metabolism (e.g. Paget's Disease)
- •Bone metastasis
- •Local infection focus lumbar spine
- •Seizure disorder
- •Chronic ischemia Fontaine classification IIb-IV
- •Severe heart insufficiency (NYHA III-IV)
- •Blood coagulation disorder or blood thinning therapy
- •Cortisone intake more than one month in the last 12 months before randomization
- •Simultaneous participation in another clinical trial in the 30 days before randomization
- •Known allergy or intolerance to the implants
- •Dependency on investigator
- •Lack of familiarity with the German language
- •Placement in an institution by governmental or juridical advice
- •Absent legal capacity
- •Pregnancy
结局指标
主要结局
Changes in the subscores of physical pain and physical function in the ODI Questionaire
时间窗: Baseline to 6 month
次要结局
- MCS and individual dimensions and subscales of the SF-36™(60 Month)
研究者
Dr. Jan Siewe
Dr.med.
University of Cologne
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