The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in the health-related outcome measurement instruments (SF-36)
研究概览
简要总结
The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.
详细描述
Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO).
Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Legal capacity
- •Age ≥ 18 years
- •Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III 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 or >Pfirrmann grade IV
- •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
研究组 & 干预措施
Group 1
patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.).
干预措施: Dynesys DTO device (Zimmer Spine, Inc.) (Device)
Group 2
patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.).
干预措施: Dynesys DTO device (Zimmer Spine, Inc.) (Device)
Group 3
patients with the medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment receive the Dynesys DTO device (Zimmer Spine, Inc.).
干预措施: Dynesys DTO device (Zimmer Spine, Inc.) (Device)
结局指标
主要结局
Changes in the health-related outcome measurement instruments (SF-36)
时间窗: 24-48 months
Changes in the health-related outcome measurement instruments (COMI)
时间窗: 24-48 months
Changes in the health-related outcome measurement instruments (ODI)
时间窗: 24-48 months
Radiological outcomes
时间窗: 24-48 months
Radiological changes within the adjacent segment
次要结局
- Patient-related complication(24- 48 months)
- Device complication (breakage, loosening, etc.)(24 - 48 months)
研究者
Christian Herren
Principal Investigator
University Hospital, Aachen