Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Neck Pain and Disability Scale (NPDS) between the two groups
研究概览
简要总结
Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain.
The goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Symptomatic cervical disc degenerative pathologies to 1 or more contiguous or non-contiguous levels C3-4 to C6-
- •Symptoms including: Cervicobrachial neuralgia and / or Loss of root muscle strength and / or Sensory impairment and paresthesia and / or Cervical myelopathy table
- •Concordant diagnosis confirmed by CT (Computerized Tomography scanner) and MRI (Magnetic Resonance Imaging) of the cervical spine
- •NPDS (Neck Pain and Disability Scale) > 30
- •Failure to respond to conservative medical treatment for 6 weeks or worsening symptoms despite conservative treatment
- •Physical and mental fitness to ensure compliance with the protocol
- •Signed informed consent
排除标准
- •Unstable cervical spine injuries requiring fusion C1 to C7 for whatever the etiology, proven on dynamic views of the cervical spine
- •Paget's disease, osteomalacia, other metabolic bone diseases
- •Chronic corticosteroid use
- •Active tumor pathology
- •Segmental angulation < -11 ° or > 11 ° at the respective segment or adjacent segments on static images of the cervical spine
- •Known allergy to Chromium, Cobalt, Mobdylene (chemical element), Polyethylene, or Titanium
- •History of surgery in the previous 30 days before inclusion
- •History of mental illness or disability involving a "safeguard procedure justice of the person"
- •Contraindications to non steroidal anti inflammatory
研究组 & 干预措施
Movable Core
Cervical arthroplasty with movable core prothesis
干预措施: Mobi-C prothesis (Device)
Fixed Core
Cervical arthroplasty with fixed core prothesis
干预措施: ProDisc-C prothesis (Device)
结局指标
主要结局
Neck Pain and Disability Scale (NPDS) between the two groups
时间窗: 2 years
Neck Pain and Disability Scale (NPDS) between the two groups
时间窗: Baseline
Neck Pain and Disability Scale (NPDS) between the two groups
时间窗: 3 months
Neck Pain and Disability Scale (NPDS) between the two groups
时间窗: 1 year
次要结局
未报告次要终点