跳至主要内容
临床试验/NL-OMON36245
NL-OMON36245已完成4 期

Clinical Study of the Valeo OL Interbody Fusion Device for Posterior Lumbar Interbody fusion versus PEEK: the Silicon Nitride and PEEK (SNAP) trial. - Silicon Nitride and PEEK (SNAP) trial

Amedica Corporation0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • _Subjects must be 18-75 years old.
  • _ at least 6 months of back pain/leg pain
  • _Grade 3 or higher disc degeneration on the MRI (by the Pfirrmann classification) with or without nerve root compression

排除标准

  • Osteoporosis
  • Patients with prior failed fusion at the same level
  • Degenerative scoliosis
  • Degenerative spondylolisthesis greater than Grade II
  • Psychiatric or mental disease
  • Alcoholism (drinking more than 5 units per day)
  • Active infection or prior infection at the surgical site
  • Active cancer
  • Insufficient language skills to complete questionnaires
  • Participation in another study
  • More than two symptomatic levels that need fusion

研究者

发起方
Amedica Corporation

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