跳至主要内容
临床试验/DRKS00025786
DRKS00025786招募中3 期

Full-Endoscopic versus conventional Microsurgical Therapy of Lumbar Disc Herniation: a prospective, controlled, single-center, comprehensive cohort trial (FEMT-LDH trial) - FEMT-LDH

Joimax GmbH0 个研究点目标入组 174 人开始时间: 2021年7月7日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
Joimax GmbH
入组人数
174

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • Patients for whom the medical indication for lumbar disc surgery is given and conservative therapy was unsuccessful
  • -Gender: male or female
  • -Minimum age: 18 years
  • -Maximum age: 75 years

排除标准

  • -Patients under 18 years of age
  • -Patients incapable of giving consent
  • -Patients who contact the Loretto Hospital in advance with the request of one of the two surgical methods (these patients will be assigned to the respective non-randomized group if they consent to participate in the study)
  • -Patients who do not agree to follow-up appointments 3 weeks, 1 year, 2 years and 5 years post-op
  • -Breastfeeding, pregnant or childbearing women who plan to become pregnant while participating in the study
  • -Massively sequestered disc prolapse
  • -Prolapse in the upper lumbar region (L2 or above)
  • -Patients with previous prolapse and revision surgery
  • -Prolapse affects several segments
  • -Patients = 120 kg
  • -Patients with an active infection process
  • -Patients with other serious, especially malignant, diseases
  • -Patients with other severe spinal disorders, such as osteoarthritis, osteopenia, osteoporosis or osteomalacia
  • -Patients with congenital malformations of the spine

研究者

发起方
Joimax GmbH

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