临床试验/NCT01622413

NCT01622413撤回不适用

Transforaminal Endoscopic Surgery Cost Outcome Research Trial

Joimax GmbH6 个研究点分布在 2 个国家开始时间: 2013年9月最近更新: 2017年9月25日

适应症

干预措施

试验速览

阶段: 不适用
状态: 撤回
发起方: Joimax GmbH
试验地点: 6
主要终点: Change from baseline in Oswestry Disability Index at 4 years

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. Clinical parameters as well as health economy will be assessed.

The study hypothesis is that the endoscopic approach is equivalent or superior to microdiscectomy.

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: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•symptomatic lumbar disc herniation
•clinical and radiological evidence of nerve root compression
•failure of conservative treatment for at least 6 weeks

排除标准

•previous lumbar spine surgery
•severe or progressive motor deficit
•BMI > 40
•cauda equina syndrome

研究组 & 干预措施

Endscopy

Experimental

干预措施: joimax TESSYS (Procedure)

Microsurgery

Active Comparator

干预措施: Microdiscectomy (Procedure)

结局指标

主要结局

Change from baseline in Oswestry Disability Index at 4 years

时间窗: total follow-up period of 4 years

次要结局

Change from baseline in Quality of Life (SF-12)(total follow-up period of 4 years)
Change from baseline in back and leg pain (NRS)(total follow-up period of 4 years)
Health resources consumption(total follow-up period of 4 years)
Complication rate(2 years)
Patient satisfaction(Total follow-up period of 4 years)

研究者

发起方

Joimax GmbH

申办方类型

Industry

责任方

Sponsor

研究点 (6)

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