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Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy

NCT01622413 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-09-25

No results posted yet for this study

Summary

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.

Conditions

  • Lumbar Disc Herniation

Interventions

PROCEDURE

joimax TESSYS

Transforaminal Endoscopic Surgery System

PROCEDURE

Microdiscectomy

Standard procedure for disc surgery

Sponsors & Collaborators

  • Joimax GmbH

    lead INDUSTRY

Principal Investigators

  • Carl H Fürstenberg, MD · University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-01-31
Completion
2017-09-22

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622413 on ClinicalTrials.gov