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

September 22, 2017 updated by: Joimax GmbH

Transforaminal Endoscopic Surgery Cost Outcome Research Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • University Clinic of Neurosurgery
  • Germany
      • Frankfurt, Germany, 60594
        • Ligamenta Spine Center
      • Heidelberg, Germany, 69118
        • University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Endscopy
Procedure: joimax TESSYS
Transforaminal Endoscopic Surgery System
Other Names:
  • TES
  • TESS
ACTIVE_COMPARATOR: Microsurgery
Procedure: Microdiscectomy
Standard procedure for disc surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Oswestry Disability Index at 4 years
Time Frame: total follow-up period of 4 years
total follow-up period of 4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joimax GmbH

Investigators

  • Principal Investigator: Carl H Fürstenberg, MD, University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ACTUAL)

September 22, 2017

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (ESTIMATE)

June 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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