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

This study has been withdrawn prior to enrollment.
(Patients did not consent to randomization in any study center, since they preferred endoscopic surgery. The recruitment of patients was impossible.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01622413
First Posted: June 19, 2012
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joimax GmbH
  Purpose

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.


Condition Intervention
Lumbar Disc Herniation Procedure: joimax TESSYS Procedure: Microdiscectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transforaminal Endoscopic Surgery Cost Outcome Research Trial

Resource links provided by NLM:


Further study details as provided by Joimax GmbH:

Primary Outcome Measures:
  • Change from baseline in Oswestry Disability Index at 4 years [ Time Frame: total follow-up period of 4 years ]

Secondary Outcome Measures:
  • Change from baseline in Quality of Life (SF-12) [ Time Frame: total follow-up period of 4 years ]
  • Health resources consumption [ Time Frame: total follow-up period of 4 years ]
  • Complication rate [ Time Frame: 2 years ]
  • Patient satisfaction [ Time Frame: 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 ]

Enrollment: 0
Study Start Date: September 2013
Study Completion Date: September 22, 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endscopy Procedure: joimax TESSYS
Transforaminal Endoscopic Surgery System
Other Names:
  • TES
  • TESS
Active Comparator: Microsurgery Procedure: Microdiscectomy
Standard procedure for disc surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622413


Locations
Austria
University Clinic of Neurosurgery
Graz, Austria, 8036
Germany
Ligamenta Spine Center
Frankfurt, Germany, 60594
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Heidelberg, Germany, 69118
Sponsors and Collaborators
Joimax GmbH
Investigators
Principal Investigator: Carl H Fürstenberg, MD University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
  More Information

Responsible Party: Joimax GmbH
ClinicalTrials.gov Identifier: NCT01622413     History of Changes
Other Study ID Numbers: 2011/001
First Submitted: June 12, 2012
First Posted: June 19, 2012
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Joimax GmbH:
lumbar spine
herniated disc
slipped disc
disc herniation
discectomy
nucleotomy
disc surgery
endoscopy
spine

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical