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

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ClinicalTrials.gov Identifier: NCT01622413
Recruitment Status : Withdrawn (Patients did not consent to randomization in any study center, since they preferred endoscopic surgery. The recruitment of patients was impossible.)
First Posted : June 19, 2012
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Joimax GmbH

Brief 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.


Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Procedure: joimax TESSYS Procedure: Microdiscectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transforaminal Endoscopic Surgery Cost Outcome Research Trial
Study Start Date : September 2013
Estimated Primary Completion Date : January 2017
Actual Study Completion Date : September 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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



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

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


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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

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

Responsible Party: Joimax GmbH
ClinicalTrials.gov Identifier: NCT01622413     History of Changes
Other Study ID Numbers: 2011/001
First Posted: June 19, 2012    Key Record Dates
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