Trial record 9 of 35 for:    Open Studies | "Intervertebral Disk Displacement"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Joimax GmbH
Sponsor:
Information provided by (Responsible Party):
Joimax GmbH
ClinicalTrials.gov Identifier:
NCT01622413
First received: June 12, 2012
Last updated: July 26, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
  • 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 ]

Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Primary Completion Date: September 2018 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622413

Locations
Austria
University Clinic of Neurosurgery Not yet recruiting
Graz, Austria, 8036
Contact: Sandro Eustacchio, Univ Doz Dr. med.       Sandro.Eustacchio@klinikum-graz.at   
Germany
Ligamenta Spine Center Not yet recruiting
Frankfurt, Germany, 60594
Contact: Ralf Wagner, MD       ralf.wagner@ligamenta.de   
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology Not yet recruiting
Heidelberg, Germany, 69118
Contact: Carl H Fürstenberg, MD       carlhans.fuerstenberg@med.uni-heidelberg.de   
Sponsors and Collaborators
Joimax GmbH
Investigators
Principal Investigator: Carl H Fürstenberg, MD University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
  More Information

No publications provided

Responsible Party: Joimax GmbH
ClinicalTrials.gov Identifier: NCT01622413     History of Changes
Other Study ID Numbers: 2011/001
Study First Received: June 12, 2012
Last Updated: July 26, 2013
Health Authority: Germany: local ethics committee
Austria: local ethics committee

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

Additional relevant MeSH terms:
Hernia
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014