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NCT01622413 Clinical Trial

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

Lumbar Disc Herniation Clinical Trial

— TESCORT  

Official title:
Transforaminal Endoscopic Surgery Cost Outcome Research Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01622413
Other study ID # 2011/001
Secondary ID
Status Withdrawn
Phase N/A
First received June 12, 2012
Last updated September 22, 2017
Start date September 2013
Est. completion date September 22, 2017

Study information
Verified date September 2017
Source Joimax GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 22, 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• joimax TESSYS
Transforaminal Endoscopic Surgery System
• Microdiscectomy
Standard procedure for disc surgery

Locations
Country Name City State
Austria University Clinic of Neurosurgery Graz
Germany Ligamenta Spine Center Frankfurt
Germany University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Joimax GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Oswestry Disability Index at 4 years total follow-up period of 4 years
Secondary Change from baseline in Quality of Life (SF-12) total follow-up period of 4 years
Secondary Health resources consumption total follow-up period of 4 years
Secondary Complication rate 2 years
Secondary Patient satisfaction Total follow-up period of 4 years
Secondary Change from baseline in back and leg pain (NRS) total follow-up period of 4 years
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