Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
NCT ID: NCT01622413
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-09-30
2017-09-22
Brief Summary
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The study hypothesis is that the endoscopic approach is equivalent or superior to microdiscectomy.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endscopy
joimax TESSYS
Transforaminal Endoscopic Surgery System
Microsurgery
Microdiscectomy
Standard procedure for disc surgery
Interventions
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joimax TESSYS
Transforaminal Endoscopic Surgery System
Microdiscectomy
Standard procedure for disc surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clinical and radiological evidence of nerve root compression
* failure of conservative treatment for at least 6 weeks
Exclusion Criteria
* severe or progressive motor deficit
* BMI \> 40
* cauda equina syndrome
18 Years
80 Years
ALL
No
Sponsors
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Joimax GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Carl H Fürstenberg, MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Locations
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University Clinic of Neurosurgery
Graz, , Austria
Ligamenta Spine Center
Frankfurt, , Germany
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Heidelberg, , Germany
Countries
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Other Identifiers
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2011/001
Identifier Type: -
Identifier Source: org_study_id