Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
Not Applicable
Withdrawn
- Conditions
- Lumbar Disc Herniation
- Interventions
- Procedure: joimax TESSYSProcedure: Microdiscectomy
- Registration Number
- NCT01622413
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endscopy joimax TESSYS - Microsurgery Microdiscectomy -
- Primary Outcome Measures
Name Time Method Change from baseline in Oswestry Disability Index at 4 years total follow-up period of 4 years
- Secondary Outcome Measures
Name Time Method Complication rate 2 years Change from baseline in Quality of Life (SF-12) total follow-up period of 4 years Change from baseline in back and leg pain (NRS) total follow-up period of 4 years Health resources consumption total follow-up period of 4 years Patient satisfaction Total follow-up period of 4 years
Trial Locations
- Locations (3)
University Clinic of Neurosurgery
🇦🇹Graz, Austria
Ligamenta Spine Center
🇩🇪Frankfurt, Germany
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
🇩🇪Heidelberg, Germany