Lumbar Disc Herniation
Conditions
Keywords
lumbar spine, herniated disc, slipped disc, disc herniation, discectomy, nucleotomy, disc surgery, endoscopy, spine
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.
Interventions
PROCEDUREjoimax TESSYS
Transforaminal Endoscopic Surgery System
PROCEDUREMicrodiscectomy
Standard procedure for disc surgery
Sponsors
Joimax GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Oswestry Disability Index at 4 years | total follow-up period of 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Quality of Life (SF-12) | total follow-up period of 4 years |
| Health resources consumption | total follow-up period of 4 years |
| Complication rate | 2 years |
| Patient satisfaction | Total follow-up period of 4 years |
| Change from baseline in back and leg pain (NRS) | total follow-up period of 4 years |
Countries
Austria, Germany
Outcome results
None listed