Study Stopped
Patients did not consent to randomization in any study center, since they preferred endoscopic surgery. The recruitment of patients was impossible.
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
TESCORT
Transforaminal Endoscopic Surgery Cost Outcome Research Trial
1 other identifier
interventional
N/A
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2013
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2017
CompletedSeptember 25, 2017
September 1, 2017
3.3 years
June 12, 2012
September 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Oswestry Disability Index at 4 years
total follow-up period of 4 years
Secondary Outcomes (5)
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
Study Arms (2)
Endscopy
EXPERIMENTALMicrosurgery
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- symptomatic lumbar disc herniation
- clinical and radiological evidence of nerve root compression
- failure of conservative treatment for at least 6 weeks
You may not qualify if:
- previous lumbar spine surgery
- severe or progressive motor deficit
- BMI \> 40
- cauda equina syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joimax GmbHlead
Study Sites (3)
University Clinic of Neurosurgery
Graz, 8036, Austria
Ligamenta Spine Center
Frankfurt, 60594, Germany
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Heidelberg, 69118, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl H Fürstenberg, MD
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 19, 2012
Study Start
September 1, 2013
Primary Completion
January 1, 2017
Study Completion
September 22, 2017
Last Updated
September 25, 2017
Record last verified: 2017-09