Back to resultsTrial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy (TESCORT)
Primary Purpose
Lumbar Disc Herniation
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
joimax TESSYS
Microdiscectomy
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring lumbar spine, herniated disc, slipped disc, disc herniation, discectomy, nucleotomy, disc surgery, endoscopy, spine
Eligibility Criteria
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
Sites / Locations
- University Clinic of Neurosurgery
- Ligamenta Spine Center
- University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endscopy
Microsurgery
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in Oswestry Disability Index at 4 years
Secondary Outcome Measures
Change from baseline in Quality of Life (SF-12)
Health resources consumption
Complication rate
Patient satisfaction
Change from baseline in back and leg pain (NRS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01622413
Brief Title
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
Acronym
TESCORT
Official Title
Transforaminal Endoscopic Surgery Cost Outcome Research Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Patients did not consent to randomization in any study center, since they preferred endoscopic surgery. The recruitment of patients was impossible.
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
September 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joimax GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
lumbar spine, herniated disc, slipped disc, disc herniation, discectomy, nucleotomy, disc surgery, endoscopy, spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endscopy
Arm Type
Experimental
Arm Title
Microsurgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
joimax TESSYS
Other Intervention Name(s)
TES, TESS
Intervention Description
Transforaminal Endoscopic Surgery System
Intervention Type
Procedure
Intervention Name(s)
Microdiscectomy
Intervention Description
Standard procedure for disc surgery
Primary Outcome Measure Information:
Title
Change from baseline in Oswestry Disability Index at 4 years
Time Frame
total follow-up period of 4 years
Secondary Outcome Measure Information:
Title
Change from baseline in Quality of Life (SF-12)
Time Frame
total follow-up period of 4 years
Title
Health resources consumption
Time Frame
total follow-up period of 4 years
Title
Complication rate
Time Frame
2 years
Title
Patient satisfaction
Time Frame
Total follow-up period of 4 years
Title
Change from baseline in back and leg pain (NRS)
Time Frame
total follow-up period of 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl H Fürstenberg, MD
Organizational Affiliation
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic of Neurosurgery
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ligamenta Spine Center
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
City
Heidelberg
ZIP/Postal Code
69118
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
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