Lumbar Disc HerniationTESCORTNCT01622413
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
A study testing joimax TESSYS and Microdiscectomy in people with Lumbar Disc Herniation, run by Joimax GmbH at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- joimax TESSYS and Microdiscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2013to 22 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic lumbar disc herniation
- clinical and radiological evidence of nerve root compression
- failure of conservative treatment for at least 6 weeks
Who cannot join
- previous lumbar spine surgery
- severe or progressive motor deficit
- BMI > 40
- cauda equina syndrome
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Ligamenta Spine Center
Frankfurt, 60594
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
Heidelberg, 69118
About this study
Official title: Transforaminal Endoscopic Surgery Cost Outcome Research Trial
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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- joimax TESSYS, Microdiscectomy
- Keywords
- lumbar spine, herniated disc, slipped disc, disc herniation, discectomy, nucleotomy, disc surgery, endoscopy, spine
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joimax TESSYSProcedure or surgery
Also called TES, TESS
Transforaminal Endoscopic Surgery System
MicrodiscectomyProcedure or surgery
Standard procedure for disc surgery
| Study group | Role | What they receive |
|---|---|---|
| Endscopy | Experimental | Not described Receives: Procedure: joimax TESSYS |
| Microsurgery | Active comparator | Not described Receives: Procedure: Microdiscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Oswestry Disability Index at 4 years
Measured: total follow-up period of 4 years
Secondary outcomes (5)
Change from baseline in Quality of Life (SF-12)
Measured: total follow-up period of 4 years
Health resources consumption
Measured: total follow-up period of 4 years
Complication rate
Measured: 2 years
Patient satisfaction
Measured: Total follow-up period of 4 years
Change from baseline in back and leg pain (NRS)
Measured: total follow-up period of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startSep 2013
- Primary completionJan 2017 (estimated)
- Study completion22 Sep 2017
Why it stopped: Patients did not consent to randomization in any study center, since they preferred endoscopic surgery. The recruitment of patients was impossible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joimax GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl H Fürstenberg, MD, Principal investigator, University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622413
- Sponsor's protocol ID
- 2011/001
- Acronym
- TESCORT
- Status last verified
- Sep 2017
- First submitted
- 12 Jun 2012
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforaminal Endoscopic Surgery Cost Outcome Research Trial
- ClinicalTrials.gov ID
- NCT01622413
- Acronym / sponsor ID
- TESCORT / 2011/001
- Conditions
- Lumbar Disc Herniation
- Keywords
- lumbar spine, herniated disc, slipped disc, disc herniation, discectomy, nucleotomy, disc surgery, endoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients did not consent to randomization in any study center, since they preferred endoscopic surgery. The recruitment of patients was impossible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joimax GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- 22 Sep 2017 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endscopy | Experimental | Procedure: joimax TESSYS |
| Microsurgery | Active comparator | Procedure: Microdiscectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic lumbar disc herniation
- clinical and radiological evidence of nerve root compression
- failure of conservative treatment for at least 6 weeks
Key exclusion criteria (4 listed)
- previous lumbar spine surgery
- severe or progressive motor deficit
- BMI > 40
- cauda equina syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| joimax TESSYSAlso: TES, TESSTransforaminal Endoscopic Surgery System | Procedure or surgery | Endscopy |
| MicrodiscectomyStandard procedure for disc surgery | Procedure or surgery | Microsurgery |
Primary outcome
Change from baseline in Oswestry Disability Index at 4 years
Time frame: total follow-up period of 4 years
5 secondary outcomes
Change from baseline in Quality of Life (SF-12)
Time frame: total follow-up period of 4 years
Health resources consumption
Time frame: total follow-up period of 4 years
Complication rate
Time frame: 2 years
Patient satisfaction
Time frame: Total follow-up period of 4 years
Change from baseline in back and leg pain (NRS)
Time frame: total follow-up period of 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
Related trials for Lumbar Disc Herniation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl H Fürstenberg, MD principal investigator
University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joimax TESSYS and Microdiscectomy in people with Lumbar Disc Herniation, run by Joimax GmbH at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Oswestry Disability Index at 4 years (time frame: total follow-up period of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.