Foraminal StenosisTLIFNCT06685575
Comparative Outcomes of Conventional TLIF With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery
A study testing Endoscopic Foraminotomy Surgery in people with Foraminal Stenosis, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Foraminal Stenosis
- What is being tested?
- Endoscopic Foraminotomy Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-80
- Persist radiculopathy and sciatica pain
- Patient that was diagnosed Stable lumbar foraminal stenosis
- Failed conservative for at least 6 months
- Patients who willing to join the study
Who cannot join
- Patients with unstable lumbar foraminal stenosis
- Patient with spine infection or tumor or fracture
- Patient with BMD less than -2.5 or osteopenia
- Patient with inflammatory joint diseases who on steroids
- Patient who has undergo with surgery that inserted metals in back
- Unable to answer questionnaires
- Cannot tolerate surgery due to severe medical comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
Read the detailed description
Backgrounds :
Lumbar foraminal stenosis is a condition in which a spinal nerve is entrapped in a narrow lumbar foramen in degenerative lumbar spinal disorders. The gold standard treatment of this condition has not been proposed yet. Several different techniques for this problem has been described, including foraminotomy, facetectomy, partial pediculectomy, fusion, and distraction instrumentation.Nowadays, due to the great advancement of the technology in endoscopy expanded the indication of endoscopic decompression from the central canal to the extraforaminal zone, Which was difficult to gain access from the mere microscope.
Objectives :
To compare outcomes between posterior decompression With conventional transforaminal lumbar interbody fusion (TLIF) and full-endoscopic foraminoplasty (FELF) in stable lumbar foraminal Stenosis
Methods :
This is an ambi-directional cohort study, In retrospective part conducted from JAN2019-JAN2024 in Queen Savang Vadhana Memorial Hospital and the prospective part conducted from AUG2024 - JUNE 2025, Thailand. 60 patients presented with stable lumbar foraminal stenosis were divided into posterior decompression with conventional transforaminal lumbar interbody fusion (TLIF) group ( N=30) and full-endoscopic lumbar foraminoplasty (FELF) group (N=30). Demographic data and pre-perioperative parameters were analyzed. For TLIF group , Standard procedure had been performed.
Posterior decompression, pedicle screws and interbody cage ( Mont blanc, Spineway, France) insertion under image intensifier ( BV Pulsera,Philips).For endoscopic foraminoplasty , uniportal stenoscope ( Vertebris ,Riwospine ) was used to perform endoscopic decompressive surgery. Post-operative outcome , for instance , Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) were recorded at preoperative, post-op day1, 3 month, 6 month and 1 year respectively. Other parameters such as estimated blood loss (EBL), length of hospital stay and post- operative complications were also recorded
- Conditions
- Foraminal Stenosis
- Being tested
- Endoscopic Foraminotomy Surgery
- Keywords
- Lumbar Foraminal Stenosis, endoscopic decompression surgery, Endoscopic Foraminotomy Surgery, TLIF in lumbar foraminal stenosis, stable lumbar foraminal stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Foraminotomy SurgeryProcedure or surgery
Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis
| Study group | Role | What they receive |
|---|---|---|
| Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery | No intervention | standard surgery for foraminal stenosis |
| Endoscopic Foraminotomy Surgery | Experimental | The new type of surgery to treat lumbar foraminal stenosis which does not lead to instability of the spine Receives: Procedure: Endoscopic Foraminotomy Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index (ODI) score post-operation at 12months
Oswestry disability index (ODI) questionnaire at 12 months postoperative. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly.
Measured: 12 months
Secondary outcomes (7)
Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months
Oswestry disability index (ODI) questionnaire at 6week, 3 months and 6 months. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly
Measured: 6week, 3 months and 6 months
visual analog scale (VAS) of pain both leg and back
visual analog scale (VAS) of pain.A Visual Analogue Scale (VAS) score is interpreted by measuring the distance from the "no pain" end of a 100-mm line to a mark made by the patient to indicate their pain level. A higher score indicates greater pain intensity.
Measured: 1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months
estimated blood loss (EBL)
intraoperative estimated blood loss (EBL) measure in milliliter. estimated blood loss is a reliable predictor of actual blood loss during orthopedic procedures.
Measured: perioperation
operative time
operative time measure in minutes, usually 60-90 minutes
Measured: perioperation
length of hospital stay
length of hospital stay
Measured: from 3 days to 1 week
time return to work
time return to work
Measured: through the study completion, an average of 1 year
postoperative complications
postoperative complications
Measured: through the study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Nov 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foraminal StenosisStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685575
- Sponsor's protocol ID
- 020/2567
- Acronym
- TLIF
- Status last verified
- Jun 2025
- First submitted
- 4 Nov 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data was save inform of microsoft excel spreadsheet and SPSS file
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
- ClinicalTrials.gov ID
- NCT06685575
- Acronym / sponsor ID
- TLIF / 020/2567
- Conditions
- Foraminal Stenosis
- Keywords
- Lumbar Foraminal Stenosis, endoscopic decompression surgery, Endoscopic Foraminotomy Surgery, TLIF in lumbar foraminal stenosis, stable lumbar foraminal stenosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- 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.
Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
Detailed description
Backgrounds :
Lumbar foraminal stenosis is a condition in which a spinal nerve is entrapped in a narrow lumbar foramen in degenerative lumbar spinal disorders. The gold standard treatment of this condition has not been proposed yet. Several different techniques for this problem has been described, including foraminotomy, facetectomy, partial pediculectomy, fusion, and distraction instrumentation.Nowadays, due to the great advancement of the technology in endoscopy expanded the indication of endoscopic decompression from the central canal to the extraforaminal zone, Which was difficult to gain access from the mere microscope.
Objectives :
To compare outcomes between posterior decompression With conventional transforaminal lumbar interbody fusion (TLIF) and full-endoscopic foraminoplasty (FELF) in stable lumbar foraminal Stenosis
Methods :
This is an ambi-directional cohort study, In retrospective part conducted from JAN2019-JAN2024 in Queen Savang Vadhana Memorial Hospital and the prospective part conducted from AUG2024 - JUNE 2025, Thailand. 60 patients presented with stable lumbar foraminal stenosis were divided into posterior decompression with conventional transforaminal lumbar interbody fusion (TLIF) group ( N=30) and full-endoscopic lumbar foraminoplasty (FELF) group (N=30). Demographic data and pre-perioperative parameters were analyzed. For TLIF group , Standard procedure had been performed.
Posterior decompression, pedicle screws and interbody cage ( Mont blanc, Spineway, France) insertion under image intensifier ( BV Pulsera,Philips).For endoscopic foraminoplasty , uniportal stenoscope ( Vertebris ,Riwospine ) was used to perform endoscopic decompressive surgery. Post-operative outcome , for instance , Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) were recorded at preoperative, post-op day1, 3 month, 6 month and 1 year respectively. Other parameters such as estimated blood loss (EBL), length of hospital stay and post- operative complications were also recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery | No intervention | –standard surgery for foraminal stenosis |
| Endoscopic Foraminotomy Surgery | Experimental | Procedure: Endoscopic Foraminotomy SurgeryThe new type of surgery to treat lumbar foraminal stenosis which does not lead to instability of the spine |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-80
- Persist radiculopathy and sciatica pain
- Patient that was diagnosed Stable lumbar foraminal stenosis
- Failed conservative for at least 6 months
- Patients who willing to join the study
Key exclusion criteria (7 listed)
- Patients with unstable lumbar foraminal stenosis
- Patient with spine infection or tumor or fracture
- Patient with BMD less than -2.5 or osteopenia
- Patient with inflammatory joint diseases who on steroids
- Patient who has undergo with surgery that inserted metals in back
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 |
|---|---|---|
| Endoscopic Foraminotomy SurgeryEndoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis | Procedure or surgery | Endoscopic Foraminotomy Surgery |
Primary outcome
Oswestry disability index (ODI) score post-operation at 12months
Time frame: 12 months
Oswestry disability index (ODI) questionnaire at 12 months postoperative. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly.
7 secondary outcomes
Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months
Time frame: 6week, 3 months and 6 months
visual analog scale (VAS) of pain both leg and back
Time frame: 1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months
estimated blood loss (EBL)
Time frame: perioperation
operative time
Time frame: perioperation
length of hospital stay
Time frame: from 3 days to 1 week
time return to work
Time frame: through the study completion, an average of 1 year
postoperative complications
Time frame: through the study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No. Data was save inform of microsoft excel spreadsheet and SPSS file
Related trials for Foraminal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Enrolling by invitation
Prospective Evaluation of Upright Versus Supine CT Myelography of the Lumbar Spine
Lumbar Central Canal Stenoses, Neural Foraminal Stenoses
Not yet recruiting
The Selective Intraperineural Nerve Root Block Study
Radiculopathy Lumbar, Radiculopathy Sacral
Active, not recruitingObservational study
Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
Radiculopathy, Myelopathy Cervical
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Foraminotomy Surgery in people with Foraminal Stenosis, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
This study is still under way. Results are not available in the source record yet.
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?
Oswestry disability index (ODI) score post-operation at 12months (time frame: 12 months). 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 13 Jun 2025.