Spinal Stenosis LumbarTLIFNCT07279051
Modified Mini-Open TLIF vs Traditional Open TLIF
A study testing modified mini-open transforaminal lumbar interbody fusion and traditional transforaminal lumbar interbody fusion in people with Spinal Stenosis Lumbar, run by The First People's Hospital of Lianyungang.
Trial summary
This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- modified mini-open transforaminal lumbar interbody fusion and traditional transforaminal lumbar interbody fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2025to 1 May 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years.
- Presence of unilateral neurogenic claudication or radicular pain in the lower limbs, with failure to respond to at least 3 months of conservative treatment.
- Presence of bilateral neurogenic claudication or radicular pain in the lower limbs, but with complete resolution of neurological symptoms in at least one lower limb during recumbency and an unremarkable physical examination, alongside failure to respond to at least 3 months of conservative treatment.
- Radiologically confirmed single- or two-level lumbar spinal stenosis on MRI, with evidence of instability specifically at the stenotic level(s) on standing lateral radiographs.
- The mMO-TLIF or TLIF surgical procedure is performed by the same lead surgeon at each participating investigational site.
- Subjects voluntarily participate and provide written informed consent.
Who cannot join
- Presence of bilateral radicular pain in the lower limbs that does not completely resolve at rest.
- History of previous lumbar spine trauma or surgery.
- Presence of spinal infection, tuberculosis, or tumor.
- Contraindications to surgery, such as severe systemic medical diseases, coagulation disorders, severe active infectious diseases, or osteoporosis.
- Significant intervertebral space collapse, presence of bony ankylosis, etc.
- Incomplete data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Modified Mini-Open TLIF Versus Traditional Open TLIF for Lumbar Spinal Stenosis : A Prospective, Randomized Controlled Trial
This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and walking difficulties caused by lumbar spinal stenosis with instability. The study will also look at the safety of both surgeries.
It is designed to answer these main questions:
Read more
Is the mMO-TLIF surgery as good as the traditional TLIF surgery at improving patients' lower back function and quality of life? Does the mMO-TLIF surgery reduce blood loss during the operation and shorten hospital stays and recovery time? What medical problems (like infections or nerve injuries) might patients experience after having the mMO-TLIF surgery? Researchers will compare the results of the mMO-TLIF surgery group with the traditional TLIF surgery group to see which one works better.
Participants will:
Be randomly assigned to receive either the mMO-TLIF minimally invasive surgery or the traditional TLIF open surgery.
Come back to the hospital for check-ups before surgery, and then at 1 month, 3 months, 12 months and 24 months after surgery.
During these check-ups, they will have physical exams, fill out questionnaires about their symptoms, dysfunction and quality of life, and get X-rays or CT scans to see how their bones are healing.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- modified mini-open transforaminal lumbar interbody fusion, traditional transforaminal lumbar interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified mini-open transforaminal lumbar interbody fusionProcedure or surgery
The modified Mini-Open Transforaminal Lumbar Interbody Fusion (mMO-TLIF) is a hybrid technique that integrates minimally invasive and open concepts. Its core principle involves a limited open exposure on the decompression side for canal decompression and interbody fusion using retractors, while the non-decompression side undergoes pure percutaneous pedicle screw fixation, thereby maximally preserving the paraspinal muscles. This approach effectively balances surgical visualization with tissue preservation, achieving robust internal fixation while significantly reducing muscle injury, intraoperative blood loss, and enhancing surgical efficiency, making it particularly suitable for multi-level fusion.
traditional transforaminal lumbar interbody fusionProcedure or surgery
Traditional Transforaminal Lumbar Interbody Fusion (TLIF) is a classic posterior surgical approach for lumbar pathologies. It utilizes a posterior midline incision with extensive dissection and retraction of paraspinal muscles to achieve adequate exposure, allowing for discectomy, neural decompression, and interbody fusion through a unilateral transforaminal approach, typically supplemented with bilateral pedicle screw instrumentation.
Advantages: Excellent surgical exposure and large working space facilitating thorough neural decompression and providing reliable spinal stability.
Disadvantages: Extensive dissection of paraspinal soft tissues may lead to postoperative chronic muscle denervation and low back pain; associated with significant intraoperative blood loss and a prolonged recovery period.
| Study group | Role | What they receive |
|---|---|---|
| mMO-TLIF surgery group | Experimental | The experimental group (mMO-TLIF group) underwent modified Mini-Open Transforminal Lumbar Interbody Fusion, a procedure performed under general anesthesia via a posterior minimally invasive approach through the transforminal corridor. Key steps involved dilating the paraspinal musculature unilaterally with a retractor following exposure, subsequently performing pedicle screw insertion, decompression, and interbody cage placement, supplemented by contralateral percutaneous pedicle screw fixation. Receives: Procedure: modified mini-open transforaminal lumbar interbody fusion |
| Traditional TLIF surgery group | Active comparator | The traditional Open Transforminal Lumbar Interbody Fusion (TLIF) is a classic spinal surgical procedure. It is characterized by a long midline open incision, which requires extensive subperiosteal dissection and stripping of the paraspinal muscles to expose the bony anatomy. This approach provides a wide, direct surgical field, allowing for pedicle screw placement, neural decompression, and interbody fusion to be performed under direct visualization. Receives: Procedure: traditional transforaminal lumbar interbody fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI), a 10-item questionnaire scored from 0 (no disability) to 100 (maximum disability), with higher scores indicating worse disability.
Measured: preoperatively and 1/3/12/24 months postoperatively
Secondary outcomes (10)
Pain VAS scores
Pain Visual Analog Scale (VAS) score, ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating more severe pain.
Measured: preoperatively and 1/3/12/24 months postoperatively
Zurich Claudication Questionnaire (ZCQ) score
Zurich Claudication Questionnaire (ZCQ) score, which includes symptom severity (range 1 to 5, lower scores indicate milder symptoms) and physical function (range 1 to 5, lower scores indicate less disability).
Measured: Preoperative and 1/3/12 months postoperative
Brock Quality of Life Five Dimensions (EQ-5D-3L) questionnaire score
EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire score, ranging from -0.59 to 1.0, with higher scores indicating better quality of life.
Measured: 1/24 month postoperatively
Operative Time
Operative Time, measured in minutes
Measured: Immediately upon surgery conclusion
Intraoperative Blood Loss
Intraoperative Blood Loss, measured in milliliters
Measured: Immediately upon surgery conclusion
Transfusion Rate
Measured: From surgery start until hospital discharge, assessed up to 30 days.
Time to Ambulation
Measured: Time from surgery to first ambulation, assessed during postoperative hospital stay up to 30 days
Length of Hospital Stay
Measured: Length of hospital stay from surgery to discharge, assessed up to 30 days.
Incidence of complications
e.g., nerve injury, infection, screw loosening
Measured: From surgery start until 24 months postoperatively.
Radiographic fusion rate
Evaluated by CT (Bridwell classification)
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start6 Dec 2025 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279051
- Sponsor's protocol ID
- KY-20250801001-02
- Acronym
- TLIF
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Mini-Open TLIF Versus Traditional Open TLIF for Lumbar Spinal Stenosis : A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07279051
- Acronym / sponsor ID
- TLIF / KY-20250801001-02
- Conditions
- Spinal Stenosis Lumbar
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 6 Dec 2025 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 12 Dec 2025 (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.
This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and walking difficulties caused by lumbar spinal stenosis with instability. The study will also look at the safety of both surgeries.
It is designed to answer these main questions:
Is the mMO-TLIF surgery as good as the traditional TLIF surgery at improving patients' lower back function and quality of life? Does the mMO-TLIF surgery reduce blood loss during the operation and shorten hospital stays and recovery time? What medical problems (like infections or nerve injuries) might patients experience after having the mMO-TLIF surgery? Researchers will compare the results of the mMO-TLIF surgery group with the traditional TLIF surgery group to see which one works better.
Participants will:
Be randomly assigned to receive either the mMO-TLIF minimally invasive surgery or the traditional TLIF open surgery.
Come back to the hospital for check-ups before surgery, and then at 1 month, 3 months, 12 months and 24 months after surgery.
During these check-ups, they will have physical exams, fill out questionnaires about their symptoms, dysfunction and quality of life, and get X-rays or CT scans to see how their bones are healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mMO-TLIF surgery group | Experimental | Procedure: modified mini-open transforaminal lumbar interbody fusionThe experimental group (mMO-TLIF group) underwent modified Mini-Open Transforminal Lumbar Interbody Fusion, a procedure performed under general anesthesia via a posterior minimally invasive approach through the transforminal corridor. Key steps involved dilating the paraspinal musculature unilaterally with a retractor following exposure, subsequently performing pedicle screw insertion, decompression, and interbody cage placement, supplemented by contralateral percutaneous pedicle screw fixation. |
| Traditional TLIF surgery group | Active comparator | Procedure: traditional transforaminal lumbar interbody fusionThe traditional Open Transforminal Lumbar Interbody Fusion (TLIF) is a classic spinal surgical procedure. It is characterized by a long midline open incision, which requires extensive subperiosteal dissection and stripping of the paraspinal muscles to expose the bony anatomy. This approach provides a wide, direct surgical field, allowing for pedicle screw placement, neural decompression, and interbody fusion to be performed under direct visualization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged between 18 and 80 years.
- Presence of unilateral neurogenic claudication or radicular pain in the lower limbs, with failure to respond to at least 3 months of conservative treatment.
- Presence of bilateral neurogenic claudication or radicular pain in the lower limbs, but with complete resolution of neurological symptoms in at least one lower limb during recumbency and an unremarkable physical examination, alongside failure to respond to at least 3 months of conservative treatment.
- Radiologically confirmed single- or two-level lumbar spinal stenosis on MRI, with evidence of instability specifically at the stenotic level(s) on standing lateral radiographs.
- The mMO-TLIF or TLIF surgical procedure is performed by the same lead surgeon at each participating investigational site.
Key exclusion criteria (6 listed)
- Presence of bilateral radicular pain in the lower limbs that does not completely resolve at rest.
- History of previous lumbar spine trauma or surgery.
- Presence of spinal infection, tuberculosis, or tumor.
- Contraindications to surgery, such as severe systemic medical diseases, coagulation disorders, severe active infectious diseases, or osteoporosis.
- Significant intervertebral space collapse, presence of bony ankylosis, etc.
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 |
|---|---|---|
| modified mini-open transforaminal lumbar interbody fusionThe modified Mini-Open Transforaminal Lumbar Interbody Fusion (mMO-TLIF) is a hybrid technique that integrates minimally invasive and open concepts. Its core principle involves a limited open exposure on the decompression side for canal decompression and interbody fusion using retractors, while the non-decompression side undergoes pure percutaneous pedicle screw fixation, thereby maximally preserving the paraspinal muscles. This approach effectively balances surgical visualization with tissue preservation, achieving robust internal fixation while significantly reducing muscle injury, intraoperative blood loss, and enhancing surgical efficiency, making it particularly suitable for multi-level fusion. | Procedure or surgery | mMO-TLIF surgery group |
| traditional transforaminal lumbar interbody fusionTraditional Transforaminal Lumbar Interbody Fusion (TLIF) is a classic posterior surgical approach for lumbar pathologies. It utilizes a posterior midline incision with extensive dissection and retraction of paraspinal muscles to achieve adequate exposure, allowing for discectomy, neural decompression, and interbody fusion through a unilateral transforaminal approach, typically supplemented with bilateral pedicle screw instrumentation. Advantages: Excellent surgical exposure and large working space facilitating thorough neural decompression and providing reliable spinal stability. Disadvantages: Extensive dissection of paraspinal soft tissues may lead to postoperative chronic muscle denervation and low back pain; associated with significant intraoperative blood loss and a prolonged recovery period. | Procedure or surgery | Traditional TLIF surgery group |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: preoperatively and 1/3/12/24 months postoperatively
Oswestry Disability Index (ODI), a 10-item questionnaire scored from 0 (no disability) to 100 (maximum disability), with higher scores indicating worse disability.
10 secondary outcomes
Pain VAS scores
Time frame: preoperatively and 1/3/12/24 months postoperatively
Zurich Claudication Questionnaire (ZCQ) score
Time frame: Preoperative and 1/3/12 months postoperative
Brock Quality of Life Five Dimensions (EQ-5D-3L) questionnaire score
Time frame: 1/24 month postoperatively
Operative Time
Time frame: Immediately upon surgery conclusion
Intraoperative Blood Loss
Time frame: Immediately upon surgery conclusion
Transfusion Rate
Time frame: From surgery start until hospital discharge, assessed up to 30 days.
Time to Ambulation
Time frame: Time from surgery to first ambulation, assessed during postoperative hospital stay up to 30 days
Length of Hospital Stay
Time frame: Length of hospital stay from surgery to discharge, assessed up to 30 days.
Incidence of complications
Time frame: From surgery start until 24 months postoperatively.
Radiographic fusion rate
Time frame: 12 months postoperative
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 12 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing modified mini-open transforaminal lumbar interbody fusion and traditional transforaminal lumbar interbody fusion in people with Spinal Stenosis Lumbar, run by The First People's Hospital of Lianyungang.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact You Lv (+86 18861301627, gwykr@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: preoperatively and 1/3/12/24 months postoperatively). 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 12 Dec 2025.