RecruitingNot Applicable

Comparative Analysis of Two Transforaminal Lumbar Interbody Fusion (TLIF) Procedures in the Treatment of Single-Level Lumbar Spinal Stenosis (LSS): A Single-Center, Prospective, Randomized Controlled Trial

China276 participantsStarted 2026-03-18

Plain-language summary

Lumbar spinal stenosis (LSS), a common degenerative lumbar condition characterized by low back pain, leg pain, and neurogenic claudication, significantly impairs patients' quality of life. Its prevalence continues to rise with the aging population. For patients who do not respond to conservative treatment, surgical intervention remains a key therapeutic approach, with lumbar interbody fusion (LIF) being a commonly employed procedure. The technique has evolved from posterior lumbar interbody fusion (PLIF) to transforaminal lumbar interbody fusion (TLIF) and, more recently, to minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Although MIS-TLIF can effectively reduce tissue trauma and complications, it still faces clinical challenges such as intraoperative visual blind spots and the potential for postoperative chronic back pain associated with reliance on conventional pedicle screws. To address these limitations, our research team independently developed a highly integrated, miniaturized (with an outer diameter of only 1.8 mm), and maneuverable L-Unitary Soft Endoscope (LUSE) minimally invasive system. Its unique design helps avoid obstruction of the surgical field and allows flexible adjustment during the procedure. Currently, there is a lack of clinical efficacy evaluations in China on the use of this LUSE system for TLIF surgery (referred to as LUSE-TLIF) in treating LSS. Therefore, this study aims to systematically compare LUSE-TLIF with the currently mainstream MIS-TLIF, evaluating its safety, efficacy, and clinical outcomes in the treatment of LSS, in order to provide spine surgeons with a novel and potentially superior minimally invasive surgical option.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ranging from 40 to 70 years, irrespective of sex. * Presence of bilateral lower-limb pain and neurogenic claudication, with or without low back pain. * Preoperative computed tomography or magnetic resonance imaging confirming single-level lumbar spinal stenosis accompanied by grade II or higher lumbar spondylolisthesis and/or lumbar instability. * Persistent pain within 7 days prior to enrollment, with inadequate response to nonsurgical treatment for more than 3 months. * Willingness to provide written informed consent and ability to comply with the study protocol and visit schedule. Exclusion Criteria: * Patients with evidence of vascular claudication identified by lower-limb color Doppler ultrasound. * Patients with a history of previous lumbar spine surgery. * Coexistence of severe lumbar disc herniation, spinal deformity, spinal tumor, infection, or inflammatory diseases. * Pregnancy or lactation. * Presence of severe underlying medical conditions or psychiatric disorders that preclude tolerance of the procedure. * Known concurrent diseases considered by the investigator to preclude study entry. * Inability to comply with study assessments or complete questionnaires for any reason. * Patients deemed unsuitable for participation in this trial as judged by the investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vertebral Fushion

Timeframe: 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-operation

ODI

Timeframe: baseline, 3-day, 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-operation

Trial details

NCT IDNCT07588555

SponsorThe Third Affiliated Hospital of Southern Medical University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2031-12-31

Contact for this trial

Kaiting Chen, PhD

+86 020-62784332 1190011049@smu.edu.cn

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials