An interventional study of LUSE-TLIF and MIS-TLIF in Lumbar Spinal Stenosis, sponsored by The Third Affiliated Hospital of Southern Medical University. Recruiting at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by The Third Affiliated Hospital of Southern Medical University · Not applicable, Interventional, and Treatment
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.
Lumbar spinal stenosis (LSS) is a common degenerative condition of the lumbar spine. In its narrow definition, LSS primarily refers to central canal stenosis resulting from facet joint hypertrophy and thickening of the ligamentum flavum. Broadly, it also encompasses lateral recess stenosis and bony stenosis within the intervertebral foramen region, categories that some scholars group under lateral canal stenosis. The main symptoms of LSS include low back pain, leg pain, and neurogenic claudication, which impair patients' quality of life and severely limit function, particularly in the elderly. With the aging global population, the prevalence of LSS is rising, affecting approximately 103 million patients worldwide. Treatment options for LSS include both conservative and surgical management. Conservative treatments encompass medication, physical therapy, and lifestyle modifications. However, surgical intervention may be necessary for LSS patients who do not respond adequately to conservative therapies.
Lumbar interbody fusion (LIF) is commonly employed to treat various spinal pathologies, particularly lumbar spinal stenosis. Currently, LIF can be performed via open or minimally invasive approaches, including transforaminal, posterior, anterior, and lateral routes, each with its own advantages and disadvantages. Generally, posterior lumbar interbody fusion (PLIF) is a well-established procedure associated with good fusion rates and relatively low complication rates. However, it carries the risk of iatrogenic injury to neural structures and paraspinal muscles. Despite demonstrating favorable early outcomes, PLIF has notable limitations, including a relatively high complication rate and a challenging recovery process. In 1982, transforaminal lumbar interbody fusion (TLIF) was introduced, which offers a less traumatic and safer unilateral interbody fusion technique. TLIF addresses several shortcomings of PLIF, leading to its rapid adoption and continuous refinement within the spine surgery community. Nevertheless, traditional open TLIF faces challenges such as significant tissue trauma, potential muscle atrophy, chronic postoperative low back pain, and adjacent segment instability.
The advent of various minimally invasive techniques has helped reduce muscle injury and irritation to the posterior spinal elements. To minimize surgical trauma and facilitate rapid recovery, minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) was developed. A meta-analysis published in 2017 reported that MIS-TLIF could lower postoperative complication rates compared to conventional open procedures. Furthermore, MIS-TLIF demonstrates significant efficacy in protecting muscles (e.g., the multifidus) and ligaments. A comparative study indicated that the rates of postoperative complications and reoperations at 2-year and 3-year follow-ups were significantly lower for MIS-TLIF than for traditional TLIF. However, despite the improved visualization provided by the endoscope in MIS-TLIF, visual blind spots may still exist in certain complex anatomical areas, potentially leading to incomplete assessment of the pathological site and suboptimal placement of internal fixation devices. Additionally, MIS-TLIF relies on traditional open pedicle screw fixation, which may increase the long-term risk of postoperative chronic low back pain.
To address the aforementioned clinical challenges, our research team independently developed a L-Unitary Soft Endoscope minimally invasive system, termed LUSE (Chinese National Invention Patent: CN117017466B). It completed filing as a Class I medical device with the Guangzhou Market Supervision Administration in 2021 (Filing No.: 20210598) and is classified as a set of fundamental orthopedic surgical instruments, with its filing status remaining valid. The system features a highly integrated, all-in-one design that combines key components such as the display, camera, light source, and transmission system into a single unit, simplifying operation and maintenance. During development, particular attention was paid to controlling the size and weight of the endoscope, resulting in a compact and lightweight soft endoscope with a diameter of 1.8 mm and a length of 2-4 cm. Its volume and weight are reduced by approximately 93% compared to traditional endoscopes. This endoscope integrates multiple functions including illumination, imaging, and recording, significantly enhancing procedural convenience and patient comfort.
Compared to the traditional MIS-TLIF performed under a Quadrant expandable retractor system, the highly integrated LUSE system offers several advantages in lumbar minimally invasive fusion surgery: (1) The LUSE system supports 8K ultra-high-definition imaging, providing clear and detailed visualization of the surgical field, whereas the Quadrant retractor system only provides illumination without endoscopic magnification, limiting the ability to visualize fine anatomical structures; (2) LUSE-TLIF utilizes a percutaneous pedicle screw system, minimizing injury to the lumbar back muscles, ligaments, and blood vessels. In contrast, MIS-TLIF requires the placement of pedicle screws via a traditional open approach, which may increase the long-term incidence of chronic back pain; (3) The soft lens of the LUSE system offers 360-degree flexibility, whereas the Quadrant retractor system has inherent visual blind spots that can hinder adequate decompression and optimal implant placement. Therefore, LUSE-TLIF holds multiple advantages over MIS-TLIF. Our team has previously demonstrated the safety and efficacy of the LUSE system in anterior cervical discectomy and fusion (ACDF) and artificial disc replacement (ADR) procedures, with related studies published in leading Chinese journals such as the Chinese Journal of Orthopaedicsand the Chinese Journal of Spine and Spinal Cord. However, there is currently a lack of clinical research in China evaluating the efficacy of LUSE-TLIF for treating LSS. Consequently, this study aims to apply LUSE-TLIF for LSS treatment, observe its safety, efficacy, and clinical outcomes, and conduct a comparative analysis with MIS-TLIF, with the goal of providing spine surgeons with an additional and potentially superior surgical option.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 276 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →The Third Affiliated Hospital of Southern Medical University is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subject underwent LUSE-TLIF surgery
Procedure: LUSE-TLIF
Subjects underwent MIS-TLIF surgery assisted by the Quadrant channel
Procedure: MIS-TLIF
LUSE-TLIF is a TLIF procedure performed through the LUSE system.
Also known as: Experimental Group, 01
MIS-TLIF is a TLIF procedure performed through the Quadrant channel and other systems.
Also known as: Control group, 02
Vertebral Fushion
Assess vertebral fusion status through imaging indicators and clinical symptoms. Vertebral fusion was established as the clinical outcome, defined as: (1) Clinical fusion: a. absence of mechanical low back pain and intermittent claudication; b. dynamic flexion-extension radiographs demonstrating motion angle of the surgical segment less than 4°; (2) Bony fusion: a. Bridwell grade A or B; b. increase in segmental lordosis angle of the surgical segment ≥3° compared to baseline; (3) simultaneous achievement of both clinical and bony fusion.
Time frame: 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-operation
ODI
The ODI score refers to the Oswestry Disability Index, a widely used questionnaire that measures the level of disability in individuals with low back pain. It consists of ten sections assessing daily activities, with scores ranging from 0 to 100; higher scores indicate more severe disability.
Time frame: baseline, 3-day, 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-operation
VAS
The VAS score refers to the Visual Analogue Scale, a tool used to measure leg and back pain intensity. Patients mark a point on a 10-cm line, where one end represents "no pain" (0) and the other "worst imaginable pain" (10). The distance from the zero point gives the score, providing a simple, quick measure of symptom severity.
Time frame: baseline, 3-day, 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-operation
Surgery time
The surgery duration is recorded according to the time in the surgical document, with the unit in minutes.
Time frame: within 24 hours after surgery
Total blood loss
Collect the patient's height (m), weight (kg), hematocrit levels one day before and one day after surgery, and calculate the total blood loss (mL) using the Gross equation and Nadler formula.
Time frame: within 24 hours after surgery
postoperative drainage volume
The total drainage volume (mL) will be recorded by a ward nurse who is unaware of the study
Time frame: Within 24 hours after the subject is discharged
incision length
The incision length (cm) will be measured by a surgical nurse who is unaware of the study.
Time frame: Within 24 hours after surgery
surgical costs
Hospitalization costs (yuan/¥) will be calculated by a nurse who is unaware of the study, based on hospital system records.
Time frame: Within 24 hours after the subject is discharged
intraoperative blood loss
Intraoperative blood loss was recorded by a nurse who was unaware of this study, including blood in the drains and in the gauze, measured in mL.
Time frame: within 24 hours after surgery
Other lumbar spine imaging indicators
Measurement of dural sac cross-sectional area, lumbar spondylolisthesis rate, Cobb angle, average intervertebral disc height, and other parameters using X-ray, CT, and MRI.
Time frame: baseline, 3-day, 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-operation
Condition of paraspinal muscles
MRI measures paraspinal muscle area and fat infiltration rate by analyzing cross-sectional images from the lumbar spine.
Time frame: baseline, 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-operation
Muscle injury
CK (creatine kinase) and CK-MB are blood biomarkers used to assess muscle damage after lumbar fusion surgery
Time frame: 1 day before surgery, 1 day and 3 days after surgery
Plan to share: Yes — Study Protocol, Statistical Analysis Plan, Informed Consent Form
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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The Third Affiliated Hospital of Southern Medical University