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.
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.
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.
Parallel
LUSE-TLIF
Procedure/SurgeryLUSE-TLIF is a TLIF procedure performed through the LUSE system.
MIS-TLIF
Procedure/SurgeryMIS-TLIF is a TLIF procedure performed through the Quadrant channel and other systems.
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.
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.
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.
Surgery time
The surgery duration is recorded according to the time in the surgical document, with the unit in minutes.
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.
postoperative drainage volume
The total drainage volume (mL) will be recorded by a ward nurse who is unaware of the study
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