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

Recruiting now · Not applicable

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID: NCT07588555
Run by: The Third Affiliated Hospital of Southern Medical University
People needed: 276
Starts: 2026-03-18
Expected to finish: 2031-12-31
Last updated by the study team: 2026-05-14

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

The Third Affiliated Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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