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

NCT07588555 | Recruiting DMC

• 2 other identifiers: LUSETLIFvsMISTLIFMR-44-26-026507
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosis; LUSE-TLIF; MISTLIF; Lumbar Spondylolisthesis; Lumbar Instability

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (10)

• VAS

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

• Surgery time

  within 24 hours after surgery

• Total blood loss

  within 24 hours after surgery

• postoperative drainage volume

  Within 24 hours after the subject is discharged

• incision length

  Within 24 hours after surgery

Study Arms (2)

LUSE-TLIF

EXPERIMENTAL

The subject underwent LUSE-TLIF surgery

Procedure: LUSE-TLIF

MIS-TLIF

ACTIVE COMPARATOR

Subjects underwent MIS-TLIF surgery assisted by the Quadrant channel

Procedure: MIS-TLIF

Interventions

LUSE-TLIF PROCEDURE

LUSE-TLIF is a TLIF procedure performed through the LUSE system.

Also known as: Experimental Group, 01

LUSE-TLIF

MIS-TLIF PROCEDURE

MIS-TLIF is a TLIF procedure performed through the Quadrant channel and other systems.

Also known as: Control group, 02

MIS-TLIF

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Southern Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 515000, China

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Kaiting Chen, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: This is a prospective, single-center, randomized, controlled clinical trial. Patients with lumbar spinal stenosis were screened according to the predefined inclusion and exclusion criteria and enrolled after providing written informed consent. Eligible participants were randomly assigned in a 1:1 ratio to either the LUSE-TLIF group or the MIS-TLIF group by a study nurse (who was not involved in patient recruitment, intervention delivery, or outcome assessment) using a computer-generated randomization scheme. Patients in the two groups underwent LUSE-TLIF or MIS-TLIF, respectively. General patient characteristics, perioperative data, radiographic parameters, and postoperative complications were recorded. The efficacy and safety of the two approaches were subsequently evaluated.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 14, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)