Actively Recruiting
Comparative Analysis of L-Unitary Soft Endoscope Transforaminal Lumbar Interbody Fusion (LUSE-TLIF) Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS-TLIF) in the Treatment of Single-Level Lumbar Spinal Stenosis (LSS): A Single-Center, Prospective, Randomized Controlled Trial
Led by The Third Affiliated Hospital of Southern Medical University · Updated on 2026-05-14
276
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lumbar spinal stenosis (LSS) is a common degenerative condition causing low back pain, leg pain, and difficulty walking, which greatly reduces quality of life, especially in older adults. Surgical treatment is often needed when conservative methods fail. This trial compares a new minimally invasive surgical system called L-Unitary Soft Endoscope (LUSE) used in transforaminal lumbar interbody fusion (TLIF) surgery with the current standard minimally invasive TLIF (MIS-TLIF) to evaluate safety, effectiveness, and clinical results for single-level LSS. The study involves two groups: one undergoing TLIF surgery using the LUSE system, which features a small, flexible endoscope providing clearer surgical views and uses percutaneous pedicle screws to reduce muscle injury; the other group receives the standard MIS-TLIF surgery using the Quadrant retractor system and traditional open pedicle screws. The LUSE system aims to overcome visual blind spots and reduce postoperative chronic back pain risks. Both procedures are performed at a single center in a randomized, controlled design. Participants will be followed and assessed at multiple time points up to five years after surgery, including evaluations of spinal fusion, disability (Oswestry Disability Index), and pain (Visual Analog Scale). Additional measures include surgery time, blood loss, incision size, muscle condition, and imaging studies. Safety and clinical outcomes will be closely monitored to determine the comparative benefits of the LUSE system in treating lumbar spinal stenosis.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo either LUSE-TLIF or MIS-TLIF surgery for treatment of single-level lumbar spinal stenosis.
1 surgery day (in-person)
Duration - Up to 5 years
Participants are monitored for recovery, surgical outcomes, and safety after surgery.
Multiple visits at 3 days, 3 months, 6 months, 1 year, 2 years, 3 years, and 5 years post-operation
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 515000
Actively Recruiting
Research Team
K
Kaiting Chen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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