Comparison of two TLIF procedures for single-level lumbar spinal stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized study conducted at a single center to compare two TLIF techniques for treating single-level lumbar spinal stenosis with accompanying instability or spondylolisthesis. Participants aged 40–70 who have persistent leg and/or back pain despite non-surgical care are randomized to receive either LUSE-TLIF or MIS-TLIF. Outcomes focus on safety, fusion success, pain relief, function, and recovery, using standard postoperative assessments over a defined follow-up period. The study aims to determine whether the minimally invasive approach offers advantages in reducing tissue trauma and improving outcomes compared with the alternative TLIF method. Recruitment is limited to patients meeting specific imaging and clinical criteria and who provide informed consent at the enrolling center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• The Third Affiliated Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Kaiting Chen, PhD
• Email: 1190011049@smu.edu.cn
• Phone: +86 020-62784332

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.