Comparative Analysis of Two Transforaminal Lumbar Interbody Fusion (TLIF) Procedures in th
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 int
| Condition(s) | Lumbar Spinal Stenosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 spo |
| Who can participate | 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. * |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Lead sponsor | The Third Affiliated Hospital of Southern Medical University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2026-03-18 |
| NCT ID | NCT07588555 |
| Official listing | https://clinicaltrials.gov/study/NCT07588555 |