Comparing L-Unitary Soft Endoscope LUSE and Minimally Invasive Transforaminal Lumbar Interbody Fusion MIS-TLIF for Single-Level Lumbar Spinal Stenosis in Adults Aged 40 to 70

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.

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