NCT07279051

Modified Mini-Open TLIF vs Traditional Open TLIF

Modified Mini-Open TLIF Versus Traditional Open TLIF for Lumbar Spinal Stenosis : A Prospective, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: The First People's Hospital of Lianyungang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and walking difficulties caused by lumbar spinal stenosis with instability. The study will also look at the safety of both surgeries. It is designed to answer these main questions: Is the mMO-TLIF surgery as good as the traditional TLIF surgery at improving patients' lower back function and quality of life? Does the mMO-TLIF surgery reduce blood loss during the operation and shorten hospital stays and recovery time? What medical problems (like infections or nerve injuries) might patients experience after having the mMO-TLIF surgery? Researchers will compare the results of the mMO-TLIF surgery group with the traditional TLIF surgery group to see which one works better. Participants will: Be randomly assigned to receive either the mMO-TLIF minimally invasive surgery or the traditional TLIF open surgery. Come back to the hospital for check-ups before surgery, and then at 1 month, 3 months, 12 months and 24 months after surgery. During these check-ups, they will have physical exams, fill out questionnaires about their symptoms, dysfunction and quality of life, and get X-rays or CT scans to see how their bones are healing.

Conditions

• Spinal Stenosis Lumbar

Interventions

Type	Name	Description
PROCEDURE	modified mini-open transforaminal lumbar interbody fusion	The modified Mini-Open Transforaminal Lumbar Interbody Fusion (mMO-TLIF) is a hybrid technique that integrates minimally invasive and open concepts. Its core principle involves a limited open exposure on the decompression side for canal decompression and interbody fusion using retractors, while the non-decompression side undergoes pure percutaneous pedicle screw fixation, thereby maximally preserving the paraspinal muscles. This approach effectively balances surgical visualization with tissue preservation, achieving robust internal fixation while significantly reducing muscle injury, intraoperative blood loss, and enhancing surgical efficiency, making it particularly suitable for multi-level fusion.
PROCEDURE	traditional transforaminal lumbar interbody fusion	Traditional Transforaminal Lumbar Interbody Fusion (TLIF) is a classic posterior surgical approach for lumbar pathologies. It utilizes a posterior midline incision with extensive dissection and retraction of paraspinal muscles to achieve adequate exposure, allowing for discectomy, neural decompression, and interbody fusion through a unilateral transforaminal approach, typically supplemented with bilateral pedicle screw instrumentation. Advantages: Excellent surgical exposure and large working space facilitating thorough neural decompression and providing reliable spinal stability. Disadvantages: Extensive dissection of paraspinal soft tissues may lead to postoperative chronic muscle denervation and low back pain; associated with significant intraoperative blood loss and a prolonged recovery period.

Timeline

• Start date: 2025-12-06
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-12-12
• Last updated: 2025-12-12