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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
224
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.
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.
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI), a 10-item questionnaire scored from 0 (no disability) to 100 (maximum disability), with higher scores indicating worse disability.
Time frame: preoperatively and 1/3/12/24 months postoperatively
Pain VAS scores
Pain Visual Analog Scale (VAS) score, ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating more severe pain.
Time frame: preoperatively and 1/3/12/24 months postoperatively
Zurich Claudication Questionnaire (ZCQ) score
Zurich Claudication Questionnaire (ZCQ) score, which includes symptom severity (range 1 to 5, lower scores indicate milder symptoms) and physical function (range 1 to 5, lower scores indicate less disability).
Time frame: Preoperative and 1/3/12 months postoperative
Brock Quality of Life Five Dimensions (EQ-5D-3L) questionnaire score
EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire score, ranging from -0.59 to 1.0, with higher scores indicating better quality of life.
Time frame: 1/24 month postoperatively
Operative Time
Operative Time, measured in minutes
Time frame: Immediately upon surgery conclusion
Intraoperative Blood Loss
Intraoperative Blood Loss, measured in milliliters
Time frame: Immediately upon surgery conclusion
Transfusion Rate
Time frame: From surgery start until hospital discharge, assessed up to 30 days.
Time to Ambulation
Time frame: Time from surgery to first ambulation, assessed during postoperative hospital stay up to 30 days
Length of Hospital Stay
Time frame: Length of hospital stay from surgery to discharge, assessed up to 30 days.
Incidence of complications
e.g., nerve injury, infection, screw loosening
Time frame: From surgery start until 24 months postoperatively.
Radiographic fusion rate
Evaluated by CT (Bridwell classification)
Time frame: 12 months postoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.