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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mMO-TLIF surgery group | Experimental | The experimental group (mMO-TLIF group) underwent modified Mini-Open Transforminal Lumbar Interbody Fusion, a procedure performed under general anesthesia via a posterior minimally invasive approach through the transforminal corridor. Key steps involved dilating the paraspinal musculature unilaterally with a retractor following exposure, subsequently performing pedicle screw insertion, decompression, and interbody cage placement, supplemented by contralateral percutaneous pedicle screw fixation. |
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| Traditional TLIF surgery group | Active Comparator | The traditional Open Transforminal Lumbar Interbody Fusion (TLIF) is a classic spinal surgical procedure. It is characterized by a long midline open incision, which requires extensive subperiosteal dissection and stripping of the paraspinal muscles to expose the bony anatomy. This approach provides a wide, direct surgical field, allowing for pedicle screw placement, neural decompression, and interbody fusion to be performed under direct visualization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified mini-open transforaminal lumbar interbody fusion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | preoperatively and 1/3/12/24 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | preoperatively and 1/3/12/24 months postoperatively |
| Zurich Claudication Questionnaire (ZCQ) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| You Lv | Contact | +86 18861301627 | gwykr@outlook.com |
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| traditional transforaminal lumbar interbody fusion | Procedure | 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. |
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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).
| 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. | 1/24 month postoperatively |
| Operative Time | Operative Time, measured in minutes | Immediately upon surgery conclusion |
| Intraoperative Blood Loss | Intraoperative Blood Loss, measured in milliliters | Immediately upon surgery conclusion |
| Transfusion Rate | From surgery start until hospital discharge, assessed up to 30 days. |
| Time to Ambulation | Time from surgery to first ambulation, assessed during postoperative hospital stay up to 30 days |
| Length of Hospital Stay | Length of hospital stay from surgery to discharge, assessed up to 30 days. |
| Incidence of complications | e.g., nerve injury, infection, screw loosening | From surgery start until 24 months postoperatively. |
| Radiographic fusion rate | Evaluated by CT (Bridwell classification) | 12 months postoperative |