Modified Mini-Open TLIF vs Traditional Open TLIF (TLIF)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Spinal Stenosis Lumbar
• Intervention / Treatment: Procedure: modified mini-open transforaminal lumbar interbody fusion; Procedure: traditional transforaminal lumbar interbody fusion

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: You Lv; Phone Number: +86 18861301627; Email: gwykr@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged between 18 and 80 years.
• Presence of unilateral neurogenic claudication or radicular pain in the lower limbs, with failure to respond to at least 3 months of conservative treatment.
• Presence of bilateral neurogenic claudication or radicular pain in the lower limbs, but with complete resolution of neurological symptoms in at least one lower limb during recumbency and an unremarkable physical examination, alongside failure to respond to at least 3 months of conservative treatment.
• Radiologically confirmed single- or two-level lumbar spinal stenosis on MRI, with evidence of instability specifically at the stenotic level(s) on standing lateral radiographs.
• The mMO-TLIF or TLIF surgical procedure is performed by the same lead surgeon at each participating investigational site.
• Subjects voluntarily participate and provide written informed consent.

Exclusion Criteria:

• Presence of bilateral radicular pain in the lower limbs that does not completely resolve at rest.
• History of previous lumbar spine trauma or surgery.
• Presence of spinal infection, tuberculosis, or tumor.
• Contraindications to surgery, such as severe systemic medical diseases, coagulation disorders, severe active infectious diseases, or osteoporosis.
• Significant intervertebral space collapse, presence of bony ankylosis, etc.
• Incomplete data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mMO-TLIF surgery group; 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.	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.
Active Comparator: Traditional TLIF surgery group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The First People's Hospital of Lianyungang

Study record dates

Study Major Dates

• Study Start (Estimated): December 6, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KY-20250801001-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No