Modified Mini-Open TLIF vs Traditional Open TLIF

The First People's Hospital of Lianyungang

Status: Not yet enrolling

Conditions: Spinal Stenosis Lumbar

Treatments: Procedure: modified mini-open transforaminal lumbar interbody fusion; Procedure: traditional transforaminal lumbar interbody fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07279051

KY-20250801001-02

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

224 participants in 2 patient groups

mMO-TLIF surgery group

Experimental group

Description:

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.

Treatment:

Procedure: modified mini-open transforaminal lumbar interbody fusion

Traditional TLIF surgery group

Active Comparator group

Description:

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.

Treatment:

Procedure: traditional transforaminal lumbar interbody fusion