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NCT Number: NCT07279051

Modified Mini-Open TLIF vs Traditional Open TLIF

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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Key information

Conditions

Spinal Stenosis Lumbar

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: preoperatively and 1/3/12/24 months postoperatively

    Oswestry Disability Index (ODI), a 10-item questionnaire scored from 0 (no disability) to 100 (maximum disability), with higher scores indicating worse disability.

Secondary outcomes

  1. Pain VAS scores

    Time frame: preoperatively and 1/3/12/24 months postoperatively

    Pain Visual Analog Scale (VAS) score, ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating more severe pain.

  2. Zurich Claudication Questionnaire (ZCQ) score

    Time frame: Preoperative and 1/3/12 months postoperative

    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).

  3. Brock Quality of Life Five Dimensions (EQ-5D-3L) questionnaire score

    Time frame: 1/24 month postoperatively

    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.

  4. Operative Time

    Time frame: Immediately upon surgery conclusion

    Operative Time, measured in minutes

  5. Intraoperative Blood Loss

    Time frame: Immediately upon surgery conclusion

    Intraoperative Blood Loss, measured in milliliters

  6. Transfusion Rate

    Time frame: From surgery start until hospital discharge, assessed up to 30 days.

  7. Time to Ambulation

    Time frame: Time from surgery to first ambulation, assessed during postoperative hospital stay up to 30 days

  8. Length of Hospital Stay

    Time frame: Length of hospital stay from surgery to discharge, assessed up to 30 days.

  9. Incidence of complications

    Time frame: From surgery start until 24 months postoperatively.

    e.g., nerve injury, infection, screw loosening

  10. Radiographic fusion rate

    Time frame: 12 months postoperative

    Evaluated by CT (Bridwell classification)

Study contacts

Contact information is provided by the study sponsor or research team.

You Lv

CONTACT

[email protected]

+86 18861301627

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Lianyungang

Other

Registry information

Official study title

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

Acronym: TLIF

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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