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A prospective, randomized controlled, non-inferior clinical study: comparison of the efficacy of TLIF in lumbar spinal stenosis under unilateral biportal endoscopic technique and microscope-assisted technique

A prospective, randomized controlled, non-inferior clinical study: comparison of the efficacy of TLIF in lumbar spinal stenosis under unilateral biportal endoscopic technique and microscope-assisted technique

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069333
Enrollment
Unknown
Registered
2023-03-14
Start date
2023-03-14
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative diseases of the lumbar spine

Interventions

Group A:unilateral biportal endoscopic technique transforaminal lumbar interbody fusion
Group B:microscope-assisted transforaminal lumbar interbody fusion

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 30-80 years old; 2. Patients with lower extremity radiation pain (visual analogue score >= 4 points) with or without low back pain and/or neurogenic intermittent claudication, and confirmed by MRI as L3-L4 or L4-L5 or L5-S1 single-segment degenerative strictures; 3. Radiographically confirmed degenerative or isthmus fissure grade I or II slippage in Meyerding grade, or lumbar spine instability observed on kinetic X-ray (slip change = 3mm sagittal plane level is unstable, or angle change >= 15° sagittal plane rotation is unstable); 4. Preoperative symptoms lasting at least three months, with or without conservative treatment; 5. Sign the informed consent form, be able to accurately read or be accompanied by family members to understand the informed consent form and follow-up related questionnaires; 6. Able and agreed to fully comply with clinical protocols and willing to adhere to follow-up schedules and requirements.

Exclusion criteria

Exclusion criteria: 1. Highly degenerative and isthmus bifida spondylolisthesis (grade III. and IV in Meyerding grade); 2. Narrowing or slipping of more than one segment requires surgical decompression or fusion of >= 2 segments; 3. Failure to perform baseline and/or follow-up MRI or X-ray as required; 4. Any segment fusion of the previous lumbar spine; 5. Other spinal diseases (such as spinal infection, ankylosing spondylitis, other inflammatory spondylitis, spinal tumors, spinal trauma); 6. Presence or history of any other neurological disease or vascular disease of the legs that may interfere with the study assessment; 7. Cognitive and psychological disorders (such as Alzheimer's disease, intellectual disability, or substance abuse); 8. Other diseases deemed inappropriate by the surgeon to participate in the study.

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index;

Secondary

MeasureTime frame
visual analogue scale;the MOS item short from health survey;European five-dimensional health scale;Radiological measurements;

Countries

China

Contacts

Public ContactZhang Liangming

The Third Affiliated Hospital of Sun Yat-sen University

zhanglm36@mail.sysu.edu.cn+86 137 5188 2832

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026