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Unilateral Biportal Endoscopic Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion in Treating Single-Segment Lumbar Instability and Lumbar Spondylolisthesis (Meyerding Grades I and II): An Open-Label, Randomized Controlled, Non-inferiority Study

Unilateral Biportal Endoscopic Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion in Treating Single-Segment Lumbar Instability and Lumbar Spondylolisthesis (Meyerding Grades I and II): An Open-Label, Randomized Controlled, Non-inferiority Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082852
Enrollment
Unknown
Registered
2024-04-09
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Lumbar Instability and Lumbar Spondylolisthesis

Interventions

Group A:Unilateral Biportal Endoscopy Transforaminal Lumbar Interbody Fusion
Group B:Minimally Invasive Transforaminal Lumbar Interbody Fusion

Sponsors

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

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients eligible for inclusion meet the following criteria: (1) Single-segment degenerative or isthmic lumbar spondylolisthesis (Meyerding Grades I and II): vertebral slippage not exceeding one-half of the vertebral body's sagittal diameter; (2) Single-segment lumbar segmental instability: dynamic X-ray showing sagittal plane displacement of the slipped vertebra =3 mm and/or an increase in segmental sagittal motion (extension or flexion positioning resulting in an intervertebral angle =11°); (3) Presence of lower back pain and/or symptoms of radicular pain, numbness, weakness, or intermittent claudication in the lower extremities; (4) Ineffectiveness of conservative treatment for a duration of 3 months.

Exclusion criteria

Exclusion criteria: Patients with one or more of the following conditions are excluded from the study: (1) Systemic or localized active infection; (2) Malignant tumors: Patients with a confirmed history of malignancy (excluding non-malignant melanoma), unless they have undergone effective treatment and have been free of clinical symptoms and signs for at least 5 years; (3) History of lumbar spine surgery, or presence of other spinal diseases such as ankylosing spondylitis, spinal tumors, spinal fractures, or neurological diseases; (4) Coexisting significant organ pathology or other reasons that preclude the patient from undergoing or tolerating surgery, or an American Society of Anesthesiologists (ASA) classification of IV or higher; (5) Cognitive and psychological disorders and other diseases that make participation in the study inappropriate; (6) Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index;

Secondary

MeasureTime frame
Japanese Orthopaedic Association Scores, JOA;Quebec Back Pain Disability Scale, QBPDS;Visual Analogue Scale, VAS;Radiological measurements;Surgery related conditions;Low back muscle function evaluation;

Countries

China

Contacts

Public ContactQiji Li

The Seventh Affiliated Hospital of Sun Yat-sen University

liqj27@mail.sysu.edu.cn+86 132 4280 2992

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026