Comparing the Efficacy of Indirect Versus Direct Decompression in Patients Undergoing Oblique Lumbar Interbody Fusion (OLIF)

Multicentor Randomized Controlled Trial Comparing the Efficacy of Indirect Versus Direct Decompression in Patients Undergoing Oblique Lumbar Interbody Fusion (OLIF)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011039

Enrollment

Registered

2025-09-16

Start date

2025-07-30

Completion date

Unknown

Last updated

2025-11-10

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

Conditions

None listed

Interventions

Procedure/Surgery : This study is designed to compare the clinical and radiological outcomes of Oblique Lumbar Interbody Fusion (OLIF) alone versus OLIF combined with direct decompression in patient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female patients aged 40 to 79 years. Patients with moderate or greater lumbar spinal stenosis (Schizas grade B or higher) involving a single lumbar segment between L1 and S1, who are candidates for lumbar interbody fusion surgery. Patients who have not responded to at least 3 months of conservative treatment, or who present with progressive neurological symptoms despite conservative treatment. Patients without communication difficulties that would interfere with the conduct and completion of the clinical trial. Patients willing to comply with the treatment and procedures of the study and to visit the hospital for all follow-up evaluations. Patients who have voluntarily signed a written informed consent form after receiving an explanation of the purpose, methods, and potential benefits of the clinical trial.

Exclusion criteria

Exclusion criteria: Patients requiring surgery for two or more lumbar segments. Patients with a history of lumbar fusion surgery. Patients with congenital lumbar spinal stenosis. Patients with radiologically confirmed grade 3 facet joint degeneration (Weishaupt grading system). Patients with sequestrated lumbar disc herniation. Patients with active local or systemic infection. Patients unable to undergo magnetic resonance imaging (MRI). Uncooperative patients or those with mental disorders making continued postoperative treatment difficult. Patients with preoperative lower limb muscle weakness (Manual Muscle Test grade = 3).

Design outcomes

Primary

Measure	Time frame
Oswestry Disability Index	—

Secondary

Measure	Time frame
Visual Analogue Scale;EuroQol 5-Dimensions;Dubousset Functional Test;Self-Paced Walking Test;radiologic finding	—

Countries

Korea, Republic of

Contacts

Public ContactHyoungmin Kim

Seoul National University Hospital

hmkhm@snu.ac.kr+82-2-2072-7607

Outcome results