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LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis | Clinical Trials | Clareo Health

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LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

A Randomized, Controlled Trial of Lateral Lumbar Interbody Fusion Plus Posterior Decompression or Not for Severe Lumbar Spinal Stenosis

NCT04094220•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. However, whether additional posterior decompression is necessary for these patients is unknown. Radiographic predictors of failed indirect decompression via LLIF is unknown. In current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received LLIF plus posterior decompression and those without posterior decompression.

Detailed Description

The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. Patients will be followed for one year. Clinical outcomes of the two groups will be compared. And radiographic predictors of failed indirect decompression via LLIF will be analyzed.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients who are 50 - 80 years of age.
•Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at one or two contiguous lumbar levels between L1 and L5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain.
•Patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment.
•Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.

Exclusion Criteria

•Patients with lumbar pathologies requiring treatment at more than two levels.
•Patients who have had previous lumbar fusion surgery.
•Patients with congenital lumbar stenosis.
•Patients with radiographic confirmation of Grade IV facet joint disease or degeneration.
•Patients with noncontained or extruded herniated nucleus pulposus.
•Patients with active local or systemic infection.
•Patients with rheumatoid arthritis or other autoimmune disease.
•Patients who cannot undergo magnetic resonance imaging (MRI).
•Patients who are mentally incompetent.
•Patients with BMI over 30kg/m2 or less than 18 kg/m2.

Locations (1)

The Second Affiliated Hospital of Medical College Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

August 1, 2019

Primary Completion Date

December 30, 2022

Completion Date

December 30, 2022

Last Updated

December 29, 2023

Enrollment

ACTUAL participants

Conditions

Lumbar Spine DegenerationLumbar Spinal Stenosis

Interventions

Lateral lumbar interbody fusion

PROCEDURE

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RECRUITINGPHASE4

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

Inclusion Criteria

Exclusion Criteria

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Home-based Cycling for People With Lumbar Spinal Stenosis

OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults

Prediction of TEI Success in Sciatica

Balance Amongst Patients With Lumbar Spinal Stenosis