LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

Not Applicable

Completed

• Conditions: Lumbar Spine Degeneration; Lumbar Spinal Stenosis
• Interventions: Procedure: Lateral lumbar interbody fusion

• Registration Number: NCT04094220
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Status Verified: 2020-12
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-12-24
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral lumbar interbody fusion	Lateral lumbar interbody fusion	Patients in this group received lateral lumbar interbody fusion alone. Patients who suffered residual neurologic symptoms postoperatively will received conservative treatment for at least 3 months.Patients were considered to have unsuccessful indirect decompression if they had less than 20% improvement according to the Oswestry Disability Index (ODI) by 3 months postoperatively.
Lateral lumbar interbody fusion plus posterior decompression	Lateral lumbar interbody fusion	Patients in this group received lateral lumbar interbody fusion plus posterior decompression.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Preoperative, 3-month, 12-month,24-month after surgery	The ODI is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability

Secondary Outcome Measures

Name	Time	Method
Zurich Claudication Questionnaire(ZCQ)	Preoperative, 3-month, 12-month,24-month after surgery	The ZCQ is a disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis.The result is expressed as a percentage of the maximum possible score (22.22% - 100%). The score increases with worsening disability.The The ZCQ consists of three subscales: symptom severity scale, physical function scale and patient's satisfaction with treatment scale.
Visual Analogue Scale (VAS)	Preoperative, 3-month, 12-month,24-month after surgery	The VAS is a self-report measure of the intensity of pain (score range 0 - 10 ). A higher score indicates greater pain intensity.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Medical College Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China