LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

NCT ID: NCT04094220

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-12-30

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.

Conditions

Lumbar Spine Degeneration; Lumbar Spinal Stenosis

Keywords

indirect decompression; lateral interbody fusion; lumbar; direct decompression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lateral lumbar interbody fusion

Intervention Type: PROCEDURE

LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.

Lateral lumbar interbody fusion plus posterior decompression

Patients in this group received lateral lumbar interbody fusion plus posterior decompression.

Group Type: EXPERIMENTAL

Lateral lumbar interbody fusion

Intervention Type: PROCEDURE

LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.

Interventions

Lateral lumbar interbody fusion

LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fangcai Li, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Medical College Zhejiang University

Locations

The Second Affiliated Hospital of Medical College Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2019-161

Identifier Type: -

Identifier Source: org_study_id