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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Lumbar Spine Degeneration
• Intervention / Treatment: Procedure: Lateral lumbar interbody fusion

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Li, MD; Phone Number: 86-18258120238; Email: lijun24@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Medical College Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: Lateral lumbar interbody fusion plus posterior decompression; Patients in this group received lateral lumbar interbody fusion plus posterior decompression.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	The VAS is a self-report measure of the intensity of pain (score range 0 - 10 ). A higher score indicates greater pain intensity.	Preoperative, 3-month, 12-month,24-month after surgery
Zurich Claudication Questionnaire(ZCQ)	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.	Preoperative, 3-month, 12-month,24-month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial central canal area	The area of the spinal central canal with the most stenosis at the level of the intervertebral disc on MRI.	Preoperative,postoperative,12-month,24-month after surgery
Midsagittal canal diameter	The canal diameter at the midsagittal slice on MRI.	Preoperative,postoperative,12-month,24-month after surgery
anterior and posterior disc height	The disc height at the anterior and posterior rim of the intervertebral disc on X-ray.	Preoperative,postoperative, 6-month,12-month,24-month after surgery
The height of the bilateral intervertebral foramen	The distance of minimum diameter between adjacent pedicles on CT.	Preoperative,postoperative, 6-month,12-month,24-month after surgery
Disc angle	The angles of the lines parallel to the upper and lower endplates in the intervertebral space.	Preoperative,postoperative, 6-month,12-month,24-month after surgery

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Fangcai Li, MD, The Second Affiliated Hospital of Medical College Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 24, 2023
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: lumbar; indirect decompression; lateral interbody fusion; direct decompression
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 2019-161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No