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LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

Primary Purpose

Lumbar Spine Degeneration, Lumbar Spinal Stenosis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lateral lumbar interbody fusion

About this trial

This is an interventional treatment trial for Lumbar Spine Degeneration focused on measuring indirect decompression, lateral interbody fusion, lumbar, direct decompression

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The Second Affiliated Hospital of Medical College Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lateral lumbar interbody fusion

Lateral lumbar interbody fusion plus posterior decompression

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04094220

First Posted

August 26, 2019

Last Updated

December 6, 2020

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04094220

Brief Title

LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spine Degeneration, Lumbar Spinal Stenosis

Keywords

indirect decompression, lateral interbody fusion, lumbar, direct decompression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients included in this study are with degenerative lumbar stenosis and Schizas's stenosis grades C. Patients who suffered from significant lumbar scoliosis, grade 2 spondylolisthesis, lumbar fracture and prior lumbar surgery are excluded from this study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lateral lumbar interbody fusion

Arm Type

Experimental

Arm Description

Arm Title

Lateral lumbar interbody fusion plus posterior decompression

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Lateral lumbar interbody fusion

Intervention Description

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.

Primary Outcome Measure Information:

Title

Oswestry Disability Index (ODI)

Description

The ODI is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability

Time Frame

Twenty-four months after surgery

Secondary Outcome Measure Information:

Title

Visual Analogue Scale (VAS)

Description

The VAS is a self-report measure of the intensity of pain (score range 0 - 10 ). A higher score indicates greater pain intensity.

Time Frame

Twenty-four months after surgery

Title

Zurich Claudication Questionnaire(ZCQ)

Description

Time Frame

Twenty-four months after surgery

Other Pre-specified Outcome Measures:

Title

Axial central canal area

Description

The area of the spinal central canal with the most stenosis at the level of the intervertebral disc on MRI.

Time Frame

Seven days after surgery

Title

Midsagittal canal diameter

Description

The canal diameter at the midsagittal slice on MRI.

Time Frame

Seven days after surgery

Title

anterior and posterior disc height

Description

The disc height at the anterior and posterior rim of the intervertebral disc on X-ray.

Time Frame

Seven days after surgery

Title

The height of the bilateral intervertebral foramen

Description

The distance of minimum diameter between adjacent pedicles on CT.

Time Frame

Seven days after surgery

Title

Disc angle

Description

The angles of the lines parallel to the upper and lower endplates in the intervertebral space.

Time Frame

Seven days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Li, MD

Phone

86-18258120238

lijun24@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fangcai Li, MD

Organizational Affiliation

The Second Affiliated Hospital of Medical College Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Affiliated Hospital of Medical College Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fangcai Li, MD

Phone

8618258120238

2505004@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Jun Li, MD

lijun24@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

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LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

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