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NCT Number: NCT04094220

LLIF Plus Posterior Decompression 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.

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Key information

Conditions

Lumbar Spine Degeneration Bone Diseases Lumbar Spinal Stenosis Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Medical College Zhejiang University

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lateral lumbar interbody fusion

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.

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 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 outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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.

  2. Zurich Claudication Questionnaire(ZCQ)

    Time frame: 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.

Other outcomes

  1. Axial central canal area

    Time frame: Preoperative,postoperative,12-month,24-month after surgery

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

  2. Midsagittal canal diameter

    Time frame: Preoperative,postoperative,12-month,24-month after surgery

    The canal diameter at the midsagittal slice on MRI.

  3. anterior and posterior disc height

    Time frame: Preoperative,postoperative, 6-month,12-month,24-month after surgery

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

  4. The height of the bilateral intervertebral foramen

    Time frame: Preoperative,postoperative, 6-month,12-month,24-month after surgery

    The distance of minimum diameter between adjacent pedicles on CT.

  5. Disc angle

    Time frame: Preoperative,postoperative, 6-month,12-month,24-month after surgery

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 18, 2019
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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