LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

NCT04094220 | Completed DMC

• 1 other identifier: 2019-161
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Degeneration; Lumbar Spinal Stenosis

Keywords

indirect decompression; lateral interbody fusion; lumbar; direct decompression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analogue Scale (VAS)

  Preoperative, 3-month, 12-month,24-month after surgery

• Zurich Claudication Questionnaire(ZCQ)

  Preoperative, 3-month, 12-month,24-month after surgery

Other Outcomes (5)

• Axial central canal area

  Preoperative,postoperative,12-month,24-month after surgery

• Midsagittal canal diameter

  Preoperative,postoperative,12-month,24-month after surgery

• anterior and posterior disc height

  Preoperative,postoperative, 6-month,12-month,24-month after surgery

Study Arms (2)

Lateral lumbar interbody fusion

EXPERIMENTAL

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

Lateral lumbar interbody fusion plus posterior decompression

EXPERIMENTAL

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

Procedure: Lateral lumbar interbody fusion

Interventions

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.

Lateral lumbar interbody fusion; Lateral lumbar interbody fusion plus posterior decompression

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Medical College Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Fangcai Li, MD

  The Second Affiliated Hospital of Medical College Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 18, 2019
• Study Start: August 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 29, 2023

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)