Clinical trial NCT04094220: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Degeneration
Lumbar Spinal Stenosis
Keywords: indirect decompression
lateral interbody fusion
lumbar
direct decompression
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Preoperative, 3-month, 12-month,24-month after surgery
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Preoperative, 3-month, 12-month,24-month after surgery
measure: Zurich Claudication Questionnaire(ZCQ)
timeFrame: Preoperative, 3-month, 12-month,24-month after surgery
Other outcomes:
measure: Axial central canal area
timeFrame: Preoperative,postoperative,12-month,24-month after surgery
measure: Midsagittal canal diameter
timeFrame: Preoperative,postoperative,12-month,24-month after surgery
measure: anterior and posterior disc height
timeFrame: Preoperative,postoperative, 6-month,12-month,24-month after surgery
measure: The height of the bilateral intervertebral foramen
timeFrame: Preoperative,postoperative, 6-month,12-month,24-month after surgery
measure: Disc angle
timeFrame: Preoperative,postoperative, 6-month,12-month,24-month after surgery
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Medical College Zhejiang University
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital of Medical College Zhejiang University
name: Fangcai Li, MD
role: PRINCIPAL_INVESTIGATOR
References: