NCT04094220

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Spine Degeneration
• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2019-09-18
• Last updated: 2023-12-29

Locations

1 site across 1 country: China