Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

Not Applicable

• Conditions: Degenerative Spondylolisthesis; Transforaminal Lumbar Interbody Fusion
• Interventions: Procedure: Unilateral Transforaminal Interbody fusion; Procedure: Bilateral Transforaminal Interbody fusion

• Registration Number: NCT03856554
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

A prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis

Detailed Description

Traditionally many spine surgeons prefer single level TLIF surgery via bilateral facetectomy for increasing union rate. Our hypothesis - "Single level TLIF via unilateral facetectomy is sufficient for achieve successful fusion rate"

Study Timeline

• Study Start: 2017-07-06
• Study First Submitted: 2018-03-07
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-27
• Last Update Posted: 2019-02-27
• Primary Completion: 2019-05-31
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• lumbar degenerative spondylolisthesis
• indicated for surgery

Exclusion Criteria

• not agreed for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients indicated for TLIF	Unilateral Transforaminal Interbody fusion	Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery
Patients indicated for TLIF	Bilateral Transforaminal Interbody fusion	Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery

Primary Outcome Measures

Name	Time	Method
Sagittal balance	through study completion, an average of 1 year	Radiologic parameters
Interbody fusion(union) failure	through study completion, an average of 1 year	Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment

Secondary Outcome Measures

Name	Time	Method
Pain scores	through study completion, an average of 1 year	Visual analog scale
Functional scores	through study completion, an average of 1 year	36-Item Short Form Survey (SF-36) Scoring

Trial Locations

Locations (1)

Spine Center, Kyoungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of