Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

Degenerative Spondylolisthesis Clinical Trial

Official title:

Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03856554
• Other study ID #: KNUH 2017-04-021-004
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: February 2019
• Source: Kyungpook National University
• Contact: Woo-Kie Min, MD, PhD
• Phone: +82 53 420 5628
• Email: oswkmin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• lumbar degenerative spondylolisthesis

• indicated for surgery

Exclusion Criteria:

• not agreed for the study

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis
• Spondylolisthesis
• Transforaminal Lumbar Interbody Fusion

Intervention

Procedure:
• Unilateral Transforaminal Interbody fusion
TLIF via unilateral factectomy and insertion of one cage
• Bilateral Transforaminal Interbody fusion
TLIF via bilateral factectomy and insertion of two cages

Locations

Country	Name	City	State
Korea, Republic of	Spine Center, Kyoungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sagittal balance	Radiologic parameters	through study completion, an average of 1 year
Primary	Interbody fusion(union) failure	Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment	through study completion, an average of 1 year
Secondary	Pain scores	Visual analog scale	through study completion, an average of 1 year
Secondary	Functional scores	36-Item Short Form Survey (SF-36) Scoring	through study completion, an average of 1 year