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Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

Primary Purpose

Degenerative Spondylolisthesis, Transforaminal Lumbar Interbody Fusion

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Unilateral Transforaminal Interbody fusion
Bilateral Transforaminal Interbody fusion
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spondylolisthesis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lumbar degenerative spondylolisthesis
  • indicated for surgery

Exclusion Criteria:

  • not agreed for the study

Sites / Locations

  • Spine Center, Kyoungpook National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients indicated for TLIF

Arm Description

Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery

Outcomes

Primary Outcome Measures

Sagittal balance
Radiologic parameters
Interbody fusion(union) failure
Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment

Secondary Outcome Measures

Pain scores
Visual analog scale
Functional scores
36-Item Short Form Survey (SF-36) Scoring

Full Information

First Posted
March 7, 2018
Last Updated
February 25, 2019
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03856554
Brief Title
Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis
Official Title
Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spondylolisthesis, Transforaminal Lumbar Interbody Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Transforminal lumbar interbody fusion : unilateral versus bilateral facetectomy
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients indicated for TLIF
Arm Type
Experimental
Arm Description
Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery
Intervention Type
Procedure
Intervention Name(s)
Unilateral Transforaminal Interbody fusion
Intervention Description
TLIF via unilateral factectomy and insertion of one cage
Intervention Type
Procedure
Intervention Name(s)
Bilateral Transforaminal Interbody fusion
Intervention Description
TLIF via bilateral factectomy and insertion of two cages
Primary Outcome Measure Information:
Title
Sagittal balance
Description
Radiologic parameters
Time Frame
through study completion, an average of 1 year
Title
Interbody fusion(union) failure
Description
Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Pain scores
Description
Visual analog scale
Time Frame
through study completion, an average of 1 year
Title
Functional scores
Description
36-Item Short Form Survey (SF-36) Scoring
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lumbar degenerative spondylolisthesis indicated for surgery Exclusion Criteria: not agreed for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Woo-Kie Min, MD, PhD
Phone
+82 53 420 5628
Email
oswkmin@gmail.com
Facility Information:
Facility Name
Spine Center, Kyoungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo-Kie Min, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

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