Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

February 25, 2019 updated by: Woo-Kie Min, Kyungpook National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Spine Center, Kyoungpook National University Hospital
        • Contact:
          • Woo-Kie Min, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lumbar degenerative spondylolisthesis
  • indicated for surgery

Exclusion Criteria:

  • not agreed for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients indicated for TLIF
Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery
Procedure: Unilateral Transforaminal Interbody fusion
TLIF via unilateral factectomy and insertion of one cage
Procedure: Bilateral Transforaminal Interbody fusion
TLIF via bilateral factectomy and insertion of two cages

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: through study completion, an average of 1 year
Visual analog scale
through study completion, an average of 1 year
Functional scores
Time Frame: through study completion, an average of 1 year
36-Item Short Form Survey (SF-36) Scoring
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2017

Primary Completion (ANTICIPATED)

May 31, 2019

Study Completion (ANTICIPATED)

May 31, 2020

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

February 25, 2019

First Posted (ACTUAL)

February 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUH 2017-04-021-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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