NCT03856554

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

March 7, 2018

Last Update Submit

February 25, 2019

Conditions

Degenerative SpondylolisthesisTransforaminal Lumbar Interbody Fusion

Outcome Measures

Primary Outcomes (2)

  • Sagittal balance

    Radiologic parameters

    through study completion, an average of 1 year

  • 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 Outcomes (2)

  • Pain scores

    through study completion, an average of 1 year

  • Functional scores

    through study completion, an average of 1 year

Study Arms (1)

Patients indicated for TLIF

EXPERIMENTAL

Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery

Procedure: Unilateral Transforaminal Interbody fusionProcedure: Bilateral Transforaminal Interbody fusion

Interventions

Unilateral Transforaminal Interbody fusionPROCEDURE

TLIF via unilateral factectomy and insertion of one cage

Patients indicated for TLIF
Bilateral Transforaminal Interbody fusionPROCEDURE

TLIF via bilateral factectomy and insertion of two cages

Patients indicated for TLIF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • lumbar degenerative spondylolisthesis
  • indicated for surgery

You may not qualify if:

  • not agreed for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Center, Kyoungpook National University Hospital

Daegu, South Korea

RECRUITING

Central Study Contacts

Woo-Kie Min, MD, PhD

CONTACT

+82 53 420 5628oswkmin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Transforminal lumbar interbody fusion : unilateral versus bilateral facetectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Spine Center and Department of Orthopedic Surgery

Study Record Dates

First Submitted

March 7, 2018

First Posted

February 27, 2019

Study Start

July 6, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2020

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)