Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

NCT ID: NCT03856554

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2020-05-31

Brief Summary

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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

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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"

Conditions

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Degenerative Spondylolisthesis Transforaminal Lumbar Interbody Fusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Transforminal lumbar interbody fusion

: unilateral versus bilateral facetectomy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients indicated for TLIF

Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery

Group Type EXPERIMENTAL

Unilateral Transforaminal Interbody fusion

Intervention Type PROCEDURE

TLIF via unilateral factectomy and insertion of one cage

Bilateral Transforaminal Interbody fusion

Intervention Type PROCEDURE

TLIF via bilateral factectomy and insertion of two cages

Interventions

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Unilateral Transforaminal Interbody fusion

TLIF via unilateral factectomy and insertion of one cage

Intervention Type PROCEDURE

Bilateral Transforaminal Interbody fusion

TLIF via bilateral factectomy and insertion of two cages

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* lumbar degenerative spondylolisthesis
* indicated for surgery

Exclusion Criteria

* not agreed for the study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Woo-Kie Min

Associate Professor, Spine Center and Department of Orthopedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spine Center, Kyoungpook National University Hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Woo-Kie Min, MD, PhD

Role: CONTACT

+82 53 420 5628

Facility Contacts

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Woo-Kie Min, MD, PhD

Role: primary

Other Identifiers

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KNUH 2017-04-021-004

Identifier Type: -

Identifier Source: org_study_id

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