CClinicalTrials.gg
Status unknownNCT03856554Updated Feb 27, 2019

Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

An interventional study of Unilateral Transforaminal Interbody fusion and Bilateral Transforaminal Interbody fusion in Degenerative Spondylolisthesis and Transforaminal Lumbar Interbody Fusion, sponsored by Kyungpook National University Hospital. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Sex
All
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Study 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

Read the 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"

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Conditions studied

  • Degenerative Spondylolisthesis
  • Transforaminal Lumbar Interbody Fusion

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In context

Spondylolisthesis

237 studies on the registry are indexed under Spondylolisthesis; 47 are open to participants now.

This study's planned enrollment of 52 is below the median of 60 across 149 interventional studies indexed under Spondylolisthesis.

Browse Spondylolisthesis studies →

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 76 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • lumbar degenerative spondylolisthesis
  • indicated for surgery

Exclusion criteria

Exclusion Criteria:

  • not agreed for the study
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Patients indicated for TLIF

    Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery

    Procedure: Unilateral Transforaminal Interbody fusion · Procedure: Bilateral Transforaminal Interbody fusion

Interventions

  • ProcedureUnilateral Transforaminal Interbody fusion

    TLIF via unilateral factectomy and insertion of one cage

  • ProcedureBilateral Transforaminal Interbody fusion

    TLIF via bilateral factectomy and insertion of two cages

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What researchers measure

Primary outcomes

  1. Sagittal balance

    Radiologic parameters

    Time frame: through study completion, an average of 1 year

  2. Interbody fusion(union) failure

    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 outcomes

  1. Pain scores

    Visual analog scale

    Time frame: through study completion, an average of 1 year

  2. Functional scores

    36-Item Short Form Survey (SF-36) Scoring

    Time frame: through study completion, an average of 1 year

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Study locations

1 of 1 sites recruiting
  • Spine Center, Kyoungpook National University Hospital
    Daegu, Korea, Republic of
    • Woo-Kie Min, MD, PhD · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03856554
Lead sponsor
Kyungpook National University Hospital
Responsible party
Woo-Kie Min (Associate Professor, Spine Center and Department of Orthopedic Surgery, Kyungpook National University Hospital) — Principal investigator
First posted
Feb 27, 2019
Start date
Jul 6, 2017
Primary completion
May 31, 2019 (estimated)
Completion
May 31, 2020 (estimated)
Last update
Feb 27, 2019

Study contacts

Woo-Kie Min, MD, PhD
Contact
oswkmin@gmail.com
+82 53 420 5628

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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