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Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

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ClinicalTrials.gov Identifier: NCT03856554
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Woo-Kie Min, Kyungpook National University

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

Condition or disease Intervention/treatment Phase
Degenerative Spondylolisthesis Transforaminal Lumbar Interbody Fusion Procedure: Unilateral Transforaminal Interbody fusion Procedure: Bilateral Transforaminal Interbody fusion Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Transforminal lumbar interbody fusion

: unilateral versus bilateral facetectomy

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2020

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




Primary Outcome Measures :
  1. Sagittal balance [ Time Frame: through study completion, an average of 1 year ]
    Radiologic parameters

  2. 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


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: through study completion, an average of 1 year ]
    Visual analog scale

  2. Functional scores [ Time Frame: through study completion, an average of 1 year ]
    36-Item Short Form Survey (SF-36) Scoring



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lumbar degenerative spondylolisthesis
  • indicated for surgery

Exclusion Criteria:

  • not agreed for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856554


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

Locations
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Korea, Republic of
Spine Center, Kyoungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Woo-Kie Min, MD, PhD         
Sponsors and Collaborators
Kyungpook National University

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Responsible Party: Woo-Kie Min, Associate Professor, Spine Center and Department of Orthopedic Surgery, Kyungpook National University
ClinicalTrials.gov Identifier: NCT03856554     History of Changes
Other Study ID Numbers: KNUH 2017-04-021-004
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases