Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion

February 28, 2021 updated by: Fei-Long Wei, Tang-Du Hospital

Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis

The investigators will retrospectively study lumbar spinal stenosis patients who underwent OLIF or MIS-TLIF with percutaneous pedicle screw fixation between January 2016 and December 2019.The investigators will measure estimated blood loss, operative time, hospital stay, cost, reoperation, and complication incidence, visual analogue scale (VAS), Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA), and Short Form-36 (SF-36) scores, discal and foraminal height, lumbar lordotic angle, and fusion status.The investigators will conduct to evaluate postoperative improvements, complications, and reoperation rates between patients with lumbar spinal stenosis (LSS) undergoing oblique lateral interbody fusion (OLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

130

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who were diagnosed with LSS and underwent either MIS-TLIF or OLIF surgery between January 2016 and December 2019.

Description

Inclusion Criteria:

  • LSS due to neurogenic claudication; Central stenosis or lateral stenosis who need surgery; Single-level, low-grade (Meyerding grade 1 or 2) isthmic spondylolisthesis or degenerative spondylolisthesis; and imaging findings consistent with the symptoms of LSS.

Exclusion Criteria:

  • trauma, active infection, malignant tumors, spinal deformity, previous lumbar fusion, multi-segment fusion, multi-level, high-grade (Meyerding grade 3 or 4) isthmic spondylolisthesis or degenerative spondylolisthesis.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
oblique lateral interbody fusion (OLIF)
Patients with lumbar spinal stenosis undergoing oblique lateral interbody fusion (OLIF)
Other: Surgery(OLIF and MIS-TLIF)
oblique lateral interbody fusion (OLIF); minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)
minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)
Patients with lumbar spinal stenosis undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)
Other: Surgery(OLIF and MIS-TLIF)
oblique lateral interbody fusion (OLIF); minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI), , and Short Form-36 (SF-36) scores; discal and foraminal height; lumbar lordotic angle; and fusion status.
Time Frame: 2 Years
Before surgery and at the last follow-up, the following information was recorded
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Japanese Orthopaedic Association (JOA)
Time Frame: 2 Years
Before surgery and at the last follow-up, the following information was recorded
2 Years
visual analogue scale (VAS)
Time Frame: 2 Years
Before surgery and at the last follow-up, the following information was recorded
2 Years
Short Form-36 (SF-36) scores
Time Frame: 2 Years
Before surgery and at the last follow-up, the following information was recorded
2 Years
Major Complication rate
Time Frame: 2 Years
2 Years

Collaborators and Investigators

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

Sponsor

Tang-Du 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 (Anticipated)

February 28, 2021

Primary Completion (Anticipated)

March 25, 2021

Study Completion (Anticipated)

March 29, 2021

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 28, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDGKJZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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