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Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion

Sponsor
Tang-Du Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04778943
Collaborator
(none)
130
Enrollment
29
Anticipated Duration (Days)

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Surgery(OLIF and MIS-TLIF)

Study Design

Study Type:
Observational
Anticipated Enrollment :
130 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis
Anticipated Study Start Date :
Feb 28, 2021
Anticipated Primary Completion Date :
Mar 25, 2021
Anticipated Study Completion Date :
Mar 29, 2021

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Oswestry Disability Index (ODI), , and Short Form-36 (SF-36) scores; discal and foraminal height; lumbar lordotic angle; and fusion status. [2 Years]

    Before surgery and at the last follow-up, the following information was recorded

Secondary Outcome Measures

  1. Japanese Orthopaedic Association (JOA) [2 Years]

    Before surgery and at the last follow-up, the following information was recorded

  2. visual analogue scale (VAS) [2 Years]

    Before surgery and at the last follow-up, the following information was recorded

  3. Short Form-36 (SF-36) scores [2 Years]

    Before surgery and at the last follow-up, the following information was recorded

  4. Major Complication rate [2 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tang-Du Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fei-Long Wei, Clinical Professor, Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT04778943
Other Study ID Numbers:
  • TDGKJZ
First Posted:
Mar 3, 2021
Last Update Posted:
Mar 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fei-Long Wei, Clinical Professor, Tang-Du Hospital
Lumbar spinal stenosis
OLIF
MIS-TLIF
postoperative improvements
Additional relevant MeSH terms:
Spinal Stenosis
Constriction, Pathologic

Study Results

No Results Posted as of Mar 3, 2021