Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion

NCT04778943 | Unknown DMC

• 1 other identifier: TDGKJZ
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosis; OLIF; MIS-TLIF; postoperative improvements

Outcome Measures

Primary Outcomes (1)

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

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

  2 Years

Secondary Outcomes (4)

• Japanese Orthopaedic Association (JOA)

  2 Years

• visual analogue scale (VAS)

  2 Years

• Short Form-36 (SF-36) scores

  2 Years

• Major Complication rate

  2 Years

Study Arms (2)

oblique lateral interbody fusion (OLIF)

Patients with lumbar spinal stenosis undergoing oblique lateral interbody fusion (OLIF)

Other: Surgery(OLIF and 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)

Interventions

Surgery(OLIF and MIS-TLIF) OTHER

oblique lateral interbody fusion (OLIF); minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)

minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF); oblique lateral interbody fusion (OLIF)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 3, 2021
• Study Start: February 28, 2021
• Primary Completion: March 25, 2021
• Study Completion: March 29, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-02