Unilateral Biportal Endoscopy Lumbar Interbody Fusion (ULIF) Versus Posterior Lumbar Interbody Fusion (PLIF) in Management of Single Level Lumbar Degenerative Disease: A Retrospective Study

The study aimed to compare the clinical efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion (ULIF) with posterior lumbar interbody fusion (PLIF) in the treatment of single-level lumbar degenerative diseases.

Study Overview

• Status: Completed
• Conditions: Lumbar Degenerative Disease

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 512000
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Patients who have been diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar spondylolisthesis.
2. The patient has clear indications for surgical treatment.
3. The patient is undergoing their initial single-segment ULIF or PLIF surgery at our hospital.

Description

Inclusion Criteria:

1. Patients who have been diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar spondylolisthesis based on their medical history, physical signs, and imaging exams such as lumbar anteroposterior and lateral radiographs (including hyperextension and hyperflexion positions), lumbar CT, and lumbar MR. (2) The patient has clear indications for surgical treatment: ① Conservative treatment for more than three months has been ineffective or the symptoms have continued to worsen ② The patient's symptoms are severe and interfere with their daily work and life ③ The patient exhibits signs of cauda equina nerve compression (such as numbness in the perineal area, loss of bowel and bladder control, etc.).

(3) The patient is undergoing their initial single-segment ULIF or PLIF surgery at our hospital.

Exclusion Criteria:

1. Patients with lumbar degenerative diseases involving two or more segments
2. Pathological changes caused by other diseases, such as spinal infections, spinal trauma, spinal tumors, neurological diseases, etc.
3. Patients with lumbar spondylolisthesis exceeding Meyerding Grade II or degenerative scoliosis with a Cobb angle greater than 20 degrees
4. History of previous lumbar surgery
5. History of previous tumor disease.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ULIF; Unilateral Biportal Endoscopy Lumbar Interbody Fusion
PLIF; Posterior Lumbar Interbody Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ODI	Oswestry Disability Index	before surgery，1-week，1-month，3-month，6-month and 1-year postoperative

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SYSKY-2024-365-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No