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

NCT06506500 | Completed

• 1 other identifier: SYSKY-2024-365-01
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Degenerative Disease

Outcome Measures

Primary Outcomes (1)

• ODI

  Oswestry Disability Index

  before surgery，1-week，1-month，3-month，6-month and 1-year postoperative

Study Arms (2)

ULIF

Unilateral Biportal Endoscopy Lumbar Interbody Fusion

PLIF

Posterior Lumbar Interbody Fusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University,

Guangzhou, Guangdong, 512000, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: November 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: May 1, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

CN (1)