Clinical Study on the Therapeutic Efficacy of Biportal Endoscopic Decompression Spine Surgery and Lumbar Decompression Fusion Surgery in the Treatment of Degenerative Lumbar Spondylolisthesis

NCT07289737 | Recruiting

• 1 other identifier: KY-2025-093
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to systematically evaluate the therapeutic efficacy of dual-channel endoscopic spinal decompression versus lumbar decompression with fusion for degenerative lumbar spondylolisthesis. Patients undergoing either procedure will undergo detailed preoperative and postoperative follow-up to compare outcomes between the two techniques, specifically assessing postoperative pain relief, neurological improvement, and the incidence of surgical complications.

Conditions

Lumbar Degenerative Spondylolisthesis

Keywords

lumbar; ube; Lumbar Degenerative Spondylolisthesis

Outcome Measures

Primary Outcomes (3)

• VAS

  Pain Score

  36 month

• JOA score

  Function Score

  36month

• ODI

  Function Score

  36month

Study Arms (2)

UBE

Only decompression

Fusion

Lumbar Spine Fusion Surgery

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lumbar degenerative spondylolisthesis

You may qualify if:

• Aged between 50 and 90 years old with a confirmed diagnosis of degenerative lumbar spondylolisthesis;
• Clinical symptoms include chronic pain, nerve compression, or motor dysfunction, confirmed by imaging studies (e.g., MRI or CT);
• No significant improvement after at least 3 months of conservative treatment (e.g., medication, physical therapy), meeting surgical indications;
• Understand and consent to the relevant procedures of this study, and sign the informed consent form.

You may not qualify if:

• Patients exhibiting acute spinal cord compression symptoms or requiring urgent surgical intervention;
• Patients with a history of spinal surgery or conditions such as spinal deformities, severe osteoporosis, or active infections that may compromise surgical outcomes;
• Patients with severe comorbidities affecting assessment, such as cardiovascular disease, liver or kidney failure, or uncontrolled diabetes;
• Patients with psychiatric disorders or cognitive impairments preventing understanding or cooperation with the study process;
• Patients with allergies to anesthetics or surgical equipment that may increase intraoperative risks.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

4th Affiliated Hospital, School of Medicine, Zhejiang University

Yiwu, Zhejiang, 322000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Intraoperative resection of the ligamentum flavum, intervertebral disc, and bone tissue

Central Study Contacts

xiang xue, MD

CONTACT

+86 057989935990; xuexiang@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)