Biportal Endoscopic vs. Lumbar Fusion Surgery for Degenerative Lumbar Spondylolisthesis
This study aims to observe and compare the functional and pain outcomes in adults undergoing either biportal endoscopic surgery or lumbar fusion surgery for degenerative lumbar spondylolisthesis.
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: December 10, 2025
Actual date on which the first participant was enrolled.This clinical study aims to compare two different surgical methods for treating degenerative lumbar spondylolisthesis, a condition that causes lower back pain and can affect mobility. The study involves patients who are considering surgery to relieve their symptoms. Participants are given a choice between two surgical techniques: lumbar fusion surgery and biportal endoscopic decompression, which is a less invasive procedure. This research is important as it seeks to determine which approach is more effective and safer, potentially helping future patients with this condition make better-informed surgical choices. Participants in the study first undergo screening to ensure they meet certain criteria. Those who qualify provide informed consent and have their symptoms and pain levels assessed before surgery. Throughout the study, participants are evaluated using pain and neurological function scores and undergo imaging tests like MRI and CT scans. After surgery, patients have regular follow-ups over three years to monitor their recovery and any complications. During surgery, tissue samples are collected for analysis to understand better the biological effects of the procedures. The study carefully documents all steps and uses statistical tools to compare the effectiveness and safety of both surgical methods, focusing on changes in pain and function scores.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 50 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Aged between 50 and 90 years old with a confirmed diagnosis of degenerative lumbar spondylolisthesis; 2. Clinical symptoms include chronic pain, nerve compression, or motor dysfunction, confirmed by imaging studies (e.g., MRI or CT); 3. No significant improvement after at least 3 months of conservative treatment (e.g., medication, physical therapy), meeting surgical indications; 4. Understand and consent to the relevant procedures of this study, and sign the informed consent form. Exclusion Criteria: 1. Patients exhibiting acute spinal cord compression symptoms or requiring urgent surgical intervention; 2. Patients with a history of spinal surgery or conditions such as spinal deformities, severe osteoporosis, or active infections that may compromise surgical outcomes; 3. Patients with severe comorbidities affecting assessment, such as cardiovascular disease, liver or kidney failure, or uncontrolled diabetes; 4. Patients with psychiatric disorders or cognitive impairments preventing understanding or cooperation with the study process; 5. Patients with allergies to anesthetics or surgical equipment that may increase intraoperative risks.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, ChinaOpen 4th Affiliated Hospital, School of Medicine, Zhejiang University in Google Maps