Actively Recruiting
Clinical Study on the Therapeutic Efficacy of Biportal Endoscopic Decompression Spine Surgery and Lumbar Decompression Fusion Surgery in the Treatment of Degenerative Lumbar Spondylolisthesis
Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2025-12-17
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the therapeutic effects of two surgical methods for treating degenerative lumbar spondylolisthesis, a condition causing chronic back pain and nerve issues. The study compares dual-channel endoscopic spinal decompression with lumbar decompression combined with fusion, aiming to measure differences in pain relief, neurological improvement, and surgical complication rates. This prospective cohort study involves patients selecting their preferred surgery after being informed about both options. Patients undergo thorough preoperative assessments including pain and neurological function evaluations using tools like the Visual Analogue Scale (VAS), JOA score, and ODI score, along with MRI and CT imaging. Surgical details such as operative images, duration, blood loss, and complications are recorded. Tissue samples are collected during surgery for detailed laboratory analysis. Postoperative follow-ups occur at 1, 3, 6, 12, 24, and 36 months to monitor recovery, repeat evaluations, imaging reviews, and complication documentation. Participants provide baseline symptom data and undergo regular evaluations throughout the study period, which lasts up to 36 months after surgery. Researchers analyze collected data statistically to compare the two surgical techniques on pain, neurological function, and imaging results. The study aims to provide detailed insight into the efficacy and safety of these treatments for lumbar degenerative spondylolisthesis.
CONDITIONS
Brief Title
Clinical Study on the Therapeutic Efficacy of Biportal Endoscopic Decompression Spine Surgery and Lumbar Decompression Fusion Surgery in the Treatment of Degenerative Lumbar Spondylolisthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 such as MRI or CT
- No significant improvement after at least 3 months of conservative treatment like medication or physical therapy, meeting surgical indications
- Understand and consent to the study procedures and sign the informed consent form
You will not qualify if you...
- Acute spinal cord compression symptoms or need for urgent surgical intervention
- History of spinal surgery or spinal deformities, severe osteoporosis, or active infections that may affect surgery
- Severe health problems such as cardiovascular disease, liver or kidney failure, or uncontrolled diabetes
- Psychiatric disorders or cognitive impairments that prevent understanding or cooperation with the study
- Allergies to anesthetics or surgical equipment that increase surgical risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 1 week
Participants undergo detailed pain and neurological function evaluations and imaging scans before surgery.
1 to 2 visits (in-person) for assessments and imaging
Duration - Day of surgery
Participants receive either biportal endoscopic decompression spine surgery or lumbar decompression fusion surgery as per their choice.
1 surgical visit (in-person)
Duration - 36 months
Participants are followed for recovery, with repeated pain, neurological, and imaging assessments to monitor outcomes and complications.
6 visits at 1, 3, 6, 12, 24, and 36 months post-surgery (in-person)
Trial Site Locations
Total: 1 location
1
4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, China, 322000
Actively Recruiting
Research Team
X
xiang xue, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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