Actively Recruiting

Age: 50Years - 90Years
All Genders
ID07289737

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

Age: 50Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Preoperative Assessment

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

Surgery

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)

Post-operative Follow-up

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

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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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