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临床试验/NCT07289737
NCT07289737招募中不适用

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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
VAS

研究概览

简要总结

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.

详细描述

1) Screening and enrollment: This study is a prospective cohort study. Patients were screened based on inclusion and exclusion criteria. They were informed that surgical treatment for degenerative lumbar spondylolisthesis could involve either lumbar fusion surgery or dual-channel endoscopic decompression alone. Specific details of both procedures were explained, allowing patients to independently choose their surgical plan. Informed consent was obtained, and baseline data including symptoms, pain scores, and neurological function scores were collected. 2) Preoperative Assessment: All patients undergo detailed pain and neurological function evaluations prior to surgery. Pain intensity is quantified using the Visual Analogue Scale (VAS), while neurological function is assessed using systems such as the JOA score and ODI score. Imaging evaluations include MRI and CT scans. 3) Data Collection: Prospective data collection was conducted for both dual-channel endoscopic spinal decompression and lumbar decompression with fusion procedures. Surgical protocols were standardized, with documentation of operative images, procedure duration, blood loss, and intraoperative complications. Spinal vertebral and accessory tissue specimens were collected during surgery. 4) Postoperative Follow-up: Patients undergo follow-up at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months postoperatively. Repeat preoperative pain and neurological function assessments, conduct regular imaging reviews, and document postoperative recovery, complication rates, and recurrence. 5) Tissue Analysis: Specimens obtained during surgery undergo histological sectioning, RT-qPCR, or Western Blot testing to analyze differences. 6) Data Analysis: Statistical software analyzes collected data to evaluate changes in pre- and postoperative pain scores, neurological function scores, and imaging outcomes. Significance testing compares the efficacy and safety of the two surgical approaches.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

VAS

时间窗: 36 month

Pain Score

JOA score

时间窗: 36month

Function Score

ODI

时间窗: 36month

Function Score

次要结局

未报告次要终点

研究者

发起方
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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