A Controlled Study of Articular Process Retractor Assisted- Multifidus Lateral Approach for Transforaminal Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the degree of paraspinal muscle degeneration
研究概览
简要总结
In recent years, hand-held retractors have been applied to assist in Wiltse approach to perform canal decompression, causing less paraspinal muscle injury and yielding better postoperative clinical outcomes than P-TLIF. However, few prospective studies have been conducted comparing the clinical and radiological outcomes between Wiltse TLIF and P-TLIF, both assisted by hand-held retractors. Therefore, further research is warranted to assess whether hand-held retractor-assisted Wiltse TLIF can yield less paraspinal muscle injury and better postoperative clinical outcomes.
详细描述
Study procedures How many people will participate in this study? Approximately 60 people will participate in this study conducted at the Nanfang Hospital of Southern Medical University.
Research Steps ■ Pre-study:
To determine if you are eligible to participate, the following procedures will be conducted during the screening:
Obtain your demographic and vital sign information Perform a physical examination Inquire about your medical history and concurrent medications Collect blood and urine samples for laboratory testing, imaging (X-ray, CT, MRI) If you are a fertile female, a pregnancy test will be conducted. A negative result is required for your participation in this study.
The screening results and/or results of relevant issues will help the researchers decide if you can continue with this study. If these checks indicate that you are suitable for this study, you will be informed by the researchers to proceed to visit 2 as soon as possible. If you do not meet the relevant criteria, you cannot continue to participate in this study, and the results will be communicated to you promptly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients underwent either one or two-level spinal fusion surgery due to lumbar stenosis, grade 1 or 2 spondylolisthesis, or lumbar disc herniation with lumbar instability and mechanical lower back pain
排除标准
- •Patients with lumbar infection (i), spinal tumor (ii), severe osteoporosis (iii), pregnant and lactating women (iv), severe lumbar stenosis (v), and severe comorbidities (vi)
结局指标
主要结局
the degree of paraspinal muscle degeneration
时间窗: 6 months postoperatively
the infiltration of fat and connective tissue are mainly manifested as enhanced signals on T2-weighted imaging
次要结局
- the degree of paraspinal muscle degeneration(Preoperative,7 days, 3, 6, and 12 months after surgery)