Single-plane Versus Real-time Biplane Approaches for Ultrasound-Guided Hip Joint Injection: A Prospective Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The first-attempt success rate
研究概览
简要总结
The goal of this clinical trial is to compare the safety and accuracy of single-plane and real-time biplane ultrasound imaging in guiding hip joint injections and explore the application effects of imaging technology in hip joint injections.
详细描述
Real-time biplane imaging, an emerging ultrasound technology, uses a three-dimensional (3D) matrix transducer to display simultaneously he longitudinal and transverse intersecting planes on a single screen without requiring rotation of the transducer. The modality displays the puncture path in real-time and exhibits the spatial relationship between the needle tip and the target site, as well as surrounding structures during guided puncture. This technology significantly improves the puncture success rate and reduces complication rates in procedures such as the placement of intrahepatic bile duct drains and central venous catheters. However, this technology has not yet been implemented for hip joint injections. Therefore, we compared the safety and accuracy of single-plane and real-time biplane ultrasound imaging in guiding hip joint injections and explored the application effects of imaging technology in hip joint injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
There are practical differences in operation and blind methods cannot be achieved.
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.15 to 80 years of age; 2.hip joint pain and/or limited hip joint mobility; 3.physical examination and imaging studies indicating hip joint pathology; 4.pain duration exceeding 6 months with no significant improvement after conservative treatment; 5.patients scheduled for hip arthroscopy.
排除标准
- •a history of hip joint surgery;
- •the presence of lumbar disease, ankylosing spondylitis, or sacroiliac-joint pathology;
- •femoral head necrosis;
- •drug allergies;
- •inability to cooperate, or other contraindications to puncture.
研究组 & 干预措施
The real-time biplane ultrasound guidance group
For the real-time biplane ultrasound guidance group, the hip joint injections was performed under the guidance of Xplane ultrasound with a X6-1 volume transducer probe (frequency range 1.0-6.0MHz).
干预措施: Real-time 3D Xplane ultrasound (Device)
The single-plane ultrasound guidance group
For the single-plane ultrasound guidance group, the hip joint injections was performed under the guidance with a C5-1 convex array transducer (frequency range1.0-5.0 MHz)
结局指标
主要结局
The first-attempt success rate
时间窗: during operation
The proportion of successful entries into the anterior synovial recess and completion of medication injection on the first needle insertion, without adjusting needle tip direction
The final success rate
时间窗: during operation
The proportion of successful medication injections completed with no more than two needle insertions
次要结局
- Puncture time(during operation)
- The number of needle adjustments(during operation)
- The operator confidence score(during operation)
- Complications(during operation)
研究者
Yi Mao
clinician
Chinese PLA General Hospital