Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
研究概览
简要总结
The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The main question it aims to answer is:
- What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures? Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge.
详细描述
To assess the usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The surgeon and OR-assistant will fill in one survey after performing 3 operations with the ADEPTH sensor and one survey after performing 3 operations with the manual depth gauge.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective plate osteosynthesis procedure (clavicula, humerus, radius, ulna, femur, tibia, fibula, malleoli) (incl. delayed union, nonunion, malunion)
- •Needed surgical instrument net: 2.4 / 2.7 / 3.5-4.0 / 4.5-5.0-6.5
- •Adults (≥ 18 years)
- •Written informed consent by patient
排除标准
- •Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis)
- •Variable angle plates
- •Corrective surgery after previous plate osteosynthesis procedure or hardware removal
结局指标
主要结局
Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
时间窗: Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months.
Used tool: System Usability Survey (SUS)
次要结局
- Duration in seconds of the fixation process per screw during plate osteosynthesis(In both study groups the operation will be recorded. Anticipated study duration is 6 months.)