Simulation-based Arthroscopic Surgery Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
研究概览
简要总结
The purpose of this study is to determine whether simulation training improves the performance during arthroscopic surgery ('keyhole' surgery into a joint).
详细描述
This single blinded randomised controlled study of junior orthopaedic trainees aims to assess whether the addition of simulation training improves arthroscopic technical skills performance of junior orthopaedic trainees during knee arthroscopy in the operating theatre compared to their usual clinical training programme. This will be assessed using objective motion analysis parameters recorded from wireless elbow-mounted motion sensors during surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Healthy adults, Male or Female, aged 18 years or above.
- •Enrolled in Health Education Thames Valley/Oxford Deanery Training Programme in junior surgical training posts
排除标准
- •Unwilling or unable to provide informed consent
- •Previously completed higher surgical training programme
研究组 & 干预措施
Simulation training
Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
干预措施: Simulation training (Behavioral)
Non-simulation/Routine training
Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
结局指标
主要结局
Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
时间窗: 3 months
Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.
次要结局
- Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
- Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
- Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
- Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
- Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
- Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
- Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
- Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
- Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
- Motion Analysis Parameters During Simulation(3 months)
- Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre(3 months)
- Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
- Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
- Feasibility of Additional Simulation Training(3 months)