Prospective Assessment of Surgeon Energy Expenditure Using Hexoskin During Anterior Cruciate Ligament Reconstruction: Influence of Anterolateral Ligament Reconstruction and Meniscal Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ASL Lecce
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total Energy Expenditure
研究概览
简要总结
This prospective observational study evaluates the intraoperative energy expenditure of the surgeon during anterior cruciate ligament reconstruction procedures. Energy expenditure and physiological workload will be measured using a wearable Hexoskin shirt during surgery.
The study will compare surgical procedures involving isolated anterior cruciate ligament reconstruction, anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction, and procedures requiring additional meniscal treatment. The aim is to determine whether anterolateral ligament reconstruction meaningfully increases surgeon workload and whether meniscal procedures are associated with higher intraoperative energy expenditure.
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
- 16 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary anterior cruciate ligament reconstruction
- •Unilateral ACL rupture confirmed by clinical examination and MRI
- •Surgery performed by the participating surgeon wearing the Hexoskin device
- •Ability to provide written informed consent
排除标准
- •Revision ACL reconstruction
- •Multiligament knee reconstruction
- •Bilateral knee surgery
- •Concomitant procedures other than ACL reconstruction, ALL reconstruction, meniscal repair, or partial meniscectomy
- •Incomplete intraoperative Hexoskin recording
- •Conversion or interruption of the planned surgical procedure
结局指标
主要结局
Total Energy Expenditure
时间窗: During surgery, from skin incision to wound closure
Total intraoperative energy expenditure of the operating surgeon measured using the Hexoskin wearable device, expressed in kilocalories.
次要结局
- minute ventilation(During surgery, from skin incision to wound closure.)
- Mean heart rate(During surgery, from skin incision to wound closure.)
- surgical time(during surgery, from skin incision to wound closure)
研究者
Jacopo Conteduca
Principal investigator
ASL Lecce