The Role of Virtual Reality Simulation in Acquiring Basic Surgical Skills in Total Hip Arthroplasty by Medical Students- a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Medical Students Surgical Skills Differences Between VR and Control Group.
研究概览
简要总结
This prospective randomised clinical trial aims to test if virtual reality (VR) simulation helps acquire basic surgical skills in total hip arthroplasty (THA) by medical students.
The main question[s] it aims to answer are:
- Can VR simulation develop the medical students' basic surgical skills and medical knowledge in THA?
- Will VR simulation become a part of orthopaedic surgical education?
Participants will be randomised into two groups (VR and control).
- They will be asked to watch a very detailed video explaining basic rules and skills in implanting the acetabular cup and femoral stem in THA
- The VR group will perform at least three VR THA sessions concerning cup (inclination) and stem (version) implantation
- Then all participants will be asked to implant a cup and a stem in a predefined inclination and version, respectively, in sawbones
- The mean difference between the predefined and the actual implanted cup inclination and version of the stem will be compared between groups
详细描述
This study is a prospective randomized controlled trial and received approval from the A.U.Th. Institutional Review Board.
Eligible study participants include undergraduate medical students at our university.
Exclusion criteria include a. postgraduate medical students b. prior experience in THA or general surgery.
One week before the planned VR-THA surgery session, all eligible A.U.Th. Medical students will be invited to an information session regarding the study and will be voluntarily enrolled, providing inform consent.
Medical students were explicitly chosen for participation because they are surgically naïve and would most likely benefit from basic skills training in THA.
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)
盲法说明
The personnel that will assess the cup inclination and stem version will not know the group assignment of the participants
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a. undergraduate medical students at Aristotle University of Thessaloniki
排除标准
- •postgraduate medical students
- •prior experience in THA or general surgery.
研究组 & 干预措施
Control Group
This group will include medical students who will only watch instructional videos on basic THA skills on the cup or stem implantation before actual implantation on sawbones
干预措施: VR simulation on basic THA skills (Procedure)
VR Group
This group will include medical students who will watch instructional videos and perform three consecutive VR sessions on basic THA skills on the cup or stem implantation before actual implantation on sawbones
干预措施: VR simulation on basic THA skills (Procedure)
结局指标
主要结局
Medical Students Surgical Skills Differences Between VR and Control Group.
时间窗: 2 Months
The primary outcome will be the mean difference between the asked predefined and the actual implanted cup and stem inclination or version between the Control and VR groups. After completing VR training, all participants were asked to implant the cup at a 60-degree inclination in sawbones and the femoral stem at 20 degrees of anteversion. The cup inclination and stem version were evaluated using goniometers and performed by study personnel unaware of the participant's group assignment. To determine the cup inclination and femoral stem version angles, we utilised a hemipelvis and a femoral sawbone, clamps, an acetabular cup and a femoral rasp with an insertion handle, and a standard goniometer. So, the primary outcome was the mean difference between the asked predefined (60 degrees cup inclination/ 20 degrees stem anteversion) and the actual implanted cup and stem inclination or version by the students on sawbones between the Control and VR groups.
次要结局
- Surgical Skills Differences in Implantation Following VR Training vs. No Training(2 months)
- Time Needed to Perform Each Task(seconds)
研究者
Eustathios Kenanidis
Assistant Professor of Orthopaedic Surgery & Traumatology
Aristotle University Of Thessaloniki