Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Accuracy of placement of a screw or K wire in other bones
研究概览
简要总结
The Investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. The aim of the study is to assess:
Accuracy in vivo Safety Acceptability of use amongst surgeons and theatre staff
详细描述
This project is a collaboration between the Royal United Hospitals Bath and the Department of Mechanical Engineering at the University of Bath in the development of a drill guidance system to aid intra-operative surgical drilling in Orthopaedic and trauma surgery. The types of operation will include drilling into bones to place screws or wires to develop a track for passage of a screw, suture or other material. The project has been funded by an National Institute for Health Invention for Innovation Grant (NIHR i4i) over 3 years.
The Drill Guide System (DGS) has been developed so it can be attached to a surgical drill with the overall aim of improving the accuracy of surgical drilling of holes in bones. The drilling will be performed as standard, i.e. as required for any specific operation. The drill guide will be an adjunct to visual observation by the surgeon and fluoroscopy (peri-operative radiographs - X-rays). The surgeon can decide to not use the drill guide if it is considered to be hampering the operation. A camera and computer based system attached to a surgical drill will be used to improve drilling accuracy in an operating theatre
The Drill Guidance system has undergone rigorous testing and various laboratory trials with surgeons and operating staff as part of development of the design.
The final prototype will be used as part of a wider clinical trial involving Orthopaedic Surgeons at the Royal United Hospitals Bath and the Great Western Hospital, Swindon (within the NHS) to test the efficacy and value of the system during surgery.
The Investigators intend to recruit up to 30 surgical patients as part of the trial from two sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •adults, i.e. 18 years or over;
- •awaiting orthopaedic or trauma surgery;
- •have capacity to consent to participate in the study
- •the proposed operation is deemed to be appropriate by the treating Orthopaedic surgeon for use of the DGS
排除标准
- •children, i.e. < 18 years of age
- •the patient is unable to give informed consent;
- •the surgeon does not feel able to use the DGS
- •the surgeon does not feel use of the DGS is appropriate for the type of surgery required
结局指标
主要结局
Accuracy of placement of a screw or K wire in other bones
时间窗: 3 months
Other fractures: at the point the surgeon plans to drill for the material screw/wire they will declare the planned exit point of the screw/wire using x and y co-ordinates in mm relative to a defined bony landmark prior to the use of the Drill Guide System. The screw/wire position on post-operative CT scans will be defined by the position of the tip of the screw/wire (or its projection to the outer cortex of the bone if it does not reach). This will be compared to the planned exit point to give distance and vector measurements Measurements will be made with the computer measuring system on the Patient Archiving Communication System
Accuracy of placement of a screw or K wire in scaphoid bones
时间窗: 3 months
1.Scaphoid fractures: "best practice" is screw placement in the central third of the scaphoid. This has been defined using CT scans in the Scaphoid Waist Internal Fixation for Fractures (SWIFFT) trial. When fixing a scaphoid fracture the surgeon will aim to place the screw in the central third of the scaphoid (standard) unless otherwise recorded. The screw position will be measured as central or off-centre (as in SWIFFT trial). The data from the SWIFFT trial will be used as a benchmark Measurements will be made with the computer measuring system on the Patient Archiving Communication System
次要结局
- Length of material part of the procedure(Duration of the operation)
- Initial acceptability to surgeons and theatre staff(3 months, i.e. duration of the study)
- Number of fluoroscopy (perioperative X-ray) images performed(Duration of the operation)
- Overall acceptability to surgeons and theatre staff(3 months)
- Number of patients with treatment related adverse events as assessed by CTCAE v4.0(WIthin 3 months of surgery (the planned follow-up period))
- Immediate acceptability to surgeons and theatre staff(3 months, i.e. duration of the study)