Virtual 3D Surgical Planning for Tibial Plateau Fractures: A Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Duration of surgery
研究概览
简要总结
Tibial plateau fractures are often complex fractures and need a good preoperative planning. The investigators think that a 3D virtual planning software will help the surgeons to get a better understanding of the fracture and therefore want to study the value of 3D virtual planning software in the preoperative planning of tibial plateau fractures. The investigators hypothesize that this software will shorten the duration of surgery, decrease the peroperative bloodloss and the number of complications.
Patients with tibial plateau fractures who need surgical treatment will be asked to participate in this study. After participants have given informed consent, they will be randomized between a 'traditional preoperative planning' and a '3D virtual preoperative planning' group. Surgeons will plan their surgery using traditional planning tools (X-rays and CT scan) or traditional planning tools ánd the 3D virtual planning software.
6 weeks, 3 months and 6 months after surgery, participants will be asked to fill in 2 questionnaires about knee pain and knee function. After surgery a CT scan or X-ray will be performed conform standard of care in the hospital.
详细描述
Patients with tibial plateau fractures are traditionally challenging to treat, especially the complex fracture patterns in which anatomic reconstruction of the articular surface can be very demanding. In a previous study, the researchteam showed that surgical decision-making should be guided by recognition of specific fracture characteristics, rather than the 'classic' classification of fractures by Schatzker. Recognition of these specific tibial plateau fracture patterns has been proven reliable and reproducible to guide surgeons plan their approach, reduction techniques and fixation.
Building on our improved understanding of (complex) tibial plateau fracture patterns, and how these specific fracture characteristics guide our surgical management, the next step includes meticulous pre-operative surgical planning to achieve the best functional results for our patients. A new state-of-the-art tool is currently available to aid surgeons in 3D virtual planning of approach, reduction strategy, and even application of hardware (i.e. size of plates and lengths of screws (https://sectra.com/medical/product/sectra-3d-trauma/).
Recent studies on virtual surgical planning for fracture care have shown variable results. One study concluded that there was a significant reduction in duration of surgery in about 75.0% of all cases. Another study showed improvement of the outcomes of acetabular fracture surgery by reduced duration of the surgery and improved quality of the reduction. However, a third study showed that 3D virtual reality is inferior compared to 3D printed models on acetabular fractures in terms of interobserver agreement. In conclusion, the added value of virtual preoperative planning has yet to be determined.
If virtual surgical planning is as promising as some of the previous results show, it could also have a significant impact on the surgical reduction in the treatment of tibial plateau fractures. This might lead to a reduction of duration of surgery, less complications and better patient related outcomes, such as postoperative pain and knee function.
Therefore, the investigators would like to compare the conventional preoperative planning with the preoperative planning with use of the virtual planning software of Sectra AB for tibial plateau fractures in terms of duration of surgery, surgical complications and patient related outcomes.
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
- Double (Participant, 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
- 否
入选标准
- •Adult patients of 18 years or older with a tibial plateau fracture who will receive surgical treatment for this fracture
排除标准
- •patients with (general) bone diseases or osseous malformation syndromes,
- •ipsilateral limb fractures,
- •complicated tibial plateau fractures that need an external fixator,
- •previous tibial plateau fractures
- •previous surgical treatment of the tibial plateau
结局指标
主要结局
Duration of surgery
时间窗: Intraoperative
Time in minutes from start of surgery till end of surgery
次要结局
- Surgical complications(up to 30 days postoperative)
- Postoperative knee pain(Measured at 6 weeks, 3 months and 6 months postoperative)
- Perioperative deviations(Immediately after x-ray or CT scan is performed)
- Postoperative knee function(Measured at 6 weeks, 3 months and 6 months postoperative)
- Blood loss(Intraoperative)
- Quality of reduction(Immediately after x-ray or CT scan is performed)
