Digital Preop-planning of Total Hip Arthroplasties in Orthopedic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- postoperative residual discrepancy
研究概览
简要总结
Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes
详细描述
Total hip arthroplasties (THAs) are used to restore locomotion. More than 150,000 THAs are performed each year in France. Better outcomes require a restoration of limb lengths and anatomy. Post-operative discrepancy is the main cause of complaints and financial compensation in the US after THA. As such, the investigators aim to use preoperative digital planning using TraumaCad to optimize the restoration of the center of rotation of the hips. Preoperative planning are usually performed using anteroposterior standard radiographs, which are scaled to an inaccurate scale. The TraumaCad system (Brainlab®) allows the adjustment of the scales to each patient and the virtual positioning of the implants in order to simulate the intervention for the restitution of the geometrical parameters of the hip.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •being older than18 years,
- •osteoarthritis as the indication for THA
排除标准
- •THAs after femoral neck fractures,
- •revision surgery,
- •major architectural anomaly (Bone tumor, prior fracture of the pelvis, hip dysplasia),
- •patients under legal protection,
- •pregnancy or breast-feeding
结局指标
主要结局
postoperative residual discrepancy
时间窗: day 3
The primary endpoint is the postoperative residual discrepancy measured on the radiographs on postop day 3 in millimeter compared using standard planning methods compared to TraumaCad.
次要结局
- comparison of pelvis parameters(day 3)
- comparisons of the reproducibility of the femoral implants sizes(day 3)