Evaluation of the TruMatch® Personalized Solutions System in Knee Prosthetic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Femorotibial mismatch angle
研究概览
简要总结
Patient specific instrumentation is an alternative to conventional intra- and extra-medullary guides to perform the femoral and tibial cuts in total knee replacement (TKR).
This instrumentation could provide a better alignment of a TKR, reduce blood losses and operative time, and improve clinical outcomes.
The primary goal of this study is to compare the femorotibial mismatch angle of two groups of patients: patients undergoing posterior stabilized, fixed bearing TKR with conventional Attune® instrumentation (DePuy Johnson & Johnson, Warsaw, Indiana), versus patient undergoing TKR with the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) cutting guide.
详细描述
Good alignment after a TKR leads to faster rehabilitation, better clinical outcomes and lower revision rate. A correct rotational (axial) alignment reduces patellofemoral complications, polyethylene wear and unexplained knee pain.
A randomized controlled study is conducted to test if to use the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) patient specific instrumentation reduces the number of patients presenting femorotibial mismatch.
Secondary goals are to compare:
- alignment in the coronal, sagittal and axial plane of the femoral component;
- alignment in the coronal and sagittal plane of the tibial component;
- number of recuts during surgery and surgeon's adherence to planning;
- blood loss;
- clinical outcome after two months using the Oxford Knee Score (OKS).
After having signed informed consent, patients will be randomized in 2 groups preoperatively. A long-leg CT scan, according to manufacturer's instructions, will be performed on patients randomized to the TruMatch® group.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40, <80
- •Indication for TKR
- •Surgical indication for Attune®, posterior stabilized, fixed bearing TKR
- •Patients signed written informed consent
排除标准
- •Age > 80, < 40
- •TKR revision surgery
- •Metal devices within 8 cm from knee articular surfaces
- •Fixed knee deformities greater than 15° in varus, valgus, flexion or tibial slope.
- •Knee ankylosis
- •Previous tibial osteotomy surgery
- •Informed consent not accepted
- •Serious comorbidity
- •Active infections
- •Pregnant or breastfeeding women
结局指标
主要结局
Femorotibial mismatch angle
时间窗: 2 months after surgery
Angle between the posterior femoral condylar plane and the plane passing trough the posterior end of the tibial keel (measured on axial CT-scan).
次要结局
- Knee function(2 months after surgery)
研究者
Pietro Randelli, MD
Assistant Professor
University of Milan