Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change of the radiological outcomes
研究概览
简要总结
This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.
详细描述
Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;
- •Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;
- •The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.
排除标准
- •Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;
- •Patients with traumatic arthritis and inflammatory arthritis;
- •Patients with huge bone defects around the knee
- •Patients who had active infection around the knee;
- •Patients with knee valgus deformity;
- •Patients with severe extra-articular deformity;
- •Patients who had previous knee surgery;
- •Patients who had periarticular soft tissue dysfunction and neuropathy;
- •Patients who had poor physical condition and could not withstand the operation;
- •Patients who refused to be followed.
结局指标
主要结局
Change of the radiological outcomes
时间窗: Postoperative 12 months
The radiological outcomes include the hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA) of the patients. The data were collected to evaluate the accuracy of the 3DP-designed PSI.
次要结局
- Hospital for Special Surgery knee score (HSS)(Postoperative 1,6,12 months)
- American Knee Society knee score (AKS)(Postoperative 1,6,12 months)
研究者
Xiaojun Duan
Deputy Director of the Center for Joint Surgery
Southwest Hospital, China