Comparison of the Radiographic Outcomes and Total Blood Loss Between Pinless Navigation and Conventional Method in Minimally Invasive Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Radiographic outcome: coronal femoral-component angle (CFA)
研究概览
简要总结
The purpose of this study is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated total knee arthroplasty (TKA) and traditional TKA.
详细描述
Minimal invasive surgery total knee arthroplasty (MIS-TKA) is an excellent surgical procedure for patients with end-stage knee diseases and can reduce the postoperative complications compared with traditional TKA procedures.
However, MIS-TKA procedures require a long learning curve to avoid malposition of prosthesis. In previous studies have demonstrated that the position of prosthesis and the postoperative mechanical axis are critical factors of outcome. Malposition of prosthesis and deviation more than 3 degrees of mechanical axis will lead to asymmetrical tibia-femoral tracking between prosthesis with the wear of linear, and increase the incidence of prosthesis loosening.
Computer navigation assisted system has been used in TKA procedures for more than one decade and has been proven to improve the accuracy of prosthesis placement and postoperative mechanical alignment. Moreover, navigated TKA avoids the use of intramedullary guide and preserve the medullary cavity of femur, so the risks of bleeding and venous thromboembolism are reduced. However, traditional navigation system requires additional procedure to set reference arrays with pin fixation of femur and tibia. Pin wound complications including bleeding, infection, and iatrogenic fracture were reported. Moreover, traditional navigation system requires conventional TKA approach in which the wound length of the knee will be as long as 15 to 20 cm. Therefore a combination of new navigation system with a MIS technique to perform TKA procedure is required The new pinless navigated system for TKA procedures has been developed, as the navigation tools were fixed in the surgical field without additional pin wounds. This advantage meets the rationale of MIS-TKA to take care of both minimal invasive procedures and accuracy of prosthesis placement. Therefore, the investigators want to investigate the application of this pinless navigation system in MIS-TKA procedures.
Our purpose is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated MIS-TKA and traditional MIS-TKA.
Material and Methods:
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
- Double (Participant, Outcomes Assessor)
盲法说明
This study proposed 1:1 randomization into pinless navigation and conventional technique. Each patient who enrolled in this study will be given sequence study number, and the chief surgeon will draw lots to decide which group will be assigned in. The patient and the independent reviewer are kept blinded
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis of the knee secondary to degeneration, inflammatory arthritis, gouty arthritis, posttraumatic arthritis, and undergoing primary unilateral minimally invasive TKA
- •Age > 50 years and < 90 years
- •Failure of medical treatment or rehabilitation.
- •Hemoglobin > 11g/dl,
- •No use of non-steroid anti-inflammatory agent one week before operation
排除标准
- •Preoperative Hemoglobin <11 g/dl
- •History of infection or intraarticular fracture of the affective knee
- •Renal function deficiency (GFR <30 ml/min/1.73m2)
- •Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
- •History of deep vein thrombosis, ischemic heart disease, cardiac arrythmia requiring life-long anti-coagulants, or stroke
- •Contraindications of tranexamic acid, rivaroxaban, or the excipients
- •Allergy to tranexamic acid, rivaroxaban, or the excipients
- •Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
- •Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria
结局指标
主要结局
Radiographic outcome: coronal femoral-component angle (CFA)
时间窗: Three months after operation
Tthe angle between the femoral mechanical axis and the femoral component
Radiographic outcome: coronal tibia-component angle (CTA)
时间窗: Three months after operation
The angle between the tibial shaft axis and the tibial component
Radiographic outcome: anatomic alignment (AA)
时间窗: Three months after operation
The anatomic alignment (AA): an angle between the axis of the femoral shaft and the tibial shaft axis
Radiographic outcome: femoral bowing angle (FBA)
时间窗: Three months after operation
The femoral bowing angle (FBA): the angle between the distal and proximal femoral anatomical axes
Radiographic outcome: the mechanical alignment (MA)
时间窗: Three months after operation
The mechanical alignment (MA): an angle between the mechanical axis of the femur and the tibial shaft axis
次要结局
- Operating Time(After the procedure is done)
- Blood transfusion rate(Three months after operation)
- Total Blood Loss(Postoperative Day 3)
- Venous thromboembolism(Postoperative Day 4)
- Wound complications(Three months after operation)
- Surgical wound length(After the procedure is done)