Total Knee Arthroplasty in Varus Deformity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Implant position assessment
研究概览
简要总结
For the first time, a comparative analysis of the limb axis in patients with unilateral knee OA will be conducted compared to the contralateral uninjured side using Multisliced computed tomography (MSCT) and vertical CT (weight-bearing CT). This analysis will identify the pathological and physiological degrees of varus in patients with unilateral gonarthrosis. Indications for mechanical and kinematic limb axis alignment will be substantiated depending on the degree of varus deformity. Aim of the study: To improve the results of total knee arthroplasty in patients with varus deformity by optimizing the degree of varus correction. Objectives: To analyze physiological and pathological varus in patients with unilateral osteoarthritis under physiological loading. To develop an algorithm for applying various types of limb alignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patients over 18 years of age with grade 3-4 knee osteoarthritis (according to Kellgren-Lawrence) and pain score of 5 or higher on a 10-point VAS scale.
- •Varus deformity of the lower limb (HKA angle <177°, or varus >3°)
- •Anesthesia risk according to the ASA scale of no more than III.
- •BMI less than 35 kg/m
- •Patient must be monitored throughout the entire study period (12 months).
- •Patient must be mentally competent and compliant.
- •Patient must provide written informed consent to participate in the study.
排除标准
- •Body mass index > 40 kg/m².
- •Instability of the collateral ligaments of the knee joint requiring the installation of ligamentous systems, presence of primary severe bone defects.
- •Impaired weight-bearing ability of the contralateral limb.
- •Presence of metal implants or foreign bodies in the lower extremities.
- •Previous knee interventions, such as reconstruction of the knee ligament apparatus, or corrective osteotomies of the femur and tibia.
- •Patient refusal to participate in the study.
- •Patient failure to comply with the recommendations of the treating physician or the prescribed regimen.
研究组 & 干预措施
Total Knee Arthroplasty using the active robotic system using the kinematic alignment concept
Total knee arthroplasty in varus
干预措施: Total knee arthroplasty using active robotic surgical system (Procedure)
Total Knee Arthroplasty using the active robotic system using the mechanical alignment concept
Total knee arthroplasty in varus
干预措施: Total knee arthroplasty using active robotic surgical system (Procedure)
结局指标
主要结局
Implant position assessment
时间窗: 2 months postoperatively
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
Implant position assessment
时间窗: 6 months postoperativley
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
Implant position assessment
时间窗: 12 months postoperatively
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
次要结局
- Quality of life and knee function assessment(2,6,12 months postoperatively)
- Quality of life assessment (joint awareness after surgery)(2,6,12 months postoperatively)
- Quality of life assessment (the condition of patients)(2, 6, 12 months postoperatively)
- Pain assessment(2, 6, 12 months postoperatively)
- Quality of life assessment (an individual's activities of daily living)(2, 6, 12 months postoperatively)