Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- HKA outliers
研究概览
简要总结
This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.
144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-85 years (including 18 and 85), regardless of gender;
- •Patients scheduled for unilateral primary total knee arthroplasty based on the clinical judgment of the study physician;
- •The subject or their guardian has been informed of the study, agrees to all terms of the trial, signs an informed consent form approved by the ethics committee, and agrees to participate in the trial.
排除标准
- •The side scheduled for surgery has significant hip joint disease, such as substantial bone defects or severe limitations in joint mobility;
- •Patients with active infections around the knee joint or systemic infections;
- •Discontinuity or severe functional loss of the knee extensor mechanism, painless knee joint fusion, Charcot joint, poor surgical tolerance, or other conditions that may adversely affect surgical prognosis;
- •Patients with contraindications for traditional TKA surgery;
- •Pregnant or breastfeeding women;
- •Patients known to have excessive alcohol consumption or substance abuse; Body mass index (BMI) > 35 kg/m²;
- •Patients who have participated in other clinical trials within one month prior to signing the informed consent form;
- •Patients with mental or intellectual disabilities that may affect clinical outcome evaluations;
- •Patients deemed unsuitable for participation in this clinical trial by the investigator.
结局指标
主要结局
HKA outliers
时间窗: 12 weeks post-surgery
the proportion of patients with a deviation of ≤ 3° between the mechanical axis (hip-knee-ankle angle, or HKA angle) measured from a full-length, frontal-view lower limb X-ray
次要结局
- Incidence of adverse events and serious adverse events(Through study completion, an average of 12 weeks)
- FFC angle(12 weeks post-surgery)
- outliers of FFC angle(12 weeks post-surgery)
- FTC angle(12 weeks post-surgery)
- outliers of FTC angle(12 weeks post-surgery)
- LFC angle(12 weeks post-surgery)
- outliers of LFC angle(12 weeks post-surgery)
- LTC angle(12 weeks post-surgery)
- outliers of LTC angle(12 weeks post-surgery)
- Surgical duration(During operation)
- Blood loss(3 days after surgery)
- ROM(12 weeks post-surgery)
- Knee Society Score (KSS)(screening and 12 weeks post-surgery.)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(screening and 12 weeks post-surgery.)
研究者
Tian Hua
MD
Peking University Third Hospital