Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- mechanical axis
研究概览
简要总结
Through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. Prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to TKA were explored, providing references for clinical diagnosis and follow-up research.
详细描述
Through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA We summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. primary knee osteoarthritis;
- •b. Unilateral primary knee replacement;
- •c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide
排除标准
- •a. A history of renal insufficiency (Cr > 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy;
- •b. Those who do not accept this test for any reason and refuse to sign the informed consent.
结局指标
主要结局
mechanical axis
时间窗: Postoperative day 3
The postoperative HKA Angle was measured, that is, the Angle between the center of the hip joint and the center of the knee joint and the center of the knee joint and the center of the ankle joint on the full-length X-ray film of the lower limb. The target Angle was defined as 0°, the Angle was positive when the knee was varus, the Angle was negative when the knee was varus, and the acceptable range was ±3°, beyond which the line deviation was defined.
次要结局
- operation time(immediately after the surgery)
- Postoperative complication(3 years postoperatively)
- Intraoperative blood loss(immediately after the surgery)
- Intraoperative complications(immediately after the surgery)
- Total postoperative blood loss(Postoperative day 3)
- Western Ontario and McMaster Universities Osteoarthritis Index(36 months postoperatively)
- Blood transfusion rate(At discharge)
- Rotation Angle of femur prosthesis(Postoperative day 3)
- Visual analogue scale(36 months postoperatively)
- Range of motion(36 months postoperatively)
- knee society score(36 months postoperatively)
- Patient satisfaction(36 months postoperatively)
- Length of stay(an average of 3 days postoperatively)
- Medical expenses(an average of 3 days postoperatively)
研究者
Tian Hua
archiater
Peking University Third Hospital