Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative patient satisfaction
研究概览
简要总结
The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application.
详细描述
The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application. The main questions it aims to answer are:
Does the Orthopedic Joint Surgery Navigation System improve the accuracy of prosthetic component placement in knee replacement surgery? Is the Orthopedic Joint Surgery Navigation System superior to traditional total knee replacement What medical problems do participants encounter when taking medication ABC? Researchers will compare the Orthopedic Joint Surgery Navigation System with traditional total knee replacement surgery (using a "four-in-one" osteotomy guide) to see if the Orthopedic Joint Surgery Navigation System is superior to traditional total knee replacement in terms of prosthesis three-dimensional position, force alignment, patient satisfaction, functional scores, complications, etc.
Participants will:
End-stage knee osteoarthritis patients receive total knee replacement with the Orthopedic Joint Surgery Navigation System or traditional total knee replacement surgery Visit the clinic for examination and testing every 3 months Record their imaging data, satisfaction, functional scores, complications, etc.
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 (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors are independent of the intervention.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in the trial and sign the informed consent form;
- •Aged 18 to 80 years old (inclusive), regardless of gender;
- •Patients who need total knee replacement surgery;
- •Those who can communicate well with the researchers and comply with the trial requirements.
排除标准
- •Patients who are allergic to the drugs used in this trial or the implant materials;
- •Patients with immature bone development;
- •Patients with active infection;
- •Patients with neuropathy of the knee joint;
- •Patients with poor bone quality that is not conducive to prosthesis fixation;
- •Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
- •Patients with insufficient quadriceps muscle strength;
- •Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
- •Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
- •Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
- •Pregnant or lactating women;
- •Patients with severe epilepsy or mental illness;
- •Patients with alcohol dependence or drug addiction;
- •Patients with severe coagulation disorders;
- •Patients who have participated in or are participating in other clinical trials within one month of enrollment;
- •Patients who are considered by the researchers to be unsuitable for participating in this clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.
研究组 & 干预措施
Robot-assisted total knee arthroplasty
Using an orthopedic joint surgery navigation system to assist total knee replacement
干预措施: Robot-assisted surgery (Procedure)
Conventional total knee arthroplasty
Using a conventional 4-in-1 osteotomy guide for total knee replacement
干预措施: Conventional total knee arthroplasty (Procedure)
结局指标
主要结局
Postoperative patient satisfaction
时间窗: Month 1, Month 3, Month 6, Month 12, Month 24
Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery
Forgotten Joint Scores
时间窗: Month 1, Month 3, Month 6, Month 12, Month 24
The Forgotten Joint Score (FJS) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty.The total score is 100 points. The higher the score, the better the degree of forgetfulness of the artificial joint.
WOMAC score
时间窗: Month 1, Month 3, Month 6, Month 12, Month 24
Use WOMAC scoring scale to assess the condition of the knee joint. The WOMAC score consists of 24 items with a total score of 100. The higher the score, the more severe the limitation of joint function.
Knee Society Score
时间窗: Month 1, Month 3, Month 6, Month 12, Month 24
The KSS score was assessed using the American Knee Society scoring criteria.The full score is 100 points. The higher the score, the better the patient's knee function.
次要结局
- SF-12(Month 1, Month 3, Month 6, Month 12, Month 24)
- visual analogue scale score(Month 1, Month 3, Month 6, Month 12, Month 24)
- Range of motion(Month 1, Month 3, Month 6, Month 12, Month 24)
- Hip-knee-ankle angle(postoperative Day 1-3)
- Complication(Month 1, Month 3, Month 6, Month 12, Month 24)