Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted total knee arthroplasty | Experimental | Using an orthopedic joint surgery navigation system to assist total knee replacement |
|
| Conventional total knee arthroplasty | Active Comparator | Using a conventional 4-in-1 osteotomy guide for total knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted surgery | Procedure | Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative patient satisfaction | Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery | Month 1, Month 3, Month 6, Month 12, Month 24 |
| Forgotten Joint Scores | 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. | Month 1, Month 3, Month 6, Month 12, Month 24 |
| WOMAC score | 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. | Month 1, Month 3, Month 6, Month 12, Month 24 |
| Knee Society Score | 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. | Month 1, Month 3, Month 6, Month 12, Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| SF-12 | The health status of patients was assessed using the SF-12 health-related quality of life scale. The higher the score, the better the quality of life. | Month 1, Month 3, Month 6, Month 12, Month 24 |
| visual analogue scale score |
| Measure | Description | Time Frame |
|---|---|---|
| mLDFA | the lateral angle between the mechanical axis of the femur and the tangent of the distal end of the femoral prosthesis. The target value is 90°. >90° is varus, and <90° is valgus. Varus or valgus exceeding 3° is defined as femoral prosthesis position deviation. | preoperative Day 1-3, postoperative Day 1-3 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianzuo Zhang, Ph.D | Contact | +8618556533086 | zhangxianzuo@foxmail.com | |
| Xianyue Shen, M.D | Contact | 17843122928 | shenxianyue0616@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Zhu, M.D | The First Affiliated Hospital of USTC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of USTC | Recruiting | Hefei | Anhui | 230001 | China |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
Not provided
Not provided
Not provided
Not provided
Not provided
Outcome assessors are independent of the intervention.
| Conventional total knee arthroplasty | Procedure | Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide |
|
Visual analogue scale (VAS) for pain assessment。0 means no pain, 10 means the most painful, the higher the value, the higher the pain level of the patient
| Month 1, Month 3, Month 6, Month 12, Month 24 |
| Range of motion | Physical examination to assess the knee's range of motion | Month 1, Month 3, Month 6, Month 12, Month 24 |
| Hip-knee-ankle angle | Measuring Hip-knee-ankle angle in radiology | postoperative Day 1-3 |
| Complication | Record the patient's postoperative complications. For example, Persistent pain, fracture, superficial local infection, infection, thromboembolism. | Month 1, Month 3, Month 6, Month 12, Month 24 |
| mMPTA |
medial angle between the mechanical axis of the tibia and the tangent of the tibial prosthesis, the target value is 90°, <90° is varus, >90° is valgus, and valgus exceeding 3° is defined as tibial prosthesis position deviation |
| preoperative Day 1-3, postoperative Day 1-3 |
| Femoral prosthesis flexion angle (α angle) | on the standard lateral knee X-ray, the angle between the anatomical axis of the distal femur and the vertical line of the distal femoral prosthesis | preoperative Day 1-3, postoperative Day 1-3 |
| Tibial posterior tilt angle (β angle): | on the standard lateral knee X-ray, the angle between the anatomical axis of the tibia and the lower surface of the tibial prosthesis. | preoperative Day 1-3, postoperative Day 1-3 |
| D012216 |
| Rheumatic Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |