Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Robot-assisted surgery; Procedure: Conventional total knee arthroplasty

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xianzuo Zhang, Ph.D; Phone Number: +8618556533086; Email: zhangxianzuo@foxmail.com
• Study Contact Backup: Name: Xianyue Shen, M.D; Phone Number: 17843122928; Email: shenxianyue0616@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • The First Affiliated hospital of USTC
      • Contact: Chen Zhu, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects voluntarily participate in the trial and sign the informed consent form;
2. Aged 18 to 80 years old (inclusive), regardless of gender;
3. Patients who need total knee replacement surgery;
4. Those who can communicate well with the researchers and comply with the trial requirements.

Exclusion Criteria:

1. Patients who are allergic to the drugs used in this trial or the implant materials;
2. Patients with immature bone development;
3. Patients with active infection;
4. Patients with neuropathy of the knee joint;
5. Patients with poor bone quality that is not conducive to prosthesis fixation;
6. Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
7. Patients with insufficient quadriceps muscle strength;
8. Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
9. Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
10. Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
11. Pregnant or lactating women;
12. Patients with severe epilepsy or mental illness;
13. Patients with alcohol dependence or drug addiction;
14. Patients with severe coagulation disorders;
15. Patients who have participated in or are participating in other clinical trials within one month of enrollment;
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted total knee arthroplasty; Using an orthopedic joint surgery navigation system to assist total knee replacement	Procedure: Robot-assisted surgery; Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
Active Comparator: Conventional total knee arthroplasty; Using a conventional 4-in-1 osteotomy guide for total knee replacement	Procedure: Conventional total knee arthroplasty; Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of Science and Technology of China
• Investigators: Principal Investigator: Chen Zhu, M.D, The First Affiliated hospital of USTC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: total knee arthroplasty; complication; alignment; robot-assisted; satisfication
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: XJS2023-1-18(WK)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No