Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

Launched by THE FIRST AFFILIATED HOSPITAL OF UNIVERSITY OF SCIENCE AND TECHNOLOGY OF CHINA · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new technology called the Orthopedic Joint Surgery Navigation System, which helps surgeons place knee replacement parts more accurately during surgery. The goal is to see how effective and safe this system is for people who need total knee replacement due to osteoarthritis, a common condition that causes joint pain and stiffness. The trial is currently recruiting participants aged 18 to 80 who are in need of this type of surgery and can communicate with the research team.

If you or someone you know might be interested in participating, it's important to know that there are certain criteria to meet. Eligible participants should be in good enough health to undergo surgery and not have any serious medical issues that could complicate the procedure. Those who have allergies to the materials used in the surgery, certain bone conditions, or other specific health concerns may not qualify. Participants can expect to contribute to important research that could improve knee surgery outcomes while receiving care from a professional team throughout the process.

Gender

ALL

Eligibility criteria

• 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.