Robot-assisted total knee replacement for osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Orthopedic Joint Surgery Navigation System in assisting surgeons during total knee replacement surgery for patients with end-stage knee osteoarthritis. The study compares the accuracy of prosthetic component placement using this robotic system against traditional knee replacement methods. Participants will undergo surgery and be monitored for satisfaction, functional scores, and any complications over a period of time. The goal is to determine if the robotic approach offers superior outcomes in terms of alignment and patient satisfaction.

Why it matters

Who can join: the full rules

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.

Where it's running

• the first affiliated hospital of USTC
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Chen Zhu, M.D — The First Affiliated Hospital of University of Science and Technology of China
• Study coordinator: Xianzuo Zhang, Ph.D
• Email: zhangxianzuo@foxmail.com
• Phone: +8618556533086

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.