Robot-assisted total knee replacement for osteoarthritis

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

This study tests if using a robot to help with knee replacement surgery can lead to better results and happier patients compared to traditional methods for those with severe knee osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China (Academic / other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06856356 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with end-stage knee osteoarthritis requiring total knee replacement.

Not a fit: Patients with active infections, severe deformities, or poor bone quality may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate knee replacements and improved patient satisfaction.

How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, indicating potential for success in this approach.

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.

Where this trial is running

Hefei, Anhui

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

Study contacts

• Principal investigator: Chen Zhu, M.D — The First Affiliated Hospital of USTC
• Study coordinator: Xianzuo Zhang, Ph.D

Conditions Osteoarthritis, Knee; total knee arthroplasty; robot-assisted; alignment; satisfication; complication