NCT06856356 Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty
| NCT ID | NCT06856356 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of University of Science and Technology of China |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-04-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Chen Zhu, M.D
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Frequently Asked Questions
Who can join the NCT06856356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06856356 currently recruiting?
Yes, NCT06856356 is actively recruiting participants. Contact the research team at zhangxianzuo@foxmail.com for enrollment information.
Where is the NCT06856356 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06856356 clinical trial?
NCT06856356 is sponsored by The First Affiliated Hospital of University of Science and Technology of China. The principal investigator is Chen Zhu, M.D at The First Affiliated Hospital of University of Science and Technology of China. The trial plans to enroll 40 participants.