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 |
Trial Parameters
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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; 1