Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1

Launched by AESCULAP AG · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate a new technology called the OrthoPilot® pheno4u TKA Level 1 software, which helps guide knee replacement surgeries for patients with conditions like osteoarthritis and rheumatoid arthritis. The main goal is to see how accurate and safe this navigation system is during total knee arthroplasty (TKA), which is the medical term for knee replacement surgery. Researchers will also gather feedback from participants about their recovery and satisfaction after the surgery.

To participate in this study, you should be between the ages of 65 and 80 years and need a knee replacement using the OrthoPilot® system. You must be able to understand and agree to participate, and you should be able to attend follow-up appointments after your surgery. However, if you are pregnant, under 18, or have previously had surgery on the same knee, you would not be eligible to join. The trial is not yet recruiting participants, but it will be an important step in improving the care of patients undergoing knee replacement surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis
• • Written signed informed consent of patient
• • Willingness and mental ability to participate at the long-term follow-up examinations
• Exclusion Criteria:
• • Pregnancy
• • Patients \< 18 years or \> 80 years
• • Patients unable to participate at the follow-up examination (physically, mentally)
• • Previous joint replacement at the index knee
• • ASA classification \> 3 ( ASA I: A healthy patient without systemic diseases. ASA II: A patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). ASA III: A patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, COPD). ASA IV: A patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). ASA V: A dying patient who is not expected to survive without the operation. ASA VI: A deceased patient whose organs are being removed for donation.)