RecruitingNCT06955481

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

Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1

Sponsor

Aesculap AG

Enrollment

120 participants

Start Date

Oct 7, 2025

Study Type

OBSERVATIONAL

Conditions

Osteoarthritis, Knee Posttraumatic Arthropathy Joint Diseases Rheumatoid Arthritis of Knee

Summary

The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance. Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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 Criteria5

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.)

Interventions

PROCEDURENavigated Total Knee Arthroplasty

The OrthoPilot® Software Pheno4u TKA Level 1 is an application software for computer aided navigation of surgical instruments and serves (in combination with compatible hardware and compatible navigated instruments) as an optional aid for the surgeon during the preparation of the implant site for a compatible knee endoprosthesis.