Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1 (TKA4U)

Aesculap

Status

Enrolling

Conditions

Joint Diseases

Rheumatoid Arthritis of Knee

Posttraumatic Arthropathy

Osteoarthritis, Knee

Treatments

Procedure: Navigated Total Knee Arthroplasty

Study type

Observational

Funder types

Industry

Identifiers

NCT06955481

AAG-O-H-25084

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.)