Navigated total knee replacement using OrthoPilot pheno4u TKA Level 1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post‑market clinical follow-up is an observational, multi‑center project using the OrthoPilot Elite system with the new pheno4u TKA Level 1 navigation software during navigated total knee arthroplasty procedures. Surgeons will use the navigation software during routine TKA and the study will record navigation accuracy, intraoperative data, complications, and device‑related events. Patient‑reported outcome measures (PROMs) and functional outcomes will be collected at follow‑up visits to capture satisfaction and recovery. The study enrolls adults aged 18–80 indicated for a primary TKA with the specified implant and excludes patients with prior knee replacement, ASA class >3, pregnancy, or inability to complete follow‑up.

Why it matters

Who can join: the full rules

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.)

Where it's running

• Park-Klinik Weißensee
  Berlin, Germany Recruiting
• Šumperk Hospital Inc.
  Šumperk, Czechia Not yet recruiting
• Klinikum Konstanz GmbH
  Konstanz, Baden-Wurttemberg, Germany Not yet recruiting
• Universitätsklinikum Carl Gustav Carus
  Dresden, Germany Not yet recruiting

Study contacts

• Principal investigator: Jörg Lützner, Prof. Dr. — Universitätsklinikum Carl Gustav Carus
• Study coordinator: Heike Oberascher
• Email: studies@aesculap.de
• Phone: +49 7461 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.