Checks Accuracy of Computer-Guided Knee Replacement Surgery
Tests a computer-guided software system during knee replacement in adults with knee joint disease.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Key facts
- Where
- Berlin, Dresden, and Konstanz, GermanySee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06955481, who can take part
Where in Germany
- Park-Klinik WeißenseeBerlin, GermanyTaking people
- Universitätsklinikum Carl Gustav CarusDresden, GermanyNot yet recruiting
- Klinikum Konstanz GmbHKonstanz, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aesculap AG
- Trial code
- NCT06955481
- Record updated
- 17 November 2025
- Original description
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.Read full original descriptionShow less
Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1
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.
Inclusion: 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: 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.); Patients < 18 years or > 80 years; Pregnancy; Patients unable to participate at the follow-up examination (physically, mentally).