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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are planned for a total knee replacement using the OrthoPilot navigation system with an Aesculap knee implant.
- Age
- 18 to 80 years
- Sex
- All sexes can join
- Disease stage
- Knee osteoarthritis, rheumatoid arthritis of the knee, or joint damage after an injury, with an indication for total knee replacement
- Earlier treatment
- No earlier joint replacement on the same knee
Main reasons for not taking part
- Pregnancy
- Younger than 18 years or older than 80 years
- Cannot take part in the follow-up visits, physically or mentally
- Earlier joint replacement on the same knee
- ASA classification higher than 3
Read by machine on 12 November 2026.
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, GermanyContact: Oliver Hauschild, Prof.Dr.medTaking people
- Universitätsklinikum Carl Gustav CarusDresden, GermanyContact: Jörg Lützner, Prof. Dr.Not yet recruiting
- Klinikum Konstanz GmbHKonstanz, GermanyContact: Gunnar Ochs, Prof.Dr.medNot 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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).