NCT06955481Recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 25 Apr 2025
- Start date
- 7 Oct 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- Aesculap AG
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06955481
What you commit to
- Study type: Observational
- Planned participants: 120
- From 7 Oct 2025 to the primary completion date, Jul 2027
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous joint replacement at the index knee
Other illness
- 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.)
Age
- Patients \< 18 years or \> 80 years
Other
- Pregnancy
- Patients unable to participate at the follow-up examination (physically, mentally)
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Šumperk Hospital Inc. Coordinator of this site? Confirm its status | Šumperk | Czechia | Not yet recruiting |
| Park-Klinik Weißensee Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitätsklinikum Carl Gustav Carus Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Klinikum Konstanz GmbH Coordinator of this site? Confirm its status | Konstanz | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.