Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Recruiting · NCT06955481 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aesculap AG
View the official record on ClinicalTrials.gov →Interventions studied
Navigated Total Knee Arthroplasty
What this trial is 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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
4 locations listed.
- Park-Klinik Weißensee - Berlin, Germany
- Universitätsklinikum Carl Gustav Carus - Dresden, Germany
- Šumperk Hospital Inc. - Šumperk, Czechia
- Klinikum Konstanz GmbH - Konstanz, Baden-Wurttemberg, Germany