Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAesculap AG
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Navigated Total Knee Arthroplasty
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Aesculap AG
Lead sponsor
Raylytic GmbH
Collaborator
Source ClinicalTrials.gov