Actively Recruiting
Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Led by Aesculap AG · Updated on 2025-11-17
120
Participants Needed
4
Research Sites
138 weeks
Total Duration
On this page
Sponsors
A
Aesculap AG
Lead Sponsor
R
Raylytic GmbH
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for total knee arthroplasty with the OrthoPilot® Navigation System using an Aesculap total knee endoprosthesis
- Signed informed consent from the patient
- Willingness and mental ability to participate in long-term follow-up examinations
You will not qualify if you...
- Pregnancy
- Age under 18 years or over 80 years
- Inability to participate in follow-up examinations due to physical or mental reasons
- Previous joint replacement in the knee to be operated on
- ASA classification greater than 3 (patients with severe systemic disease causing functional limitations or worse)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Šumperk Hospital Inc.
Šumperk, Czechia, 78701
Not Yet Recruiting
2
Klinikum Konstanz GmbH
Konstanz, Baden-Wurttemberg, Germany, 78464
Not Yet Recruiting
3
Park-Klinik Weißensee
Berlin, Germany, 13086
Actively Recruiting
4
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Not Yet Recruiting
Research Team
H
Heike Oberascher
CONTACT
S
Stefan Maenz, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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