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Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
NCT06955481 · Aesculap AG
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1
About this study
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
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.)
Study design
Enrollment target: 120 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-10-07
Estimated completion: 2028-06
Last updated: 2025-11-17
Interventions
Procedure: Navigated Total Knee Arthroplasty
Primary outcomes
- • Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software (3 months post OP)
Sponsor
Aesculap AG · industry
With: Raylytic GmbH
Contacts & investigators
ContactHeike Oberascher · contact · studies@aesculap.de · +49 7461 95
ContactStefan Maenz, Dr. · contact · studies@aesculap.de · +49 7461 95
InvestigatorJörg Lützner, Prof. Dr. · principal_investigator, Universitätsklinikum Carl Gustav Carus
All locations (4)
Šumperk Hospital Inc.Not Yet Recruiting
Šumperk, Czechia
Klinikum Konstanz GmbHNot Yet Recruiting
Konstanz, Baden-Wurttemberg, Germany
Park-Klinik WeißenseeRecruiting
Berlin, Germany
Universitätsklinikum Carl Gustav CarusNot Yet Recruiting
Dresden, Germany