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Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1 | Clinical Trials | Clareo Health

RECRUITING

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

NCT06955481•Aesculap AG

View on ClinicalTrials.gov

Summary

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.)

Locations (4)

Šumperk Hospital Inc.

Šumperk, Czechia

Klinikum Konstanz GmbH

Konstanz, Baden-Wurttemberg, Germany

Park-Klinik Weißensee

Berlin, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Key Dates

Start Date

October 7, 2025

Primary Completion Date

July 1, 2027

Completion Date

June 1, 2028

Last Updated

November 17, 2025

Enrollment

120

ESTIMATED participants

Conditions

Osteoarthritis, KneeJoint DiseasesRheumatoid Arthritis of KneePosttraumatic Arthropathy

Interventions

Navigated Total Knee Arthroplasty

PROCEDURE

Contacts

Heike Oberascher

CONTACT

+49 7461 95 studies@aesculap.de

Stefan Maenz, Dr.

CONTACT

+49 7461 95 studies@aesculap.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1

Inclusion Criteria

Exclusion Criteria

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