Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
NCT ID: NCT06955481
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-10-07
2028-06-30
Brief Summary
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Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pheno4u TKA Level 1
Navigation of TKA (Total Knee Arthroplasty) using the new pheno4uTKA Level 1 software for OrthoPilot Elite®.
Navigated Total Knee Arthroplasty
The OrthoPilot® Software Pheno4u TKA Level 1 is an application software for computer aided navigation of surgical instruments and serves (in combination with compatible hardware and compatible navigated instruments) as an optional aid for the surgeon during the preparation of the implant site for a compatible knee endoprosthesis.
Interventions
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Navigated Total Knee Arthroplasty
The OrthoPilot® Software Pheno4u TKA Level 1 is an application software for computer aided navigation of surgical instruments and serves (in combination with compatible hardware and compatible navigated instruments) as an optional aid for the surgeon during the preparation of the implant site for a compatible knee endoprosthesis.
Eligibility Criteria
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Inclusion Criteria
* Written signed informed consent of patient
* Willingness and mental ability to participate at the long-term follow-up examinations
Exclusion Criteria
* 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.)
18 Years
80 Years
ALL
No
Sponsors
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Raylytic GmbH
INDUSTRY
Aesculap AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jörg Lützner, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Carl Gustav Carus
Locations
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Šumperk Hospital Inc.
Šumperk, , Czechia
Klinikum Konstanz GmbH
Konstanz, Baden-Wurttemberg, Germany
Park-Klinik Weißensee
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Countries
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Central Contacts
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Facility Contacts
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Ján Debre, Dr.med
Role: primary
Role: backup
Gunnar Ochs, Prof.Dr.med
Role: primary
Oliver Hauschild, Prof.Dr.med
Role: primary
Jörg Lützner, Prof. Dr.
Role: primary
Other Identifiers
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AAG-O-H-25084
Identifier Type: -
Identifier Source: org_study_id
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