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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis - Written signed willing to sign a consent form of patient - Willingness and mental ability to participate at the long-term follow-up examinations Who Should NOT Join This Trial: - 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.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.)

Treatments Being Tested

PROCEDURE

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.

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