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RECRUITING
NCT06955481

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-10-07

Completion Date

2028-06

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

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