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

NCT06955481 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Joint Diseases
  • Rheumatoid Arthritis of Knee
  • Posttraumatic Arthropathy

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.

Sponsors & Collaborators

  • Raylytic GmbH

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Jörg Lützner, Prof. Dr. · Universitätsklinikum Carl Gustav Carus

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2027-07-31
Completion
2028-06-30

Countries

  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955481 on ClinicalTrials.gov