RecruitingNCT06955481

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

Sponsor

Aesculap AG

Enrollment

120 participants

Start Date

Oct 7, 2025

Study Type

OBSERVATIONAL

Conditions

Osteoarthritis, Knee Posttraumatic Arthropathy Joint Diseases Rheumatoid Arthritis of Knee

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the performance and long-term outcomes of a computer-assisted (navigated) knee replacement system called OrthoPilot pheno4u, combined with a specific knee implant. Researchers want to understand how well this navigation technology helps surgeons align the new knee joint for the best patient results. **You may be eligible if...** - You need a total knee replacement and your surgeon has decided to use the OrthoPilot navigation system with an Aesculap implant - You are between 18 and 80 years old - You are willing and mentally able to attend long-term follow-up appointments **You may NOT be eligible if...** - You are pregnant - You are under 18 or over 80 years old - You are not able to attend follow-up visits for physical or mental health reasons - You have previously had a knee replacement in the same joint - You have a serious health condition (classified as ASA IV or higher — meaning a life-threatening systemic disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENavigated 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.