NCT06955481 Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
| NCT ID | NCT06955481 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Osteoarthritis, Knee |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-07 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-10-07 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.)
Contact & Investigator
Jörg Lützner, Prof. Dr.
PRINCIPAL INVESTIGATOR
Universitätsklinikum Carl Gustav Carus
Frequently Asked Questions
Who can join the NCT06955481 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06955481 currently recruiting?
Yes, NCT06955481 is actively recruiting participants. Contact the research team at studies@aesculap.de for enrollment information.
Where is the NCT06955481 trial being conducted?
This trial is being conducted at Šumperk, Czechia, Konstanz, Germany, Berlin, Germany, Dresden, Germany.
Who is sponsoring the NCT06955481 clinical trial?
NCT06955481 is sponsored by Aesculap AG. The principal investigator is Jörg Lützner, Prof. Dr. at Universitätsklinikum Carl Gustav Carus. The trial plans to enroll 120 participants.