Navigated total knee replacement using 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
This project will test whether the OrthoPilot pheno4u TKA Level 1 navigation software improves the accuracy and safety of navigated total knee replacement for adults (18–80) with osteoarthritis or other knee joint problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 4 sites (Šumperk and 3 other locations) |
| Trial ID | NCT06955481 on ClinicalTrials.gov |
What this trial studies
This post‑market clinical follow-up is an observational, multi‑center project using the OrthoPilot Elite system with the new pheno4u TKA Level 1 navigation software during navigated total knee arthroplasty procedures. Surgeons will use the navigation software during routine TKA and the study will record navigation accuracy, intraoperative data, complications, and device‑related events. Patient‑reported outcome measures (PROMs) and functional outcomes will be collected at follow‑up visits to capture satisfaction and recovery. The study enrolls adults aged 18–80 indicated for a primary TKA with the specified implant and excludes patients with prior knee replacement, ASA class >3, pregnancy, or inability to complete follow‑up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 who need a primary total knee arthroplasty with the Aesculap implant using the OrthoPilot navigation system, can give informed consent, and can attend long‑term follow‑up visits.
Not a fit: Patients unlikely to benefit include those under 18 or over 80, pregnant patients, those with prior replacement of the index knee, ASA class >3, or individuals unable to participate in follow‑up examinations.
Why it matters
Potential benefit: If successful, the navigation software could lead to more accurate implant positioning, better function and satisfaction, and potentially longer prosthesis survival.
How similar studies have performed: Navigation‑assisted total knee arthroplasty has been used in many studies and often improves implant alignment, though evidence for consistent long‑term clinical advantage is mixed and this software version requires post‑market performance data.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Šumperk and 3 other locations
- Šumperk Hospital Inc. — Šumperk, Czechia (Not_yet_recruiting)
- Klinikum Konstanz GmbH — Konstanz, Baden-Wurttemberg, Germany (Not_yet_recruiting)
- Park-Klinik Weißensee — Berlin, Germany (Recruiting)
- Universitätsklinikum Carl Gustav Carus — Dresden, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Jörg Lützner, Prof. Dr. — Universitätsklinikum Carl Gustav Carus
- Study coordinator: Heike Oberascher
- Email: studies@aesculap.de
- Phone: +49 7461 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.