Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1 (TKA4U)

Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Diseases; Osteoarthritis, Knee; Rheumatoid Arthritis of Knee; Posttraumatic Arthropathy
• Intervention / Treatment: Procedure: Navigated Total Knee Arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Heike Oberascher; Phone Number: +49 7461 95; Email: studies@aesculap.de
• Study Contact Backup: Name: Stefan Maenz, Dr.; Phone Number: +49 7461 95; Email: studies@aesculap.de

Study Locations

• Czechia
  • Šumperk, Czechia, 78701
    • Not yet recruiting
    • Šumperk Hospital Inc.
    • Contact: Ján Debre, Dr.med
    • Contact: Phone Number: +420 583 333
    • Principal Investigator: Ján Debre, Dr. med
• Germany
  • Berlin, Germany, 13086
    • Recruiting
    • Park-Klinik Weißensee
    • Contact: Oliver Hauschild, Prof.Dr.med; Phone Number: +49 7531 801
    • Principal Investigator: Oliver Hauschild, Prof. Dr.
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Universitatsklinikum Carl Gustav Carus
    • Principal Investigator: Jörg Lützner, Prof. Dr.
    • Contact: Jörg Lützner, Prof. Dr.; Phone Number: +49 351 458 150
  • Baden-Wurttemberg
    • Konstanz, Baden-Wurttemberg, Germany, 78464
      • Not yet recruiting
      • Klinikum Konstanz GmbH
      • Contact: Gunnar Ochs, Prof.Dr.med; Phone Number: +49 7531 801
      • Principal Investigator: Gunnar Ochs, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients between 18 and 80 years of age having indication for a fixed-bearing total knee endoprosthesis, without retropatellar arthrosis requiring patella resurfacing

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pheno4u TKA Level 1; Navigation of TKA (Total Knee Arthroplasty) using the new pheno4uTKA Level 1 software for OrthoPilot Elite®.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software	The primary variable delta (aHKA), is defined as the difference in the arithmetic hip-knee-angle (aHKA) between the 3 months postoperative and the intraoperatively planned value. The aHKA is calculated as the difference of the mechanical medial proximal tibial angle (MPTA) and the mechanical lateral distal femoral angle (LDFA), both measured in degrees.	3 months post OP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	Secondary interventions at the index knee	ongoing, up to 2 years follow-up
Oxford Knee Score (OKS)	The Oxford Knee Score (OKS) is a validated joint-specific patient-reported outcome measure that is commonly employed to assess the outcome of TKA. It is a 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing TKA. It is short, reproducible, valid and sensitive to clinically important changes over time. OKS ranges from 0 to 48 with 48 being the best outcome.	Preoperative,3 months-, 12 months and 2 years post operative
Forgotten Joint Score (FJS)	The FJS-12 contains 12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48*100). Lower scores indicate less awareness of the operated knee during daily activities. The range of the final score is from 0 to 100 (where 0 is worst and 100 means best score)	Preoperative,3 months-, 12 months and 2 years post operative
Quality of Life (EQ-5D-5L)	Quality of life of the patients will be analyzed using the 5-dimensions 5-level measure of the EuroQol Group (EQ-5D-5L), which is a simple and generic measure for clinical and economic assessment. The questionnaire covers five different dimensions (mobility, self-care, usual activities,pain/discomfort, anxiety/depression) rated in 5 levels (from "the worst health you can imagine" to "the best health you can imagine"). The questionnaire is filled by the patients themselves.	Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
NET Promotor Score (NPS)	The Net Promoter Score (NPS) was developed for measuring satisfaction in economic research. Colloquially, it is referred to as the "friends and family test". In the healthcare sector, the NPS is used as an overarching measure of patient satisfaction. The NPS metric evaluates the likelihood that a patient will recommend the received healthcare service to others. The NPS is assessed using a scale from 1 to 10. A rating between 9 and 10 is classified as a promoter. A rating between 7 and 8 is considered neutral, and a rating between 0 and 6 is deemed a detractor. The overall score is simply calculated by subtracting the percentage of detractors from the percentage of promoters. Scores range from -100 (everyone is a detractor) to +100 (everyone is a promoter). In the industry, a positive score is viewed favorably, and scores above 50 are considered indicative of strong performance.	Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
Anterior knee pain	Anterior knee pain will be used to evaluate the performance of the implantation and the implant itself. Rating Description Points: 0 = No pain (0 Points) I = Mild pain that does not intrude on daily activities (5 Points) II= Moderate pain that is a nuisance; patient not considering further surgery (10 Points) III= Severe pain; patient considering further surgery (15 Points)	Preoperative,3 months-, 12 months and 2 years post operative
All (Serious) Adverse Events	During the course of the study, any upcoming intra- or postoperative (serious) adverse will be documented. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed to assess the safety of the investigational product.	2 years
Radiological results	Routinely performed radiographic images are used to evaluate the status of the affected knee, preoperatively, and the status of the implant components, postoperatively. Analysis of parameters will be defined in the radiographic protocol, where precise definition of the implant alignment parameter of the tibial and femoral component by measurement of the LDFA (laterale distale Femurankle) and MPTA (medial proximal Tibiaankle) is given. Both ankles have the same unit and are measured in degrees.	Preoperative, Discharge, 1 year post op

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: Raylytic GmbH
• Investigators: Principal Investigator: Jörg Lützner, Prof. Dr., Universitatsklinikum Carl Gustav Carus

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Navigation; OrthoPilot
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Osteoarthritis; Joint Diseases; Osteoarthritis, Knee
• Other Study ID Numbers: AAG-O-H-25084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No