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

NCT06955481 | Recruiting

• 1 other identifier: AAG-O-H-25084
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 4

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.

Conditions

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

Keywords

Navigation; Total Knee Arthroplasty; OrthoPilot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Implant survival

  ongoing, up to 2 years follow-up

• Oxford Knee Score (OKS)

  Preoperative,3 months-, 12 months and 2 years post operative

• Forgotten Joint Score (FJS)

  Preoperative,3 months-, 12 months and 2 years post operative

• Quality of Life (EQ-5D-5L)

  Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months

• NET Promotor Score (NPS)

  Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months

Study Arms (1)

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

Interventions

Navigated Total Knee Arthroplasty PROCEDURE

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.

pheno4u TKA Level 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Aesculap AG: lead
• Raylytic GmbH: collaborator

Study Sites (4)

Šumperk Hospital Inc.

Šumperk, 78701, Czechia

NOT YET RECRUITING

Klinikum Konstanz GmbH

Konstanz, Baden-Wurttemberg, 78464, Germany

NOT YET RECRUITING

Park-Klinik Weißensee

Berlin, 13086, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jörg Lützner, Prof. Dr.

  Universitätsklinikum Carl Gustav Carus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heike Oberascher

CONTACT

+49 7461 95; studies@aesculap.de

Stefan Maenz, Dr.

CONTACT

+49 7461 95; studies@aesculap.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CZ (1); DE (3)