Menu
Recruiting NCT06955481

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

— Observational Osteoarthritis, Knee Joint Diseases Rheumatoid Arthritis of Knee Posttraumatic Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Navigated Total Knee Arthroplasty.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software [Time frame: 3 months post OP]
Secondary outcome measures (8)
  • Implant survival [Time frame: ongoing, up to 2 years follow-up]
  • Oxford Knee Score (OKS) [Time frame: Preoperative,3 months-, 12 months and 2 years post operative]
  • Forgotten Joint Score (FJS) [Time frame: Preoperative,3 months-, 12 months and 2 years post operative]
  • Quality of Life (EQ-5D-5L) [Time frame: Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months]
  • NET Promotor Score (NPS) [Time frame: Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months]
  • Anterior knee pain [Time frame: Preoperative,3 months-, 12 months and 2 years post operative]
  • Radiological results [Time frame: Preoperative, Discharge, 1 year post op]
  • All (Serious) Adverse Events [Time frame: 2 years]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 3 centers
  • Klinikum Konstanz GmbH — Konstanz
  • Park-Klinik Weißensee — Berlin
  • Universitätsklinikum Carl Gustav Carus — Dresden
Czechia · 1 center
  • Šumperk Hospital Inc. — Šumperk

Identifiers

NCT: NCT06955481 · AAG-O-H-25084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗