Clinical trial NCT06955481: Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis, Knee
Joint Diseases
Rheumatoid Arthritis of Knee
Posttraumatic Arthropathy
Keywords: Navigation
Total Knee Arthroplasty
OrthoPilot
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Raylytic GmbH
First posted: 2025-05-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.)

Primary outcomes:
measure: Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software
timeFrame: 3 months post OP
Secondary outcomes:
measure: Implant survival
timeFrame: ongoing, up to 2 years follow-up
measure: Oxford Knee Score (OKS)
timeFrame: Preoperative,3 months-, 12 months and 2 years post operative
measure: Forgotten Joint Score (FJS)
timeFrame: Preoperative,3 months-, 12 months and 2 years post operative
measure: Quality of Life (EQ-5D-5L)
timeFrame: Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
measure: NET Promotor Score (NPS)
timeFrame: Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
measure: Anterior knee pain
timeFrame: Preoperative,3 months-, 12 months and 2 years post operative
measure: Radiological results
timeFrame: Preoperative, Discharge, 1 year post op
measure: All (Serious) Adverse Events
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: