Status:

RECRUITING

Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Lead Sponsor:

Aesculap AG

Conditions:

Osteoarthritis, Knee

Joint Diseases

Eligibility:

All Genders

18-90 years

Brief Summary

Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA). The aim...

Eligibility Criteria

Inclusion

  • Indication for a TKA with a fixed-bearing total knee endoprosthesis
  • Written informed consent for participating in the clinical study

Exclusion

  • Patient age \<18 years and \>90 years
  • Patient not willing to participate at the follow-up
  • Pregnancy
  • retropatellar arthrosis requiring patella resurfacing
  • American Society of Anaesthesiologists (ASA) Classification \>3

Key Trial Info

Start Date :

July 3 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT05980442

Start Date

July 3 2024

End Date

December 1 2026

Last Update

January 8 2026

Active Locations (1)

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Bundeswehr Krankenhaus Ulm

Ulm, Baden-Wurttemberg, Germany, 89081