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Search / Trial NCT05980442

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

Launched by AESCULAP AG · Jul 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Computer Assisted Orthopedic Surgery Robotic Assisted Orthopedic Surgery Orthopedic Navigation Total Knee Arthroplasty Total Knee Replacement

ClinConnect Summary

This clinical trial is studying two different methods for performing total knee replacement surgery: one using navigation technology called OrthoPilot® Elite and the other using robotic assistance called MAKO®. The goal is to see if both methods are equally effective and safe for patients suffering from knee conditions like osteoarthritis and rheumatoid arthritis.

To join the study, participants should be between 65 and 90 years old and need a total knee replacement. They must also be willing to provide written consent and attend follow-up appointments after the surgery. If someone is under 18, over 90, pregnant, or has certain other medical issues, they might not be eligible. If you participate, you can expect to receive either the navigation-assisted or robotic-assisted surgery and will help researchers understand which method works better for patients like you.

Gender

ALL

Eligibility criteria

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

About Aesculap Ag

Aesculap AG is a prominent global medical device manufacturer specializing in surgical instruments, implants, and innovative healthcare solutions. With a rich history rooted in excellence and innovation, Aesculap AG is dedicated to advancing surgical practices through cutting-edge technology and a commitment to improving patient outcomes. The company collaborates with healthcare professionals and institutions to conduct clinical trials that evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of quality and performance. Through its rigorous research and development initiatives, Aesculap AG aims to contribute significantly to the field of medicine and enhance the standards of surgical care worldwide.

Locations

Ulm, Baden Württemberg, Germany

Ulm, , Germany

Patients applied

0 patients applied

Trial Officials

Hans-Joachim Riesner, PD Dr. med.

Principal Investigator

Bundeswehr Krankenhaus Ulm

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported