Clinical trial Recruiting at 1 site Observational Ages 18 to 90

Comparing two methods for total knee replacement surgery

Official title: Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Run by Aesculap AG · NCT05980442 · Data updated 2026-11-12

This study is testing two different knee replacement surgery methods to see if they both help patients recover and feel satisfied with their results.

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment140 (estimated)
SponsorAesculap AG
Industry-sponsored
Locations1 site (Ulm, Baden-Wurttemberg)
StatusRecruiting
StartedJuly 3, 2024
Main results expectedDecember 2027
Study endsDecember 2028
Registry record updatedMarch 27, 2026
Trial IDNCT05980442 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 to 90 who require total knee arthroplasty due to conditions like osteoarthritis or rheumatoid arthritis.

Probably not a fit

Patients with severe comorbidities classified as ASA >3 or those with specific knee conditions requiring additional procedures may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the safety and performance of two surgical techniques for total knee arthroplasty: navigation-assisted OrthoPilot Elite and robotic-assisted MAKO. It is a randomized, controlled, single-center study that will assess the clinical outcomes and functional results of both approaches. The hypothesis is that both techniques will yield similar results in terms of patient recovery and satisfaction. Participants will be monitored for their progress following the surgery.

Why it matters

Potential benefit: If successful, this study could help determine the most effective surgical method for total knee replacement, potentially improving patient outcomes.

How similar studies have gone: Previous studies comparing robotic-assisted and navigation-assisted techniques have shown promising results, indicating that both methods can be effective, but this specific comparison is less common.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Bundeswehr Krankenhaus Ulm
    Ulm, Baden-Wurttemberg, Germany
    Recruiting

Study contacts

  • Principal investigator: Hans-Joachim Riesner, PD Dr. med. — Bundeswehr Krankenhaus Ulm
  • Study coordinator: Kristin Maier, Dr.
  • Email: info@aesculap.de
  • Phone: +49746195

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.