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NCT05980442Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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 of the study is the comparison of the clinical outcome between navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.

Status (registry)
Recruiting
Study type
Observational
Enrollment
140 (estimated)
First submitted
19 Jul 2023
Start date
3 Jul 2024
Primary completion date
Dec 2027
Lead sponsor
Aesculap AG
NCT number
NCT05980442

What you commit to

  • Study type: Observational
  • Planned participants: 140
  • From 3 Jul 2024 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Patient age \<18 years and \>90 years

Other

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

Who the study is looking for

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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bundeswehr Krankenhaus Ulm
Coordinator of this site? Confirm its status
UlmGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.