Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAesculap AG
About this trial
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.
Eligibility criteria
Qualifiers
Indication for a TKA with a fixed-bearing total knee endoprosthesis
Written informed consent for participating in the clinical study
Disqualifiers
Patient age <18 years and >90 years
Patient not willing to participate at the follow-up
Pregnancy
retropatellar arthrosis requiring patella resurfacing
Trial design
Treatments tested in this trial
- Navigated total knee arthroplasty
- Robot assisted total knee arthroplasty
Treatment groups
140 Participants
are divided into 2 treatment groupsLocations
1Bundeswehr Krankenhaus Ulm89081, UlmBaden-Wurttemberg, Germany
Sponsors and collaborators
Aesculap AG
Lead sponsor
Source ClinicalTrials.gov