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
Aesculap AG
140 participants
Jul 3, 2024
OBSERVATIONAL
Conditions
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 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
Inclusion Criteria2
- Indication for a TKA with a fixed-bearing total knee endoprosthesis
- Written informed consent for participating in the clinical study
Exclusion Criteria5
- 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
Interventions
Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system
Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05980442