Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Recruiting · NCT05980442 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aesculap AG
View the official record on ClinicalTrials.gov →Interventions studied
Navigated total knee arthroplastyRobot assisted total knee arthroplasty
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed.
- Bundeswehr Krankenhaus Ulm - Ulm, Baden-Wurttemberg, Germany
- Bundeswehr Krankenhaus Ulm - Ulm, Baden-Wurttemberg, Germany