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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Indication for a TKA with a fixed-bearing total knee endoprosthesis - Written willing to sign a consent form for participating in the clinical study Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Navigated total knee arthroplasty

Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system

DEVICE

Robot assisted total knee arthroplasty

Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system

Locations (1)

Bundeswehr Krankenhaus Ulm
Ulm, Baden-Wurttemberg, Germany