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

Recruiting now

Conditions studied: Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy

In brief

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.

Key facts

Study ID

NCT05980442

Run by

Aesculap AG

People needed

140

Starts

2024-07-03

Expected to finish

2028-12-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

• Bundeswehr Krankenhaus Ulm — Ulm, Baden-Wurttemberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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