Clinical Trial

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

Study acronym: ORMAK
Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-07-28; most recent amendment 2026-03-26.
Status change: Not Yet Recruiting → Recruiting 2024-07-03
Trial Details
NCT Number NCT05980442
Lead Sponsor Aesculap AG
Conditions Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
Enrollment 140 participants
Start Date 2024-07-03
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-27