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RECRUITING
NCT05980442

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

Sponsor: Aesculap AG

View on ClinicalTrials.gov

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.

Official title: Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2024-07-03

Completion Date

2028-12

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

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