Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Indication for a TKA with a fixed-bearing total knee endoprosthesis
• Written informed consent for participating in the clinical study
Locations
Other Locations
Germany
Bundeswehr Krankenhaus Ulm
RECRUITING
Ulm
Contact Information
Primary
Kristin Maier, Dr.
info@aesculap.de
+49746195
Backup
Marius Selig
info@aesculap.de
+49746195
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 140
Treatments
OrthoPilot® Elite
navigated / computer assisted total knee replacement surgery
MAKO
robot assisted total knee replacement surgery
Related Therapeutic Areas
Sponsors
Leads: Aesculap AG