NCT05980442

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Joint Diseases
• Rheumatoid Arthritis of Knee
• Posttraumatic Arthropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-03
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2023-08-08
• Last updated: 2026-03-27

Locations

1 site across 1 country: Germany