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

Aesculap

Status: Enrolling

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

Treatments: Device: Navigated total knee arthroplasty; Device: Robot assisted total knee arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT05980442

AAG-O-H-23032

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

140 participants in 2 patient groups

OrthoPilot® Elite

Description:

navigated / computer assisted total knee replacement surgery

Treatment:

Device: Navigated total knee arthroplasty

MAKO

Description:

robot assisted total knee replacement surgery

Treatment:

Device: Robot assisted total knee arthroplasty