RecruitingNot Applicable

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

Germany140 participantsStarted 2024-07-03

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)

Timeframe: one year postoperatively

Trial details

NCT IDNCT05980442

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Kristin Maier, Dr.

+49746195 info@aesculap.de

View on ClinicalTrials.gov More Osteoarthritis, Knee trials