RecruitingNCT05980442

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


Sponsor

Aesculap AG

Enrollment

140 participants

Start Date

Jul 3, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of technology-assisted knee replacement surgery: one that uses computer navigation (OrthoPilot Elite) versus one that uses a robotic arm (MAKO). The goal is to see which method leads to better outcomes for patients. **You may be eligible if:** - You need a total knee replacement surgery - You are between 18 and 90 years old - You are willing to attend follow-up appointments - You are able to provide written consent to participate **You may NOT be eligible if:** - You are under 18 or over 90 years old - You are pregnant - Your kneecap (patella) has severe arthritis requiring resurfacing - Your general health is poor enough to score above 3 on the anesthesia risk scale (ASA Classification) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENavigated total knee arthroplasty

Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system

DEVICERobot 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

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NCT05980442


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