Osteoarthritis, KneeJoint DiseasesRheumatoid Arthritis of KneePosttraumatic Arthropathy
Investigational drug(s) / intervention(s)
Navigated total knee arthroplastyRobot assisted total knee arthroplasty
Navigated total knee arthroplasty: Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system
Robot assisted total knee arthroplasty: Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system
Study 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
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component) — one year postoperatively Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA.
It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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