Actively Recruiting
Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot Elite and Robotic-assisted MAKO Total Knee Arthroplasty
Led by Aesculap AG · Updated on 2026-03-27
140
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the safety and performance of two types of total knee arthroplasty (TKA) for people with knee osteoarthritis and related joint diseases. This study evaluates navigation-assisted OrthoPilot Elite and robotic-assisted MAKO TKA to see if both methods achieve similar functional and clinical outcomes. The goal is to understand how each technique affects knee function and patient recovery. Participants will undergo either navigated total knee replacement using the OrthoPilot Elite navigation system with Columbus total knee endoprosthesis or robot-assisted total knee replacement using the MAKO robot system with Triathlon total knee endoprosthesis. The study is randomized and controlled but observational, conducted at a single center. During the study, researchers will assess knee function using the Knee Society Score one year after surgery, along with implant survival, clinical outcomes, quality of life, anterior knee pain, and radiographic alignment and status. Adverse events will be monitored throughout the study up to one year post-operation. Participants will be followed for at least one year to evaluate these outcomes.
CONDITIONS
Brief Title
Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for a total knee arthroplasty with a fixed-bearing total knee endoprosthesis
- Written informed consent for participating in the clinical study
You will not qualify if you...
- Patient younger than 18 years or older than 90 years
- Patient not willing to participate at the follow-up
- Pregnancy
- Retropatellar arthrosis requiring patella resurfacing
- American Society of Anaesthesiologists (ASA) Classification greater than 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Hospital stay duration as per routine care
Participants undergo total knee replacement surgery using either the OrthoPilot® Elite navigation system or the MAKO® robot system, followed by immediate post-operative care.
1 surgery and immediate post-operative period
Duration - Up to 1 year postoperatively
Participants are monitored and assessed after surgery to evaluate functional and clinical outcomes, quality of life, implant survival, pain, radiographic status, and adverse events.
Approximately 1 year of follow-up visits
Trial Site Locations
Total: 1 location
1
Bundeswehr Krankenhaus Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
Research Team
K
Kristin Maier, Dr.
M
Marius Selig
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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