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Taking people in GermanyNo phase

Compares two computer-assisted methods for knee replacement surgery

Compares navigation-assisted and robot-assisted knee replacement in adults with knee arthritis.

Plain-language title generated from the registry record
Registry title: Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Key facts

Where
Ulm, GermanySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who need a total knee replacement with a fixed-bearing knee implant. It compares navigation-assisted and robot-assisted knee replacement surgery.

Age
18 to 90 years
Sex
Women and men can both join.
Disease stage
Knee problems such as osteoarthritis, rheumatoid arthritis or joint damage after injury, needing a total knee replacement with a fixed-bearing implant.

Main reasons for not taking part

  • Under 18 or over 90 years of age
  • Not willing to attend the follow-up visits
  • Pregnancy
  • Arthrosis behind the kneecap that needs the kneecap surface to be replaced
  • ASA (anaesthesia risk) class above 3

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 90 years old?

Source: NCT05980442, who can take part

Where in Germany

  • Bundeswehr Krankenhaus UlmUlm, GermanyContact: Hans-Joachim Riesner, PD Dr. med.Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Aesculap AG
Trial code
NCT05980442
Record updated
27 March 2026
Original description
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.Read full original descriptionShow less

Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance 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 (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.

Inclusion: Indication for a TKA with a fixed-bearing total knee endoprosthesis; Written informed consent for participating in the clinical study.

Exclusion: 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.

ClinicalTrials.gov NCT05980442