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

NCT05980442 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

  • Osteoarthritis, Knee
  • Joint Diseases
  • Rheumatoid Arthritis of Knee
  • Posttraumatic Arthropathy

Interventions

DEVICE

Navigated total knee arthroplasty

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

DEVICE

Robot assisted total knee arthroplasty

Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Hans-Joachim Riesner, PD Dr. med. · Bundeswehr Krankenhaus Ulm

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980442 on ClinicalTrials.gov