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Recruiting NCT05980442

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

— Observational Osteoarthritis, Knee Joint Diseases Rheumatoid Arthritis of Knee Posttraumatic Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Navigated total knee arthroplasty, Robot assisted total knee arthroplasty.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Overview

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.

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

Primary outcome measures

  • Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component) [Time frame: one year postoperatively]
Secondary outcome measures (7)
  • Survival of the implant components [Time frame: one year postoperatively]
  • Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component) [Time frame: one year postoperatively]
  • Quality of Life [EQ-5D-5L] [Time frame: one year postoperatively]
  • Anterior knee pain [Time frame: one year postoperatively]
  • Comparison of Radiographic alignment [Time frame: one year postoperatively]
  • Comparison of Radiographic status [Time frame: one year postoperatively]
  • (Serious) Adverse Events [Time frame: During the course of the study up to one year postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Germany · 1 center
  • Bundeswehr Krankenhaus Ulm — Ulm

Identifiers

NCT: NCT05980442 · AAG-O-H-23032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗