Actively Recruiting

Phase Not Applicable
Age: 40Years - 90Years
All Genders
NCT06280352

Robotic Assisted vs Custom Made Total Knee Arthroplasty

Led by Austrian Workers Compensation Board Styria · Updated on 2025-01-28

120

Participants Needed

2

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are: * Which implant/philosophy yields better clinical outcomes? * Which implant/philosophy yields better satisfaction? * Which system is more OR efficient? Participants will be followed for 2 years postoperatively.

CONDITIONS

Official Title

Robotic Assisted vs Custom Made Total Knee Arthroplasty

Who Can Participate

Age: 40Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is male or non-pregnant female aged 40 to 90 years
  • Requires a primary total knee replacement
  • Appropriate for a cruciate retaining knee replacement
  • Primary diagnosis of osteoarthritis
  • Has intact collateral ligaments
  • Able to undergo CT scanning of the affected limb
  • Signed ethics-approved informed consent
  • Willing and able to follow pre- and post-operative clinical and radiographic evaluations
Not Eligible

You will not qualify if you...

  • History of total, unicompartmental reconstruction, or fusion of the affected joint
  • Previous osteotomy around the knee
  • Morbid obesity (BMI greater than 41)
  • Deformity requiring use of stems, wedges, or augments
  • Varus deformity of 15 degrees or more
  • Valgus deformity greater than 3 degrees
  • Neuromuscular or neurosensory deficiency limiting device performance assessment
  • Unable to speak German
  • Pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

AUVA UKH Steiermark Standort Graz

Graz, Styria, Austria, 8020

Actively Recruiting

2

AUVA UKH Steiermark Standort Kalwang

Kalwang, Styria, Austria, 8775

Actively Recruiting

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Research Team

A

Antonio Klasan, MD, PhD, EMBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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