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Taking people in AustriaNo phase

Robotic Assisted vs Custom Made Total Knee Arthroplasty

Key facts

Where
Graz and Kalwang, AustriaSee the 2 sites

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 40 and 90 years old?

Source: NCT06280352, who can take part

Where in Austria

  • AUVA UKH Steiermark Standort GrazGraz, AustriaContact: Antonio Klasan, MD, PHD, EMBATaking people
  • AUVA UKH Steiermark Standort KalwangKalwang, AustriaContact: Antonio Klasan, MD, PhD, EMBATaking 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
Austrian Workers Compensation Board Styria
Trial code
NCT06280352
Record updated
28 January 2025
Original description
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:Read full original descriptionShow less

Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty

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.

Inclusion: - The patient is a male or non-pregnant female between the ages of 40 and 90 years; The patient requires a primary total knee replacement; Patient is deemed appropriate for a cruciate retaining knee replacement; The patient has a primary diagnosis of osteoarthritis (OA); The patient has intact collateral ligaments; The patient is able to undergo CT scanning of the affected limb; The patient has signed the study specific, ethics-approved, informed consent document; The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion: Patient has had a previous osteotomy around the knee; - The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint; The patient is morbidly obese (BMI > 41); The patient has a deformity which will require the use of stems, wedges or augments; The patient has a varus deformity ≥ 15°; The patient has a valgus deformity >3°; The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device; The patient is unable to speak German; The patient is pregnant.

ClinicalTrials.gov NCT06280352