Custom made Total Knee Arthroplasty
DeviceTotal knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
NCT Number: NCT06280352
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.
Interested in participating?
Request Info40 year–90 year
All sexes
Interventional
Not applicable
AUVA UKH Steiermark Standort Graz, Graz, Styria, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Scale 0-100, higher score means better outcome
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Scale 0-100, higher score means better outcome
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Question "Are you satisfied with the outcome of your operation" using a Likert scale with 5 points: 1- very dissatisfied, 2-dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Scale 0-10, higher score means better outcome
Time frame: Perioperative phase
Time frame: Intraoperative stay
Total dosage of opioids, registered in Austria for pain management after knee replacement, administered to the patient during in-hospital stay: Hydromorphon, Tramadol, Oxycodone/Naloxon as well as number of ampules of Piritramid
Time frame: Intraoperative stay
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Measurement using a manual goniometer.
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Incidence of radiolucent lines >1 mm, with zones defined according to the New Knee Society Classification
Time frame: Minimum 2 years
Contact information is provided by the study sponsor or research team.
Austrian Workers Compensation Board Styria
Other
Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty
Acronym: Knieathlon
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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