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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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
AUVA UKH Steiermark Standort Graz
Graz, Styria, Austria
RECRUITINGAUVA UKH Steiermark Standort Kalwang
Kalwang, Styria, Austria
RECRUITINGClinical Outcome using the Forgotten Joint Score
Scale 0-100, higher score means better outcome
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Clinical outcomes using the Kujala anterior knee pain Score
Scale 0-100, higher score means better outcome
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Patient satisfaction
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
Visual analog pain (VAS) scale
Scale 0-10, higher score means better outcome
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Surgical and total theatre time
Time frame: Perioperative phase
Opioid use
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
Number of physiotherapy sessions
Time frame: Intraoperative stay
Range of motion measurements (in degrees)
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Measurement using a manual goniometer.
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic data including radiolucent lines
Incidence of radiolucent lines \>1 mm, with zones defined according to the New Knee Society Classification
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Revision rate
Time frame: Minimum 2 years