About this trial
Title: Personalized Total Knee Arthroplasty: Computer-Assisted Navigation vs. Robotic Assistance (CAN-ARD).
Summary:
Knee osteoarthritis is frequently treated with Total Knee Arthroplasty (TKA). However, approximately 20% of patients remain dissatisfied following the procedure. This study aims to compare two surgical assistance technologies designed to improve prosthetic placement accuracy: Computer-Assisted Navigation (CAN) and Robotic-Arm Assistance (RA).
The primary objective is to determine if there is a significant difference in functional outcomes and the "forgotten joint" sensation (measured by the Forgotten Joint Score - FJS) between patients operated on with robotic assistance versus those with traditional navigation at 3, 12, and 24 months post-surgery. The study's hypothesis is that there is no major clinical difference between these two techniques when applied within a personalized alignment strategy.
Eligibility criteria
Qualifiers
Patient providing written informed consent according to regulatory requirements
Male or female patients aged ≥18 years
Patients undergoing primary total knee arthroplasty for osteoarthritis
Use of Attune® prosthesis with posterior cruciate ligament retention (CR) and patellar resurfacing
Disqualifiers
History of ligament reconstruction
Previous fracture or bone surgery (osteotomy) of the ipsilateral femur or tibia (except hip or ankle surgery)
Preoperative knee stiffness with flexion contracture >15° or flexion <90°
Individuals deprived of liberty by judicial or administrative decision
Trial design
Treatments tested in this trial
- Robotic-Arm Assisted Surgery (RA)
- Computer-Assisted Navigation (CAN)
Treatment groups
Locations
1Sponsors and collaborators
Groupe Hospitalier Diaconesses Croix Saint-Simon
Lead sponsor