Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery
Recruiting · NCT07574762 · Interventional (participants receive a specific treatment) · Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- Patients not affiliated with a social security system
- Patients unable to understand French
- Patients with cognitive impairment
- Patients whose place of residence makes close clinical follow-up impossible -- Women of childbearing potential without effective contraception
- Pregnant or breastfeeding women
Where it is running
1 location listed.
- Groupe hospitalier Diaconesses Croix Saint Simon - Paris, Paris, France