Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon

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

140 Participants
are divided into 2 treatment groups

Locations

1
Groupe hospitalier Diaconesses Croix Saint Simon75020, ParisParis, France

Sponsors and collaborators

Groupe Hospitalier Diaconesses Croix Saint-Simon

Lead sponsor