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.

Background and Rationale:

Personalized alignment in total knee arthroplasty combines the restoration of the patient's unique anatomy (restricted kinematic alignment) with joint stability. While computer-assisted navigation has been successfully used since 2003 to plan and control implant positioning, robotic assistance is gaining popularity due to its ability to perform more precise bone cuts using a haptic robotic arm. This study seeks to investigate whether this technical gain in precision translates into a real clinical benefit for the patient in terms of satisfaction and joint perception.

Study Design:

This is an interventional, prospective, randomized, single-center study. A total of 140 patients (70 per group) will be enrolled.

Interventions:

Participants will be randomly assigned to one of the following two arms:

Navigation Group: TKA implantation (Attune® CR) guided by an intraoperative computer navigation system.

Robotic Group: TKA implantation using a robotic-arm-assisted system (a motorized saw linked to the navigation software).

Follow-up and Evaluations:

Patients will be followed for 24 months. Evaluations will include:

Primary Endpoint: Forgotten Joint Score (FJS) at 3, 12, and 24 months.

Secondary Endpoints: Satisfaction and functional scores (KOOS, SKV, Net Promoter Score), range of motion measurements, operative time, and monitoring of any complications.

Target Population:

Adults (≥ 18 years) scheduled for primary total knee arthroplasty for osteoarthritis, with no history of major bone surgery on the affected limb.

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

Model Type: Parallel Assignment. Number of Arms: 2 arms (Navigation vs. Robotic). Allocation: Randomized. Masking: Single Blind (Outcomes Assessor). While the surgeon cannot be blinded to the technology used during the procedure, the functional outcomes and scores (FJS, KOOS, SKV) are typically assessed in a way to minimize bias, and the protocol notes a rigorous randomization procedure to ensure impartiality.