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RECRUITING
NCT07574762
NA

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

Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

View on ClinicalTrials.gov

Summary

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.

Official title: Total Knee Replacement With Personalized Implantation Navigation-assisted Surgery Versus Robotic Assistance "CAN-ARD"

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-01-26

Completion Date

2029-01-26

Last Updated

2026-05-08

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Robotic-Arm Assisted Surgery (RA)

Total Knee Arthroplasty (TKA) performed using a robotic-arm-assisted system connected to navigation software. Like the navigation group, this arm utilizes the personalized alignment strategy and the Attune® CR prosthesis. Instead of manual cutting guides, the surgeon manipulates a robotic arm equipped with a motorized saw to perform the bone cuts according to the pre-planned digital model. This technology is intended to increase the precision of bone resections.

DEVICE

Computer-Assisted Navigation (CAN)

Total Knee Arthroplasty (TKA) performed using an intraoperative computer navigation system. The procedure follows a personalized alignment strategy (restricted kinematic alignment combined with joint stability). After creating a digital model of the knee and mapping anatomical landmarks, the navigation system assists the surgeon in manually positioning the bone cutting guides. The primary implant used is the Attune® CR (Cruciate-Retaining) prosthesis with patellar resurfacing.

Locations (1)

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, Paris, France