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Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery (CAN-ARD)

5 mai 2026 mis à jour par: Groupe Hospitalier Diaconesses Croix Saint-Simon

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

140

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
    • Paris
      • Paris, Paris, France, 75020
        • Recrutement
        • Groupe Hospitalier Diaconesses Croix Saint Simon

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Robotic
Patients undergoing Prosthetic knee arthroplasty under robotic assistance
Dispositif: 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.
Comparateur actif: Navigation
Patients undergoing Prosthetic knee arthroplasty under navigation assistance
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Forgotten Joint Score (FJS).
Délai: 3, 12, and 24 months postoperatively.
Assessment of the patient's ability to forget the artificial joint in daily life. Minimum score: 0, Maximum score: 100. A higher score indicates a better outcome (the patient is less aware of the prosthetic joint)
3, 12, and 24 months postoperatively.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Délai: 3, 12, and 24 months postoperatively.
Evaluation of the patient's opinion about their knee and associated problems. Minimum score: 0, Maximum score: 100. A higher score represents a better outcome.
3, 12, and 24 months postoperatively.
Self Knee Value (SKV).
Délai: 3, 12, and 24 months postoperatively.
Patient's subjective assessment of their knee as a percentage of a normal knee. Scale: 0% to 100%. A higher percentage represents a better outcome.
3, 12, and 24 months postoperatively.
Net Promoter Score (NPS)
Délai: 3, 12, and 24 months postoperatively.
A single-question survey used to measure patient satisfaction and their willingness to recommend the surgical procedure to others. The score is calculated based on responses to a single question on a scale of 0 to 10 (where 0 is "not at all likely" and 10 is "extremely likely"). Respondents are grouped as Promoters (9-10), Passives (7-8), or Detractors (0-6). The final NPS is calculated by subtracting the percentage of Detractors from the percentage of Promoters, resulting in a score ranging from -100 to +100. A higher score indicates higher patient satisfaction
3, 12, and 24 months postoperatively.
Active Range of Motion.
Délai: Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
Measurement of the active flexibility (extension and flexion) of the operated knee using a goniometer. Measured in degrees
Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
Operative Time
Délai: During the surgical procedure (Day 0).
Total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
During the surgical procedure (Day 0).
Incidence of Surgical and Postoperative Adverse Events.
Délai: Through 24 months postoperatively.
Documentation of complications including:Intraoperative: Technology-related issues or interruption of surgical assistance. Postoperative: Revision surgery, manipulation under anesthesia, or implant loosening.
Through 24 months postoperatively.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Groupe Hospitalier Diaconesses Croix Saint-Simon

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 janvier 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

26 janvier 2029

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

5 mai 2026

Première publication (Réel)

8 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2025-A00665-44

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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