Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery (CAN-ARD)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Younes KERROUMI, Clinical Research Physician
- Número de teléfono: +33144643384
- Correo electrónico: ykerroumi@hopital-dcss.org
Ubicaciones de estudio
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Paris
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Paris, Paris, Francia, 75020
- Reclutamiento
- Groupe Hospitalier Diaconesses Croix Saint Simon
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Robotic
Patients undergoing Prosthetic knee arthroplasty under robotic assistance
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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.
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Comparador activo: Navigation
Patients undergoing Prosthetic knee arthroplasty under navigation assistance
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Forgotten Joint Score (FJS).
Periodo de tiempo: 3, 12, and 24 months postoperatively.
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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)
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3, 12, and 24 months postoperatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee Injury and Osteoarthritis Outcome Score (KOOS).
Periodo de tiempo: 3, 12, and 24 months postoperatively.
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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.
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3, 12, and 24 months postoperatively.
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Self Knee Value (SKV).
Periodo de tiempo: 3, 12, and 24 months postoperatively.
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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.
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3, 12, and 24 months postoperatively.
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Net Promoter Score (NPS)
Periodo de tiempo: 3, 12, and 24 months postoperatively.
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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
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3, 12, and 24 months postoperatively.
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Active Range of Motion.
Periodo de tiempo: Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
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Measurement of the active flexibility (extension and flexion) of the operated knee using a goniometer.
Measured in degrees
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Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
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Operative Time
Periodo de tiempo: During the surgical procedure (Day 0).
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Total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
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During the surgical procedure (Day 0).
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Incidence of Surgical and Postoperative Adverse Events.
Periodo de tiempo: Through 24 months postoperatively.
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Documentation of complications including:Intraoperative: Technology-related issues or interruption of surgical assistance.
Postoperative: Revision surgery, manipulation under anesthesia, or implant loosening.
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Through 24 months postoperatively.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Clark TC, Schmidt FH. Robot-Assisted Navigation versus Computer-Assisted Navigation in Primary Total Knee Arthroplasty: Efficiency and Accuracy. ISRN Orthop. 2013 Jun 24;2013:794827. doi: 10.1155/2013/794827. eCollection 2013.
- Geng X, Zheng Y, Li Y, Zhao M, Liu Y, Li Z, Cai H, Zhang M, Yan X, Sun Z, Lv X, Guo F, Li F, Tian H. Early Radiographic and Clinical Outcomes of Robotic-arm-assisted versus Conventional Total Knee Arthroplasty: A Multicenter Randomized Controlled Trial. Orthop Surg. 2024 Nov;16(11):2732-2740. doi: 10.1111/os.14196. Epub 2024 Aug 12.
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-A00665-44
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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