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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Forgotten Joint Score (FJS). [Срок оценки: 3, 12, and 24 months postoperatively.]

Вторичные конечные точки (6)

• Knee Injury and Osteoarthritis Outcome Score (KOOS). [Срок оценки: 3, 12, and 24 months postoperatively.]
• Self Knee Value (SKV). [Срок оценки: 3, 12, and 24 months postoperatively.]
• Net Promoter Score (NPS) [Срок оценки: 3, 12, and 24 months postoperatively.]
• Active Range of Motion. [Срок оценки: Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.]
• Operative Time [Срок оценки: During the surgical procedure (Day 0).]
• Incidence of Surgical and Postoperative Adverse Events. [Срок оценки: Through 24 months postoperatively.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Groupe hospitalier Diaconesses Croix Saint Simon — Paris

Публикации

• 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. PMID 24967115
• 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. PMID 39135273

Идентификаторы

NCT: NCT07574762 · 2025-A00665-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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