Total Knee Replacement With Personalized Implantation Navigation-assisted Surgery Versus Robotic Assistance "CAN-ARD"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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