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Is It Possible to Obtain Reliable MPTA and LDFA Values Using Imageless Navigation in Total Knee Arthroplasty? Comparison Between Preoperative CT Scan Measurements and Intraoperative Bone Morphing Before and After Articular Cartilage Removal (CAR-NAV-AL)

Is It Possible to Obtain Reliable MPTA and LDFA Values Using Imageless Navigation in Total Knee Arthroplasty? Comparison Between Preoperative CT Scan Measurements and Intraoperative Bone Morphing Before and After Articular Cartilage Removal.

Title: Evaluation of Image-less Navigation Accuracy in Total Knee Arthroplasty (CARNAVAL)

Summary:

The purpose of this study is to evaluate the accuracy of an imageless navigation system in measuring key anatomical angles (MPTA and LDFA) during Total Knee Arthroplasty (TKA). While preoperative CT scans are currently the gold standard for bone planning, imageless navigation uses a "bone morphing" technique during surgery to create a digital model of the knee.

The study aims to determine if the measurements obtained via bone morphing, both before and after cartilage removal, are consistent with the measurements obtained from preoperative CT scans. The investigators seek to confirm if imageless navigation can provide reliable anatomical data, potentially reducing the need for preoperative radiation and costs associated with CT imaging.

研究概览

详细说明

Background:

Accurate alignment is critical for the long-term success of Total Knee Arthroplasty (TKA). Newer robotic and navigated systems rely on bone morphing to define the patient's anatomy per-operatively. However, the impact of cartilage thickness and the intrinsic accuracy of these systems compared to 3D CT-based planning remain subjects of clinical interest.

Objectives:

The primary objective is to compare the Medial Proximal Tibial Angle (MPTA) and the Lateral Distal Femoral Angle (LDFA) measured by:

Preoperative CT scan (Reference standard).

Peroperative image-less navigation (bone morphing) with intact cartilage.

Peroperative image-less navigation (bone morphing) after cartilage removal.

Methodology:

This is a prospective, monocentric, interventional study. All included patients will undergo a standard preoperative 3D CT scan as part of the surgical planning. During the TKA procedure, the surgeon will use the navigation system to perform bone morphing at two specific stages:

Initial stage: On the joint surface with the cartilage still present.

Secondary stage: After the surgical removal of the articular cartilage.

Comparison:

The data collected peroperatively will be compared to the CT scan measurements. The study will evaluate the "fidelity" (accuracy) of the navigation system and analyze whether the presence or absence of cartilage significantly alters the reliability of the digital bone model created by the system.

Expected Outcomes:

The results will help determine the degree of confidence surgeons can place in imageless navigation for achieving precise anatomical alignment without the systematic use of preoperative 3D imaging.

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Paris、法国、75020
        • Groupe Hospitalier Diaconesses Croix Saint Simon

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Patients aged 18 years or older.

Patients with primary or secondary knee osteoarthritis requiring a Total Knee Arthroplasty (TKA).

Patients for whom the surgical planning requires a pre-operative 3D CT scan.

Patients who have been informed about the study and have signed the written informed consent.

Patients affiliated with or beneficiaries of a social security scheme.

Exclusion Criteria:

Revision Total Knee Arthroplasty (re-operation).

Major bone loss or significant bone deformity that prevents reliable anatomical landmarking.

History of prior knee surgery that could interfere with the navigation system trackers (e.g., retained hardware in the femur or tibia).

Pregnant or breastfeeding women.

Persons deprived of liberty or under legal guardianship.

Patients with a known allergy to any component used during the standard surgical procedure.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Navigation and CT-scan Comparison Group)
All participants undergo Total Knee Arthroplasty (TKA) using an imageless navigation system. Anatomical measurements (MPTA and LDFA) are recorded via bone morphing at two stages: 1) on intact articular cartilage and 2) after cartilage removal.
Intraoperative surface morphing of the joint surfaces is performed to obtain LDFA and MPTA values. The procedure compares measurements taken on the residual cartilage versus measurements taken directly on the osseous surface after cartilage debridement. These values are then validated against preoperative 3D CT scan data.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean Difference in Medial Proximal Tibial Angle (MPTA) between CT scan and Imageless Navigation.
大体时间:At the time of surgery (intra-operative).
The mean difference (measured in degrees) between the MPTA calculated from the preoperative 3D CT scan and the MPTA measured intraoperatively via bone morphing after cartilage removal.
At the time of surgery (intra-operative).

次要结果测量

结果测量
措施说明
大体时间
Mean Difference in Lateral Distal Femoral Angle (LDFA) between CT scan and Imageless Navigation.
大体时间:At the time of surgery (intraoperative)
The mean difference (measured in degrees) between the LDFA calculated from the preoperative 3D CT scan and the LDFA measured intraoperatively via bone morphing after cartilage removal.
At the time of surgery (intraoperative)
Correlation of MPTA and LDFA measurements before and after cartilage removal.
大体时间:At the time of surgery (intra-operative).
Evaluation of the measurement shift (in degrees) caused by the presence of articular cartilage during the bone morphing process. This assesses the system's ability to extrapolate the subchondral bone surface.
At the time of surgery (intra-operative).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Antoine MOUTON, Orthopedic surgeon、Diaconesses Croix Saint Simon Hospital Group

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年7月7日

初级完成 (实际的)

2025年10月30日

研究完成 (实际的)

2025年10月30日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月14日

上次提交的符合 QC 标准的更新

2026年5月11日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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