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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Difference in Medial Proximal Tibial Angle (MPTA) between CT scan and Imageless Navigation.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Non-image-based Computer-Assisted Navigation with Bone Morphing (Procedure)
结局指标
主要结局
Mean Difference in Medial Proximal Tibial Angle (MPTA) between CT scan and Imageless Navigation.
时间窗: 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.
次要结局
- Mean Difference in Lateral Distal Femoral Angle (LDFA) between CT scan and Imageless Navigation.(At the time of surgery (intraoperative))
- Correlation of MPTA and LDFA measurements before and after cartilage removal.(At the time of surgery (intra-operative).)