Luo Dinghao, Wu Junxiang, Ran Zhaoyang, Wu Wen, Wang Lei, Xie Kai, Hao Yongqiang
Department of Orthopedics, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai Key Laboratory of Orthopedic Prostheses, Shanghai, China.
Front Bioeng Biotechnol. 2025 Aug 18;13:1604285. doi: 10.3389/fbioe.2025.1604285. eCollection 2025.
Screw fixation is pivotal for prosthetic stability. For 3D-printed customized acetabular revision prostheses designed for complex, large-scale bone defects, precise adherence to preoperative screw trajectory planning is critical. However, there remains a lack of standardized three-dimensional (3D) evaluation protocols to quantify intraoperative screw angular alignment fidelity relative to preoperative digital plans, hindering universal validation criteria.
A total of 11 patients were stratified into two groups based on postoperative Harris Hip Scores and severe complication rates: the better outcome group and the regular outcome group. A 3D pelvic coordinate system was established using anatomical landmarks. Two biomechanically critical screws per prosthesis were selected to quantify 3D angular deviations between postoperative and preoperative plans. The efficacy of this method was compared with simulated anteroposterior radiograph-based 2D measurements. Inter- and intra-observer consistency (kappa statistics) were evaluated to assess reproducibility.
High inter-observer (κ = 0.88) and intra-observer (κ = 0.87, 0.75) agreement confirmed method reliability. While individual critical screw deviations showed no significant intergroup differences, the cumulative angular deviation of critical screws was significantly lower in the better outcome group (p = 0.0147). In contrast, 2D radiographic analysis failed to distinguish intergroup differences in cumulative deviations (p = 0.1489), demonstrating reduced clinical relevance.
This 3D assessment protocol robustly correlates with clinical outcomes, providing a validated tool for evaluating preoperative-to-postoperative fidelity in customized acetabular revision prostheses. To our knowledge, this is the first CT-based 3D coordinate system study quantifying critical screw alignment accuracy in patient-specific prostheses, with clinical validation.
螺钉固定对假体稳定性至关重要。对于为复杂、大规模骨缺损设计的3D打印定制髋臼翻修假体,精确遵循术前螺钉轨迹规划至关重要。然而,目前仍缺乏标准化的三维(3D)评估方案来量化术中螺钉角度对准与术前数字计划的保真度,这阻碍了通用验证标准的建立。
根据术后Harris髋关节评分和严重并发症发生率,将11例患者分为两组:较好结果组和常规结果组。利用解剖标志建立3D骨盆坐标系。每个假体选择两根生物力学关键螺钉,以量化术后和术前计划之间的3D角度偏差。将该方法的有效性与基于模拟前后位X线片的二维测量进行比较。评估观察者间和观察者内的一致性(kappa统计量)以评估可重复性。
观察者间(κ = 0.88)和观察者内(κ = 0.87, 0.75)的高度一致性证实了该方法的可靠性。虽然单个关键螺钉偏差在组间无显著差异,但较好结果组关键螺钉的累积角度偏差显著更低(p = 0.0147)。相比之下,二维X线分析未能区分组间累积偏差的差异(p = 0.1489),表明其临床相关性降低。
这种3D评估方案与临床结果密切相关,为评估定制髋臼翻修假体术前到术后的保真度提供了一种经过验证的工具。据我们所知,这是第一项基于CT的3D坐标系研究,对患者特异性假体中的关键螺钉对准精度进行量化,并进行了临床验证。