Lazzeri Simone, Talanti Emiliano, Basciano Simone, Barbato Raffaele, Fontanelli Federico, Uccheddu Francesca, Servi Michaela, Volpe Yary, Vagnoli Laura, Amore Elena, Marzola Antonio, McGreevy Kathleen S, Carfagni Monica
Meyer Children's Hospital, Viale Gaetano Pieraccini, 24, 50139 Florence, Italy.
Department of Industrial Engineering, University of Florence, Via Santa Marta 3, 50139 Florence, Italy.
Materials (Basel). 2022 Apr 13;15(8):2863. doi: 10.3390/ma15082863.
Orthopaedic and Trauma surgery is expected to undergo profound transformation as a result of the adoption of 3D technology. Among the various applications, patient specific manufacturing of splints and casts would appear to be, particularly in children, an interesting implementation. This study aims to assess the safety of patient specific 3D casts obtained with a newly developed 3D-scanning devise in a small case series. We therefore conducted a clinical outcome and pre-marketing study in 10 consecutive patients with distal radius fractures treated at an Academic Level I Pediatric Trauma Center. After the application of the 3D cast, patients underwent three consecutive evaluations in the following 21 days. The main outcome measurements were: pain, skin lesions and general comfort, and acceptance of the cast. The three domains were measured with the Visual Analogue Scale (VAS), the NPUAP/EPUAP classification and the Positive affect-Negative affect Scale for Children (PANAS-C), the Self-Assessment Manikin (SAM) clinical psychology tests and a Likert-type five item questionnaire, respectively. A final mechanical analysis of the cast was carried out to confirm product integrity.
The results obtained were consistently positive in the investigated domains of general comfort, efficacy of contention and mechanical integrity of the 3D-printed cast as well as in the practicability of the supply chain.
This study provides Level IV evidence that patient specific 3D printed casts obtained with a specifically designed software were safe in the management of "buckle" fractures of the distal radius in children. These results encourage to extend the technology to the treatment of more demanding fractures.
由于3D技术的应用，骨科和创伤外科手术预计将经历深刻变革。在各种应用中，针对患者定制夹板和石膏模型，尤其是针对儿童患者，似乎是一个有趣的应用方向。本研究旨在通过一个小病例系列评估使用新开发的3D扫描设备获得的针对患者定制的3D石膏模型的安全性。因此，我们在一家一级学术儿科创伤中心对10例连续的桡骨远端骨折患者进行了一项临床结果和上市前研究。在应用3D石膏模型后，患者在接下来的21天内接受了连续三次评估。主要结局指标为：疼痛、皮肤损伤和总体舒适度，以及对石膏模型的接受度。这三个领域分别通过视觉模拟量表（VAS）、NPUAP/EPUAP分类、儿童积极情感-消极情感量表（PANAS-C）、自我评估人体模型（SAM）临床心理学测试和一个李克特式五项问卷进行测量。对石膏模型进行了最终的力学分析以确认产品完整性。
在所研究的总体舒适度、3D打印石膏模型的固定效果和力学完整性以及供应链实用性等领域，所获得的结果始终呈阳性。
本研究提供了四级证据，表明使用专门设计的软件获得的针对患者定制的3D打印石膏模型在儿童桡骨远端“青枝”骨折的治疗中是安全的。这些结果鼓励将该技术扩展到治疗更复杂的骨折。
