Department of Engineering Science, University of Oxford, Oxford, UK.
BMJ Open. 2017 Dec 21;7(12):e016891. doi: 10.1136/bmjopen-2017-016891.
To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.
Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.
A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study.
Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy.
All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice.
评估在所有医学领域使用 3D 打印开发医疗设备的临床疗效和效果。
符合系统评价和荟萃分析首选报告项目的系统评价。
PubMed、Web of Science、OVID、IEEE Xplore 和 Google Scholar。
采用双盲审查方法，选择截至 2017 年 1 月所有报告三维（3D）打印医疗器械临床试验的摘要。根据证据水平对研究进行排名，根据国际疾病分类章节划分将研究分为医学领域，并分为用于术前规划、辅助手术或治疗的研究。采用唐斯和布莱克质量指数批判性评估工具评估每个研究的报告质量、外部有效性、偏倚风险、混杂风险和效能。
在筛选出的 3084 篇摘要中，有 350 篇符合纳入标准。口腔颌面外科的研究占 58.3%，肌肉骨骼系统的研究占 23.7%。仅有 21 项研究为随机对照试验（RCT），且均属于这两个领域。大多数 RCT 是用于术前规划和辅助手术的 3D 打印解剖模型。这些设备的主要优势在于减少手术操作时间和提高手术准确性。
所有评估 3D 打印设备的医学领域均认为其具有临床效果。最严格评估 3D 打印设备的领域是口腔颌面外科和肌肉骨骼系统，两者均认为 3D 打印设备优于传统对照物。然而，3D 打印设备在大多数医学领域的疗效和效果仍不确定。3D 打印设备在医疗保健中可以发挥重要作用，但需要进行更严格和长期的评估，以确定 3D 打印设备是否在成为标准临床实践的一部分之前具有临床相关性。
