Clinical efficacy and effectiveness of 3D printing: a systematic review

Abstract

ObjectiveTo evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.DesignSystematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.Data sourcesPubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.MethodsA 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.ResultsOf 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.ConclusionsAll 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.

Fabrication of Muco-Adhesive Oral Films by the 3D Printing of Hydroxypropyl Methylcellulose-Based Catechin-Loaded Formulations

“…1,2) Rapid prototyping is a common use of 3D printing to develop approaches for efficiently designing and manufacturing parts such as jigs and entire devices. Various medical devices 3,4) and imaging phantoms 5) have been produced using 3D printers. 3D printing of a surgical site is useful for understanding the pathology of the site before surgery and for aiding patient understanding of their condition prior to giving consent for surgery.…”

Rapid Fabrication of Anatomically-Shaped Bone Scaffolds Using Indirect 3D Printing and Perfusion Techniques

“…Other polymers without acid release and the release profiles of calcium and phosphorus ions from the scaffold should be investigated. Translation of this 3D P&P technology into the clinical realm, like any other translational tissue engineering technologies, must consider manufacturing, regulatory compliance, hospital procurement, and reimbursement [43,44].…”

<p>The Personalized Shoulder Reconstruction Assisted by 3D Printing Technology After Resection of the Proximal Humerus Tumours</p>

“…3D printing technology, also referred to additive manufacturing, has gained great attention in the medical field because of its potential benefits. 32,33 First, 3D-printed realsized models can give the surgeons better visualization and understanding of tumour anatomy. 20,34 Riggs et al 34 reported that they successfully printed a physical 3D-printed model to gain a better understanding of the complex cardiac structures as well as spatial relationship and extent of the tumour before surgery, so as to maximize the removal of the tumour while avoiding damage to critical structures.…”