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Patient-centred medicine
Research
Clinical efficacy and effectiveness of 3D printing: a systematic review
  1. Laura E Diment,
  2. Mark S Thompson,
  3. Jeroen H M Bergmann
  1. Department of Engineering Science, University of Oxford, Oxford, UK
  1. Correspondence to Dr Jeroen H M Bergmann; jeroen.bergmann{at}eng.ox.ac.uk

Abstract

Objective To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.

Design Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Data sources PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.

Methods 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.

Results 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.

Conclusions 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.

  • printing, three-dimensional
  • health care evaluation mechanisms
  • medical devices
  • personalised healthcare
  • fabrication
  • additive manufacturing

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-016891

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    Footnotes

    • Contributors LED, JHMB and MST designed the review. LED and JHMB collected and analysed the data with input from MST. LED drafted the manuscript. All authors contributed to subsequent drafts and approved the final version of the manuscript.

    • Funding The researchers are financially supported by the General Sir John Monash Foundation and the Wellcome Trust (103383/B/13/Z).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All additional data are available in the supplementary material.