Purpose: Although high costs are often cited as the main limitation of 3D printing (3DP) in the medical field, current lack of clinical evidence is asserting itself as an impost as the field begins to mature. The aim is to review clinical trials in the field of 3DP, an area of research which has grown dramatically in recent years.
Methods: We surveyed clinical trials registered in 15 primary registries worldwide, including ClinicalTrials.gov. All trials which utilized 3DP in a clinical setting were included in this review. Our search was performed on December 15, 2017. Data regarding the purpose of the study, inclusion criteria, number of patients enrolled, primary outcomes, centers, start and estimated completion dates were extracted.
Results: A total of 92 clinical trials with [Formula: see text]252 patients matched the criteria and were included in the study. A total of 42 (45.65%) studies cited China as their location. Only 10 trials were multicenter and 2 were registered as international. The discipline that most commonly utilized 3DP was Orthopedic Surgery, with 25 (27.17%) registered trials. At the time of data extraction, 17 (18.48%) clinical trials were complete.
Conclusions: After several years of case reports, feasibility studies and technical reports in the field, larger-scale studies are beginning to emerge. There are almost no international register entries. Although there are new emerging areas of study in disciplines that may benefit from 3DP, it is likely to remain limited to very specific applications.
Keywords: 3D printing; Anatomical models; Clinical trials; Preoperative planning; Review.