Efficacy and safety of 3D print-assisted surgery for the treatment of pilon fractures: a meta-analysis of randomized controlled trials

Abstract

ObjectiveTo compare the effects of 3D print-assisted surgery and conventional surgery in the treatment of pilon fractures.MethodsPubMed, Embase, Web of Science, CNKI, CBM, and WanFang data were searched until July 2018. Two reviewers selected relevant studies, assessed the quality of studies, and extracted data. For continuous data, a weighted mean difference (WMD) and 95% confidence intervals (CI) were used. For dichotomous data, a relative risk (RR) and 95% CI were calculated as the summary statistics.ResultsThere were seven randomized controlled trials (RCT) enrolling a total of 486 patients, 242 patients underwent 3D print-assisted surgery and 244 patients underwent conventional surgery. The pooled outcomes demonstrate 3D print-assisted surgery was superior to conventional surgery in terms of operation time [WMD = − 26.16, 95% CI (− 33.19, − 19.14), P < 0.001], blood loss [WMD = − 63.91, 95% CI (− 79.55, − 48.27), P < 0.001], postoperative functional scores [WMD = 8.16, 95% CI (5.04, 11.29), P < 0.001], postoperative visual analogue score (VAS) [WMD = − 0.59, 95% CI (− 1.18, − 0.01), P = 0.05], rate of excellent and good outcome [RR = 1.20, 95% CI (1.07, 1.34), P = 0.002], and rate of anatomic reduction [RR = 1.35, 95% CI (1.19, 1.53), P < 0.001]. However, there was no significant difference between the groups regarding the rate of infection [RR = 0.51, 95% CI (0.20, 1.31), P = 0.16], fracture union time [WMD = − 0.85, 95% CI (− 1.79, 0.08), P = 0.07], traumatic arthritis [RR = 0.34, 95% CI (0.06, 2.09), P = 0.24], and malunion [RR = 0.34, 95% CI (0.06, 2.05), P = 0.24].ConclusionsOur meta-analysis demonstrates 3D print-assisted surgery was significantly better than conventional surgery in terms of operation time, blood loss, postoperative functional score, postoperative VAS, rate of excellent and good outcome, and rate of anatomic reduction. Concerning postoperative complications, there were no significant differences between the groups.

A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively

“…We have designed and manufactured a large number of 3D printouts with their intra-operative application ranging from models for plate contouring to corrective osteotomy guides and jigs for screw placement. With printouts in direct contact with patient tissues, it is important that we are able to assess for the risk of infection [6]. The overall infection rate of 7% was comparable to figures in the literature using traditional surgical techniques.…”

“…With regards to the benefits of 3D modelling on surgical execution, a meta-analysis compiling studies for pilon fracture management reported that operation time, blood loss, post-operative pain scores, achievement of anatomical fracture reduction, and post-operative function were all improved in comparison to conventional planning [6]. Rates of infection following 3D modelling amongst this cohort were not increased, and have been reported elsewhere to be as high as 16.1% owing to the degree of associated soft tissue trauma, with an average presentation time of 88-days post-op [15].…”

“…A total of 300 models have been rendered over the past four years, with 114 cases confirmed to have been utilized intra-operatively. For such cases, it is not reported in the literature whether terminal sterilization by means of hydrogen peroxide gas plasma is sufficient in preventing infection [6]. Here, we review details for cases requiring the application of 3D models and guides intra-operatively, identify cases subsequently developing surgical site infection, and identify risk factors for infection.…”

The role of a 3D printed model in the teaching of human anatomy: a meta-analysis

“…Diment [13] used a descriptive-analytical method to analyze the application of 3D printing models in clinical elds and proposed that 3D models have effective applications. Bai et al [12] reported in their meta-analysis that 3D print-assisted surgery was better than a conventional surgery in terms of the operation time, blood loss, and good outcome.…”

“…The applications of 3D printed models have been investigated in many meta-analyses [12][13][14][15]. These meta-analyses were mainly used in the eld of surgery.…”