Three-dimensional printing in orthopaedic surgery: a scoping review

in EFORT Open Reviews
Authors:
Jasmine N. LevesqueMichael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada

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Ajay ShahMichael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada

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Seper EkhtiariDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada

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James R. YanDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada

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Patrick ThornleyDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada

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Dale S. WilliamsDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada

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Seper Ekhtiari, Division of Orthopaedic Surgery, McMaster University, 5N-237 Barton St E Hamilton, Ontario, L8L 2X2, Canada. Email: seper.ekhtiari@medportal.ca
Open access

  • Three-dimensional printing (3DP) has become more frequently used in surgical specialties in recent years. These uses include pre-operative planning, patient-specific instrumentation (PSI), and patient-specific implant production.

  • The purpose of this review was to understand the current uses of 3DP in orthopaedic surgery, the geographical and temporal trends of its use, and its impact on peri-operative outcomes

  • One-hundred and eight studies (N = 2328) were included, published between 2012 and 2018, with over half based in China.

  • The most commonly used material was titanium.

  • Three-dimensional printing was most commonly reported in trauma (N = 41) and oncology (N = 22). Pre-operative planning was the most common use of 3DP (N = 63), followed by final implants (N = 32) and PSI (N = 22).

  • Take-home message: Overall, 3DP is becoming more common in orthopaedic surgery, with wide range of uses, particularly in complex cases. 3DP may also confer some important peri-operative benefits.

Cite this article: EFORT Open Rev 2020;5:430-441. DOI: 10.1302/2058-5241.5.190024

Abstract

  • Three-dimensional printing (3DP) has become more frequently used in surgical specialties in recent years. These uses include pre-operative planning, patient-specific instrumentation (PSI), and patient-specific implant production.

  • The purpose of this review was to understand the current uses of 3DP in orthopaedic surgery, the geographical and temporal trends of its use, and its impact on peri-operative outcomes

  • One-hundred and eight studies (N = 2328) were included, published between 2012 and 2018, with over half based in China.

  • The most commonly used material was titanium.

  • Three-dimensional printing was most commonly reported in trauma (N = 41) and oncology (N = 22). Pre-operative planning was the most common use of 3DP (N = 63), followed by final implants (N = 32) and PSI (N = 22).

  • Take-home message: Overall, 3DP is becoming more common in orthopaedic surgery, with wide range of uses, particularly in complex cases. 3DP may also confer some important peri-operative benefits.

Cite this article: EFORT Open Rev 2020;5:430-441. DOI: 10.1302/2058-5241.5.190024

Introduction

Three-dimensional (3D) printing is a process of design and manufacturing that was invented in the early 1980s. 1 Three-dimensional printing is considered a type of ‘additive manufacturing’, in that the final product is achieved by building up in layers of a given material. 2 This is in contrast to the more traditional subtractive manufacturing, in which elements are removed from a block of material to achieve the desired product (see Fig. 1). As the technology has matured, 3D printing has become easier to utilize, less expensive, and more readily available. 3 This has helped to expand its uses into many fields including manufacturing, art, industry, and medicine.

Fig. 1
Fig. 1

Conceptual representation of additive vs. subtractive manufacturing.

Source. Modified from the United States Government Accountability Office.

Citation: EFORT Open Reviews 5, 7; 10.1302/2058-5241.5.190024

Current medical applications of 3D printing include custom medication dosage delivery, 4,5 custom design and manufacturing of medical equipment, 6 and the creation of anatomic models. 7,8 Orthopaedic surgery, with its focus on implants, instruments, and surgical devices, is well suited to applications of 3D printing. Multiple studies have shown that the use of 3D-printed models based on real patient imaging improve the inter-rater reliability of complex acetabular fracture classification compared to the use of radiographs and cross-sectional imaging alone. 9,10 The use of 3D printing also has many clinical applications, including pre-operative planning, 1113 manufacturing of patient-specific instrumentation (PSI), 1416 and the manufacture of case-specific implants (e.g. plates and arthroplasty components). 1719 Overall, there is great potential to be able to provide patients with personalized implants and instrumentation that are created quickly and at low cost. 20

As would be expected with new applications of a relatively new technology, there has been a sharp increase in the amount of published literature presenting orthopaedic applications of 3D printing. In addition, a number of narrative reviews have provided an overview of the topic. 20,21 As well, there is a recent systematic review on the applications of 3D printing in spine surgery, which found that 3D printing allows for better implant properties, reduced operative time, and better patient outcomes. 22 Finally, a recent systematic review on the use of 3D printing in orthopaedic trauma demonstrated significant interest in and rapid growth of 3D printing in that subspecialty. To the authors’ knowledge, however, there does not exist a broad, up-to-date review of the clinical applications of 3D printing in the entire field of orthopaedic surgery. Thus, the objectives of the current review were to answer the following questions: (1) what are the current clinical uses of 3D printing in orthopaedic surgery?, and (2) what are the geographical and temporal trends in the use of 3D printing in orthopaedic surgery?, and (3) does the use of 3D printing in orthopaedic surgery have an impact on peri-operative outcome?

Materials and methods

This review was performed in large part in adherence to the Cochrane handbook for systematic reviews of interventions 23 and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). 24 This review was prospectively registered on PROSPERO (Registration ID: CRD42018099144). However, it was felt that, given the novelty of this technology, it would be useful and important to include all reported uses of 3D printing; thus the search and inclusion strategy are more broad than a traditional systematic review.

Search strategy

A search strategy was developed by two of the authors (SE and JRY) in collaboration with a health sciences research methodology librarian. Given that the use of 3D printing is a relatively new concept within the field of orthopaedic surgery, the search strategy was kept intentionally broad. The keywords used included “3D print*”, “three-dimensional print*”, and “surg*” (Appendix 1). Four databases (PubMed, Embase, MEDLINE, and Web of Science) were searched from the earliest available date up to and including 13 November 2018. Inclusion criteria were (1) clinical studies reporting on the peri-operative use of 3D printing in orthopaedic surgery. Exclusion criteria were (1) review articles, and (2) articles pertaining to surgical education.

Study screening

Two authors (JNL and AS) independently reviewed all of the titles, abstracts, and full texts, assessing agreement at each stage. Any discrepancies at the title and abstract stages were resolved by automatic inclusion. At the full text stage, disagreements were resolved by consensus. Where consensus could not be reached, a third, more senior author (SE) was consulted.

Quality assessment

The quality of included studies was assessed based on the type of study. Randomized controlled trials (RCTs) were assessed for risk of bias using the Cochrane Risk of Bias Assessment Tool. The Risk of Bias Assessment Tool assesses the likelihood of bias in RCTs across seven primary domains, rating each domain as having a ‘low’, ‘high’, or ‘unclear’ likelihood of demonstrating bias. 25 The Methodological Index for Non-Randomized Studies (MINORS) was used to assess the quality of non-randomized studies. The MINORS tool consists of a total of 12 questions applicable to comparative studies, eight of which are applicable to non-comparative studies. Each item is rated on a three-point scale from 0 to 2, for a maximum score of 16 for non-comparative studies and 24 for comparative studies. 26

Data abstraction

Data was abstracted by two authors (JNL and AS) into a Microsoft Excel (Version 16.12) spreadsheet designed a priori. The authors verified one another’s data abstraction using a random spot-check method. Data extracted included information on study type, location of study, type of 3D printing material used, cost of 3D printing, patient demographics, the specific application of 3D printing, and peri-operative outcomes.

Statistical analysis

Agreement for each stage of the screening process was calculated using a Kappa (κ) statistic, and the results were interpreted as follows: 0 = no agreement, 0–0.2 = slight agreement, 0.2–0.4 = fair agreement, 0.4–0.6 = moderate agreement, 0.6–0.8 = substantial agreement, and 0.8–1.0 = almost perfect agreement. 27 Descriptive statistics (frequencies, mean or median, and 95% confidence intervals, standard deviation, or interquartile ranges) were used to report study characteristics, basic demographic information, uses of 3D printing, and patient outcomes. Due to broad inclusion criteria and expected low quality of evidence overall, a meta-analysis was not planned. A qualitative assessment of peri-operative outcomes (estimated blood loss (EBL), operative time, and fluoroscopy use) was performed using high-quality (i.e. Level I and Level II) studies.

Results

Characteristics of included studies

The initial search of the online databases returned 5124 studies, of which 108 met the inclusion and exclusion criteria (Fig. 2). There was satisfactory agreement among reviewers at the title (κ = 0.777; 95% CI, 0.754 to 0.801), abstract (κ = 0.605; 95% CI, 0.543 to 0.667), and full-text (κ = 1.0; 95% CI, 1.000 to 1.000) stages.

Fig. 2
Fig. 2

PRISMA flow diagram.

Citation: EFORT Open Reviews 5, 7; 10.1302/2058-5241.5.190024

The 108 included studies were published between 2012 and 2018. There was a trend towards an increasing number of publications in more recent years, with 20 studies published from 2012–2015, and 88 studies published from 2016–2018 (Fig. 3). Of these studies, 42 were case reports, 39 case series, 16 cohort studies and 11 randomized controlled trials (Table 1). Over half of all included studies were conducted in China (N = 55, 50.9%), with the next highest numbers of studies coming from the United States (N = 12, 11.1%), followed by Australia and Spain (N = 5 each, 4.6%). Considering geographical regions, Asia produced the most studies (N = 66, 61.1%), followed by Europe (N = 22, 20.4%), and North America (N = 13, 12.0%).

Fig. 3
Fig. 3

Number of included studies by year.

Note. Data from 2018 does not include the full year as the search was performed in November 2018.

Citation: EFORT Open Reviews 5, 7; 10.1302/2058-5241.5.190024

Table 1.

Study demographics

Author

(reference numbers in Appendix 2)
Year Country Subspecialty Study type LOE N 3DP Patients % Female Mean age (years) MINORS score
Bagaria and Chaudhary1 2017 India Multiple Case series IV 50 50 NR NR 11/16
Beliën et al2 2017 Belgium Upper extremity Case series IV 5 5 20.0 49.0 9/16
Bizzotto et al3 2016 Italy Trauma Case series IV 40 40 NR NR 9/16
Bizzotto et al4 2016 Italy Trauma Case series IV 102 102 55.9 (20.0–78.0) 8/16
Cai et al5 2018 China Trauma Retrospective cohort study III 137 65 40.1 32.8 23/24
Chae et al6 2015 Australia Foot and ankle Case report IV 1 1 NR 82.0 4/16
Chana-Rodriguez et al7 2016 Spain Trauma Case report IV 1 1 NR 45.0 5/16
Chen et al8 2018 China Trauma Case series IV 48 16 33.3 52.4 15/24
Chen et al9 2016 China Oncology Case report IV 1 1 NR 62.0 10/16
Cherkasskiy et al10 2017 USA Pediatrics Retrospective cohort study III 15 5 53.3 13.5 20/24
Citak et al11 2016 Germany Arthroplasty/reconstructive Case report IV 1 1 100.0 61.0 6/16
Corona et al12 2018 Spain Foot and ankle Retrospective cohort study III 9 9 33.3 51.4 8/24
Dekker et al13 2018 USA Foot and ankle Case series IV 15 15 60.0 3.3 14/16
Dong et al14 2017 China Oncology Case report IV 1 1 0.0 65.0 9/16
Duan et al15 2018 China Foot and ankle Prospective cohort study II 29 15 48.0 55.0 15/24
Duncan et al16 2015 UK Trauma Case report IV 1 1 0.0 48.0 2/16
Fan et al17 2015 China Oncology Case series IV 3 3 100.0 37.3 14/16
Fang et al18 2015 China Trauma Case report IV 1 1 100.0 88.0 7/16
Fang et al19 2018 China Oncology Case report IV 1 1 100.0 43.0 9/16
Gemalmaz et al20 2017 Turkey Upper extremity Case report IV 1 1 0.0 18.0 11/16
Giannetti et al21 2016 Italy Trauma Prospective cohort study II 40 16 45.0 43.2 22/24
Giovinco et al22 2012 USA Foot and ankle Case report IV 1 1 NR NR 2/16
Hamada et al23 2017 Japan Upper extremity Case report IV 1 1 0.0 21.0 11/16
Hamid et al24 2016 USA Trauma Case report IV 1 1 100.0 46.0 9/16
Han et al24 2018 China Oncology Case report IV 1 1 100.0 32.0 9/16
Holt et al26 2017 USA Pediatrics Case report IV 1 1 100.0 10.0 10/16
Hsu and Ellington27 2015 USA Foot and ankle Case report IV 1 1 0.0 63.0 9/16
Hsu et al28 2018 China Trauma Retrospective cohort study III 29 12 13.8 37.6 17/24
Hughes et al29 2017 Ireland Arthroplasty/reconstructive Case series IV 2 2 NR NR 4/16
Hung et al30 2018 China Trauma Retrospective cohort study III 30 16 40.0 35.5 23/24
Imanishi and Choong31 2015 Australia Oncology Case report IV 1 1 0.0 71.0 8/16
Inge et al32 2018 Netherlands Upper extremity Case report IV 1 1 100.0 16.0 9/16
Jastifer and Gustafson33 2016 USA Foot and ankle Case report IV 1 1 0.0 46.0 8/16
Jentzsch et al34 2016 Switzerland Oncology Case series IV 4 4 25.0 40.0 11/6
Jeuken et al35 2017 Netherlands Pediatrics Case report IV 1 1 100.0 15.0 7/16
Kieser et al36 2018 New Zealand Arthroplasty/reconstructive Case series IV 36 36 44.4 68.0 12/16
Kim et al37 2015 South Korea Trauma Case series IV 7 7 NR NR 7/16
Kim et al38 2018 South Korea Arthroplasty/reconstructive Retrospective cohort study III 40 20 82.5 55.4 14/24
Lau et al39 2018 China Trauma Case report IV 1 1 NR 57.0 8/16
Li et al40 2018 China Arthroplasty/reconstructive Prospective cohort study II 40 20 37.5 41.0 17/24
Li et al41 2016 China Arthroplasty/reconstructive Case series IV 24 24 66.7 65.0 14/16
Li et al42 2017 China Trauma Retrospective cohort study III 64 28 28.1 33.6 21/24
Lin et al43 2018 Taiwan Trauma Case report IV 1 1 0.0 64.0 5/16
Liu et al44 2018 China Oncology Case report IV 1 1 0.0 16.0 5/16
Lou et al45 2017 China Trauma RCT II 72 34 47.2 53.4 N/A, see Fig. 4
Lu et al46 2018 China Oncology Case series IV 11 11 45.5 38.0 13/16
Lu et al47 2018 China Oncology Case report IV 1 1 0.0 15.0 10/16
Luo et al48 2017 China Oncology Case series IV 4 4 75.0 49.0 14/16
Ma et al49 2017 China Oncology Case series IV 12 12 16.7 22.8 13/16
Ma et al50 2016 China Oncology Case series IV 8 8 37.5 17.5 14/16
Maini et al51 2016 India Trauma RCT I 21 11 14.3 38.7 N/A, see Fig. 4
Mao et al52 2015 China Arthroplasty/reconstructive Case series IV 22 22 NR 60.9 12/16
Merema et al53 2017 Netherlands Trauma Case report IV 1 1 0.0 48.0 10/16
Nie et al54 2018 China Trauma Case series IV 30 30 40.0 30.4 5/16
Niikura et al55 2014 Japan Trauma Case series IV 5 5 NR NR 7/16
Nizam and Batra56 2018 Australia Arthroplasty/reconstructive Case series IV 188 188 62.8 67.7 7/16
Ogura et al57 2018 USA Arthroplasty/reconstructive Case series IV 55 55 64.0 51.0 8/16
Okoroha et al58 2018 USA Sports Case report IV 1 1 100.0 26.0 4/16
Osagie et al59 2017 UK Upper extremity Case series IV 3 3 0.0 34.3 6/16
Pérez-Mananes et al60 2016 Spain Arthroplasty/reconstructive Retrospective cohort study III 28 8 NR 44.7 19/24
Ranalletta et al61 2017 Argentina Upper extremity Case report IV 1 1 100.0 28.0 7/16
Ren et al62 2017 China Oncology Case report IV 1 1 100.0 17.0 7/16
Roner et al63 2018 Switzerland Upper extremity Case series IV 15 8 NR NR 6/24
Sánchez-Perez et al64 2018 Spain Arthroplasty/reconstructive Case report IV 1 1 0.0 43.0 9/16
Sanghavi and Jankharia65 2016 India Trauma Case report IV 1 1 0.0 45.0 0/16
Schneider et al66 2018 Australia Arthroplasty/reconstructive Case series IV 30 30 50.0 63.9 7/16
Sheth et al67 2015 Canada Sports Case report IV 1 1 0.0 29.0 6/16
Shi et al68 2018 China Arthroplasty/reconstructive Prospective cohort study II 33 12 63.6 47.3 16/24
Shon et al69 2018 South Korea Trauma Case series IV 5 5 40.0 41.4 8/16
Shuang et al70 2016 China Trauma RCT II 13 6 23.1 43.0 N/A, see Fig. 4
Simal et al71 2016 Spain Oncology Case report IV 1 1 0.0 14.0 6/16
Smith et al72 2016 USA Foot and ankle Case series IV 2 2 100.0 40.0 10/16
So et al73 2018 USA Foot and ankle Case series IV 3 3 100.0 44.0 11/16
Stoffelen et al74 2015 Belgium Upper extremity Case report IV 1 1 100.0 56.0 8/16
Tam et al75 2012 UK Oncology Case report IV 1 1 100.0 65.0 2/16
Tran et al76 2018 Australia Oncology Case report IV 1 1 100.0 39.0 6/16
Upex et al77 2016 France Trauma Case report IV 1 1 0.0 39.0 2/16
Wada et al78 2018 Japan Arthroplasty/reconstructive Case report IV 1 1 100.0 79.0 8/16
Wang et al79 2017 China Oncology Case series IV 11 11 54.5 47.0 12/16
Wang et al80 2017 China Trauma Case report IV 1 1 100.0 53.0 6/16
Wang et al81 2017 China Oncology RCT II 66 33 42.4 43.6 N/A, see Fig. 4
Wang et al82 2018 China Trauma Retrospective cohort study III 46 21 69.6 71.5 15/24
Wang et al83 2017 China Trauma Case series IV 6 6 50.0 43.7 8/16
Wang et al84 2017 China Arthroplasty/reconstructive Retrospective cohort study III 74 17 50.0 62.7 22/24
Wong et al85 2015 China Oncology Case report IV 1 1 0.0 65.0 8/16
Wu et al86 2015 China Trauma Case series IV 9 9 22.2 47.0 10/16
Xie et al87 2017 China Upper extremity Case report IV 1 1 NR 41.0 10/16
Xu et al88 2015 China Arthroplasty/reconstructive Case series IV 10 10 90.0 57.8 13/16
Yang et al89 2016 China Oncology Case report IV 1 1 100.0 78.0 6/16
Yang et al90 2017 China Trauma RCT I 40 20 30.0 38.6 N/A, see Fig. 4
Yang et al91 2016 China Trauma RCT II 30 15 46.7 36.5 N/A, see Fig. 4
Yang et al92 2016 China Trauma Case series IV 7 7 57.1 44.0 12/16
You et al93 2016 China Trauma RCT I 66 34 59.1 66.2 N/A, see Fig. 4
Yu et al94 2015 UK Trauma Case series IV 2 2 NR 52.0 1/16
Zang et al95 2017 China Upper extremity Case series IV 5 5 20.0 28.0 10/16
Zeng et al96 2015 China Trauma Case series IV 38 38 34.2 32.0 13/16
Zeng et al97 2016 China Trauma Case series IV 10 10 50.0 19.0–52.0 8/16
Zerr et al98 2016 USA Arthroplasty/reconstructive Case report IV 1 1 100.0 70.0 7/16
Zhang et al99 2017 China Trauma Case series IV 78 78 47.4 56.0 10/16
Zhang et al100 2017 China Oncology Case report IV 1 1 0.0 36.0 6/16
Zhang et al101 2018 China Arthroplasty/reconstructive Case series IV 30 30 36.7 41.7 9/16
Zheng et al102 2017 China Paediatrics Prospective cohort study II 25 12 84.0 10.9 23/24
Zheng et al103 2017 China Paediatrics Retrospective cohort study III 11 11 36.4 6.6 18 /24
Zheng et al104 2017 China Trauma Prospective cohort study II 39 19 43.6 66.0 23/24
Zheng et al105 2017 China Trauma RCT II 91 43 46.2 44.6 N/A, see Fig. 4
Zheng et al106 2018 China Trauma RCT I 100 50 NR 41.9 N/A, see Fig. 4
Zheng et al107 2017 China Trauma RCT I 75 35 41.3 45.7 N/A, see Fig. 4
Zhuang et al108 2016 China Trauma Case series IV 12 12 33.3 49.0 10/16

Note. LOE, level of evidence; 3DP, three-dimensional printing; MINORS, Methodological Index for Non-Randomized Studies; NR, not reported; RCT, randomized controlled trial.

A total of 2328 patients were included in the 108 studies, and 1558 patients were treated with the use of 3D printing technology. The mean age of the combined patient population in 99 of the 108 studies (2126 patients) was 47.0 years old (range, 3 to 90 years), with the remaining studies not reporting age. Table 1 outlines the basic characteristics of all included studies. Appendix 2 contains a full reference list of all included studies.

The mean MINORS score for the 78 non-comparative studies was 8.3 out of 16 (range, 0–14) and for the 19 non-randomized comparative studies it was 17.7 out of 24 (range, 6–23). A risk of bias assessment was performed on the 11 RCTs using the Cochrane Collaboration Risk of Bias Assessment Tool (Fig. 4). High bias was observed in 100% of RCTs for performance and detection bias. Due to the nature of 3D printing technology, it would be extremely difficult to blind surgeons to the intervention used. Additionally, EBL was measured subjectively, which could have been influenced by the lack of blinding. Low bias was observed in all RCTs for attrition bias, reporting bias, and other bias. Nearly half (45%) of RCTs had a low risk of bias for random sequence generation, and 45% of RCTs had an unclear risk of bias in this domain. All RCTs had an unclear risk of bias in allocation concealment.

Fig. 4
Fig. 4

Risk of bias assessment diagram.

Citation: EFORT Open Reviews 5, 7; 10.1302/2058-5241.5.190024

3D printing characteristics

Uses of 3D printing

The uses of 3D printing were divided into three main categories: surgical models for pre-operative planning, PSI (e.g. cutting guides, etc. that are then used intra-operatively), and final implants (e.g. custom plates, etc.). The most common use of 3D printing was for pre-operative planning (N = 63), followed by final implants (N = 32) and PSI (N = 22). Some studies reported more than one category of use.

Three-dimensional printing was most commonly used in trauma (N = 41), oncology (N = 22), and arthroplasty/reconstruction (N = 18) (Table 2). There were some differences in the categories of 3D printing use between subspecialties. Though pre-operative planning was the most common use of 3D printing in most subspecialties, printing of final implants was the most common purpose of 3D printing in oncology and foot and ankle. Finally, PSI was relatively more common in paediatrics, where it accounted for 60.0% of the reported applications of 3D printing.

Table 2.

Subspecialties most commonly reporting the use of three-dimensional printing

Subspecialty Number of studies reporting (%)
Trauma 41 (38.0%)
Oncology 22 (20.4%)
Arthroplasty/reconstruction 18 (16.7%)
Upper extremity 10 (9.3%)
Foot and ankle 9 (8.3%)
Paediatrics 5 (4.6%)
Sports 2 (1.9%)
Multiple subspecialties 1 (0.9%)

Note. Based on all 108 studies; some studies reported on more than one subspecialty.

Materials used in 3D printing

The most commonly used 3D printing materials were titanium (16 studies, 27.1%), acrylonitrile butadiene styrene (13 studies, 22.0%), and polylactic acid (13 studies, 22.0%). Table 3 outlines the details of all reported material. The majority of surgical models were made of acrylonitrile butadiene styrene, and most final implants used titanium. Only four studies reporting use of titanium specified details about the composition of the alloy utilized: all four used Ti6Al4V with a patented truss structure.

Table 3.

Materials used for three-dimensional printing

Material Number of studies reporting (%)
Titanium 16 (27.1%)
Acrylonitrile butadiene styrene 13 (22.0%)
Polylactic acid 13 (22.0%)
Plaster 5 (8.5%)
Polyamide 4 (6.8%)
Polyethylene 4 (6.8%)
Other polymer 3 (5.1%)
Ultraviolet curable resin 1 (1.7%)

Note. Based on 57 studies reporting; two studies each reported two different materials used.

Cost

Twenty-five studies (23.1%) reported on 3D printing cost, with a range from ‘less than $10’ to $20,000 dollars. Not surprisingly, the highest costs were associated with studies that were 3D printing a final implant (range $4,750–$20,000). Interestingly, the two studies which reported on the cost of printing PSI reported costs of ‘less than 5 euros’ and $150. The cost of pre-operative planning models ranged from ‘less than $10’ to $2,200. Time required to edit and print 3D models was also quite variably reported in 32 studies (29.6%), ranging from three hours to six weeks. Most studies did not distinguish between the time required for each stage of the 3D printing process (image editing, physical printing, sterilization, etc.).

Qualitative analysis of peri-operative outcomes

Seventeen high-quality studies (ten RCTs, seven prospective cohorts) including 864 patients, examined the difference in operative time between cases where 3D printing was used and controls. Fifteen of 17 studies (88.2%) found significantly shorter operative times in 3D printing cases as opposed to standard cases. Two studies found statistically non-significant differences between the two groups: one study found shorter operative time in the 3D printing group, while the other found the opposite. Among studies with statistical significance, the difference in mean operative time between the two groups ranged from 9 to 27 minutes (see Fig. 5a).

Fig. 5a
Fig. 5a

Forest plot of estimated blood loss based on high-quality studies.

Citation: EFORT Open Reviews 5, 7; 10.1302/2058-5241.5.190024

Thirteen high-quality studies (eight RCTs, five prospective cohorts) including 780 patients, assessed the difference in estimated blood loss (EBL) between 3D printing patients and control patients. Of these, 11 studies (84.6%) found significantly lower EBL in the 3D printing groups. The other two studies also found lower EBL in the 3D printing groups though this difference was not statistically significant. Among studies with significant findings, the difference in mean EBL ranged from 14 mL to 100 mL (see Fig. 5b).

Fig. 5b
Fig. 5b

Forest plot of operative time based on high-quality studies.

Citation: EFORT Open Reviews 5, 7; 10.1302/2058-5241.5.190024

Thirteen high-quality studies (four RCTs, six prospective cohorts) including 631 patients, compared the number of fluoroscopy shots used intra-operatively. All 13 studies (100%) found significantly fewer fluoroscopy shots during cases that used 3D printing compared to controls. The difference in mean number of fluoroscopy shots taken ranged from 1 to 29 shots (see Fig. 5c).

Fig. 5c
Fig. 5c

Forest plot of fluoroscopy shots based on high-quality studies.

Citation: EFORT Open Reviews 5, 7; 10.1302/2058-5241.5.190024

Discussion

The key findings of this review were that 3D printing is being used with increasing frequency in peri-operative orthopaedics and is most commonly reported in trauma and oncology. The most common application of 3D printing is for pre-operative planning. The majority of 3D printing research in orthopaedics is based in Asia, particularly in China. In addition, the Level I and Level II evidence consistently finds shorter operative times, 2843 less blood loss, 2830,3238,4143 and less fluoroscopy use 28,30,31,3337,44,45 when 3D printing is used.

Across an overwhelming majority of the high-quality literature, the use of 3D printing significantly reduced operative time, 2843 EBL, 2830,3238,4143 and the number of fluoroscopy shots. 28,30,31,3337,44,45 It is difficult to evaluate the clinical significance of these findings given the significant heterogeneity in terms of clinical context between the different studies. Nonetheless, a reduction in operative time is certainly beneficial from a cost perspective, and, given that the risk of complications increases with longer operative times, 46 it is reasonable to hypothesize that this is beneficial to the patient as well. Similarly, a reduction in EBL has a theoretical safety benefit to the patient, though it is unclear what the threshold for clinical benefit would be. Certainly, if blood transfusion rates were to be decreased, this would represent an important patient benefit. 47 Finally, fewer fluoroscopy shots may not necessarily have a direct impact on the patient, but are important for the safety of operating room staff, particularly in the long term. 48 Given the wide range of different operations included in this review, it is difficult to know whether or not these benefits of 3D printing are globally present or clinically important. That being said, the consistently significant findings across the majority of prospective comparative studies suggest the possibility of a true signal, and this warrants further study with larger RCTs to clarify the magnitude of this effect.

Pre-operative planning is an essential part of any successful operation. With the increasing availability of 3D printing technology, surgeons and learners can use a physical, high-fidelity model to review and plan for complex cases with accurate depth perception and haptic feedback. In a retrospective study, Mainard et al found that the use of 3D models was more accurate than traditional two-dimensional templating in total hip arthroplasty. 49 They hypothesized that the ability to plan using an actual size model (as opposed to magnified images), and the ability to simultaneously assess length, alignment, and rotation in multiple planes were some reasons for improved accuracy. 49 With the advent of the use of virtual reality (VR) in surgical planning and education, 50 future studies comparing VR and 3D printing can elucidate the importance of the haptic feedback.

As it is a new technology, the cost of 3D printing is a concern, particularly when being considered for use in a publicly funded healthcare system. It can be difficult to gauge the true cost of any new piece of technology: beyond the cost of the hardware itself, there are costs associated with energy usage, personnel training, ancillary software costs, and maintenance and repair expenditures. In the case of 3D printing in orthopaedics, other specific costs such as storage, encryption, and sterilization are also important to consider. The studies included in this review reported cost in a number of different ways, if at all, making it difficult to draw direct comparisons. Overall, however, there is no doubt that the cost of 3D printing technology, including both hardware and software, has decreased dramatically in recent years. 51 Interestingly, many of the included studies were able to achieve their 3D printing requirements for less than US$100. Given the potential for reduced operative time and fluoroscopy use, a careful economic analysis is needed to assess the cost-effectiveness of 3D printing technology in orthopaedic surgery.

With the increasing focus on competency-based education, combined with reduced work hours for surgical residents, 52 there is a growing need for high-fidelity educational models that can be deployed outside the operating room. Though this review focused on the clinical applications of 3D printing, its educational uses are also abundant and increasing. Three dimensional printing of complex fracture patterns such as acetabular and calcaneal fractures has been shown to improve consistency in fracture classification and patient understanding of the fracture and surgical plan. 9,34 With the growing focus on minimizing patient harm and competency-based education, 3D printing has the potential to play a key role in the future of orthopaedic education.

Strengths

The strengths of this review stem from its thorough methodology, broad inclusion criteria, and current relevance. Inclusion criteria were kept intentionally broad given that this is a relatively new field and thus keywords and Medical Subject Heading terms may be heterogeneously used. Additionally, strict adherence to PRISMA guidelines make this a methodologically sound review. Finally, the qualitative analysis of high-quality evidence provides important insights into the potential peri-operative benefits of 3D printing.

Limitations

This review was primarily limited by the overall low level of evidence available, with the majority of studies being Level IV evidence. In addition, data on the cost and time required to complete 3D prints was inconsistently reported, making it difficult to draw conclusions on these important facets of the technology. As discussed above, the heterogeneity of the included studies precluded a meta-analysis. Finally, the heterogeneity in population, applications, and reporting of outcomes meant that an analysis of functional outcomes could not be performed.

Future directions

As the orthopaedic applications of 3D printing continue to grow, it is important that they are critically evaluated to ensure that these applications are in the best interest of patients. There is a need for larger RCTs to further assess the potential benefits of 3D printing. More consistent reporting of detailed cost breakdown is important to aid future economic analyses of 3D printing in order to ascertain its cost-effectiveness and optimal indications. Finally, an evaluation of the educational uses of 3D printing in orthopaedics is required.

Conclusions

The uses of 3D printing in orthopaedic surgery are growing rapidly, with its use being most common in trauma and oncology. Pre-operative planning is the most common use of 3D printing in orthopaedics. The use of 3D printing significantly reduces EBL, operative time, and fluoroscopy use compared to controls. Future research is needed to confirm and clarify the magnitude of these effects.

Open access

This article is distributed under the terms of the Creative Commons Attribution-Non Commercial 4.0 International (CC BY-NC 4.0) licence (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed.

ICMJE Conflict of interest statement

SE reports grants from the Research Institute of St. Joseph’s Healthcare Hamilton, PSI Foundation and Michael G. DeGroote Fellowship, not related to the submitted work. DSW is a consultant for Stryker and Intellijoint.

The other authors declare no conflict of interest relevant to this work.

Funding statement

The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.

Supplemental Material

Supplemental material is available online alongside this paper at https://doi.org/10.1302/2058-5241.5.190024

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Supplementary Materials

 

  • Collapse
  • Expand
EFORT logo
  • View in gallery
    Fig. 1

    Conceptual representation of additive vs. subtractive manufacturing.

    Source. Modified from the United States Government Accountability Office.

  • View in gallery
    Fig. 2

    PRISMA flow diagram.

  • View in gallery
    Fig. 3

    Number of included studies by year.

    Note. Data from 2018 does not include the full year as the search was performed in November 2018.

  • View in gallery
    Fig. 4

    Risk of bias assessment diagram.

  • View in gallery
    Fig. 5a

    Forest plot of estimated blood loss based on high-quality studies.

  • View in gallery
    Fig. 5b

    Forest plot of operative time based on high-quality studies.

  • View in gallery
    Fig. 5c

    Forest plot of fluoroscopy shots based on high-quality studies.

  • 1.

    3DPI. 3D printing history: the free beginner’s guide. 3D Printing Industry, 2014. https://3dprintingindustry.com/3d-printing-basics-free-beginners-guide/history/%5Cnhttp://3dprintingindustry.com/3d-printing-basics-free-beginners-guide/history/%5Cnhttp://3dprintingindustry.com/wp-content/uploads/2014/07/3D-Printing-Guide.pdf (date last accessed 16 January 2019).

    • Search Google Scholar
    • Export Citation
  • 2.

    Zhakeyev A , Wang P , Zhang L , Shu W , Wang H , Xuan J . Additive manufacturing: unlocking the evolution of energy materials. Adv Sci (Weinh) 2017; 4:1700187 .

    • Search Google Scholar
    • Export Citation
  • 3.

    Baumers M , Holweg M , Rowley J . The economics of 3D printing: a total cost perspective, 2016. https://www.ifm.eng.cam.ac.uk/uploads/Research/TEG/3DP-RDM_Total_cost_report.pdf (date last accessed 16 January 2019).

    • Search Google Scholar
    • Export Citation
  • 4.

    Palo M , Holländer J , Suominen J , Yliruusi J , Sandler N . 3D printed drug delivery devices: perspectives and technical challenges. Expert Rev Med Devices 2017; 14:685696 .

    • Search Google Scholar
    • Export Citation
  • 5.

    Holländer J , Genina N & Jukarainen H et al. Three-dimensional printed PCL-based implantable prototypes of medical devices for controlled drug delivery. J Pharm Sci 2016; 105:26652676 .

    • Search Google Scholar
    • Export Citation
  • 6.

    Pavlosky A , Glauche J , Chambers S , Al-Alawi M , Yanev K , Loubani T . Validation of an effective, low cost, free/open access 3D-printed stethoscope. PLoS One 2018; 13:e0193087 .

    • Search Google Scholar
    • Export Citation
  • 7.

    Ventola CL . Medical applications for 3D printing: current and projected uses. P T 2014; 39:704711 .

  • 8.

    Klein GT , Lu Y , Wang MY . 3D printing and neurosurgery: ready for prime time? World Neurosurg 2013; 80:233235 .

  • 9.

    Brouwers L , Pull ter Gunne A & de Jongh M et al. The value of 3D printed models in understanding acetabular fractures. 3D Print Addit Manuf 2018;5 .

    • Search Google Scholar
    • Export Citation
  • 10.

    Huang Z , Song W & Zhang Y et al. Three-dimensional printing model improves morphological understanding in acetabular fracture learning: a multicenter, randomized, controlled study. PLoS One 2018; 13:e0191328 .

    • Search Google Scholar
    • Export Citation
  • 11.

    Bagaria V , Chaudhary K . A paradigm shift in surgical planning and simulation using 3Dgraphy: experience of first 50 surgeries done using 3D-printed biomodels. Injury 2017; 48:25012508 .

    • Search Google Scholar
    • Export Citation
  • 12.

    Bizzotto N , Tami I , Santucci A , Romani D , Cosentino A III . Printed replica of articular fractures for surgical planning and patient consent: a 3 years multi-centric experience. Mater Today Commun 2018; 15:309313 .

    • Search Google Scholar
    • Export Citation
  • 13.

    Bizzotto N , Tami I & Tami A et al. 3D printed models of distal radius fractures. Injury 2016; 47:976978 .

  • 14.

    Ranalletta M , Bertona A & Rios JM et al. Corrective osteotomy for malunion of proximal humerus using a custom-made surgical guide based on three-dimensional computer planning: case report. J Shoulder Elbow Surg 2017; 26:e357e363 .

    • Search Google Scholar
    • Export Citation
  • 15.

    Lau CK , Chui K , Lee K , Li W . Computer-assisted planning and three-dimensional-printed patient-specific instrumental guide for corrective osteotomy in post-traumatic femur deformity: a case report and literature review. J Orthop Trauma Rehabil 2018; 24:1217 .

    • Search Google Scholar
    • Export Citation
  • 16.

    Pérez-Mañanes R , Burró JA , Manaute JR , Rodriguez FC , Martín JV . 3D surgical printing cutting guides for open-wedge high tibial osteotomy: do it yourself. J Knee Surg 2016; 29:690695 .

    • Search Google Scholar
    • Export Citation
  • 17.

    Citak M , Kochsiek L , Gehrke T , Haasper C , Suero EM , Mau H . Preliminary results of a 3D-printed acetabular component in the management of extensive defects. Hip Int 2018; 28:266271 .

    • Search Google Scholar
    • Export Citation
  • 18.

    Xie MM , Tang KL , Yuan CS . 3D printing lunate prosthesis for stage IIIc Kienböck’s disease: a case report. Arch Orthop Trauma Surg 2018; 138:447451 .

    • Search Google Scholar
    • Export Citation
  • 19.

    Wang S , Wang L & Liu Y et al. 3D printing technology used in severe hip deformity. Exp Ther Med 2017; 14:25952599 .

  • 20.

    Auricchio F , Marconi S . 3D printing: clinical applications in orthopaedics and traumatology. EFORT Open Rev 2017; 1:121127 .

  • 21.

    Mulford JS , Babazadeh S , Mackay N . Three-dimensional printing in orthopaedic surgery: review of current and future applications. ANZ J Surg 2016; 86:648653 .

    • Search Google Scholar
    • Export Citation
  • 22.

    Wilcox B , Mobbs RJ , Wu A-M , Phan K . Systematic review of 3D printing in spinal surgery: the current state of play. J Spine Surg 2017; 3:433443 .

    • Search Google Scholar
    • Export Citation
  • 23.

    Higgins JPT , Thomas J , Chandler J , Cumpston M , Li T , Page MJ , Welch VA , eds. Cochrane handbook for systematic reviews of interventions. Chichester, UK: Wiley .

    • Search Google Scholar
    • Export Citation
  • 24.

    Moher D , Liberati A , Tetzlaff J , Altman DG ; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009; 6:e1000097 .

    • Search Google Scholar
    • Export Citation
  • 25.

    Higgins JPT , Altman DG , Gøtzsche PC , et al; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011; 343:d5928 .

    • Search Google Scholar
    • Export Citation
  • 26.

    Slim K , Nini E , Forestier D , Kwiatkowski F , Panis Y , Chipponi J . Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg 2003; 73:712716 .

    • Search Google Scholar
    • Export Citation
  • 27.

    McGinn T , Wyer PC , Newman TB , Keitz S , Leipzig R , For GG; Evidence-Based Medicine Teaching Tips Working Group. Tips for learners of evidence-based medicine: 3. Measures of observer variability (kappa statistic). CMAJ 2004; 171:13691373 .

    • Search Google Scholar
    • Export Citation
  • 28.

    Cai L , Zhang C , Wang J , Guo X , Zhou Y . Treatment of die-punch fractures with 3D printing technology. J Invest Surg 2018; 31:385392 .

  • 29.

    Giannetti S , Bizzotto N , Stancati A , Santucci A . Minimally invasive fixation in tibial plateau fractures using an pre-operative and intra-operative real size 3D printing. Injury 2017; 48:784788 .

    • Search Google Scholar
    • Export Citation
  • 30.

    You W , Liu LJ & Chen HX et al. Application of 3D printing technology on the treatment of complex proximal humeral fractures (Neer3-part and 4-part) in old people. Orthop Traumatol Surg Res 2016; 102:897903 .

    • Search Google Scholar
    • Export Citation
  • 31.

    Zheng P , Xu P , Yao Q , Tang K , Lou Y . 3D-printed navigation template in proximal femoral osteotomy for older children with developmental dysplasia of the hip. Sci Rep 2017; 7:44993 .

    • Search Google Scholar
    • Export Citation
  • 32.

    Zheng SN , Yao QQ & Mao FY et al. Application of 3D printing rapid prototyping-assisted percutaneous fixation in the treatment of intertrochanteric fracture. Exp Ther Med 2017; 14:36443650 .

    • Search Google Scholar
    • Export Citation
  • 33.

    Zheng W , Su J & Cai L et al. Application of 3D-printing technology in the treatment of humeral intercondylar fractures. Orthop Traumatol Surg Res 2018; 104:8388 .

    • Search Google Scholar
    • Export Citation
  • 34.

    Zheng W , Tao Z & Lou Y et al. Comparison of the conventional surgery and the surgery assisted by 3D printing technology in the treatment of calcaneal fractures. J Investig Surg 2017; 31:557567 .

    • Search Google Scholar
    • Export Citation
  • 35.

    Zheng W , Chen C , Zhang C , Tao Z , Cai L . The feasibility of 3D printing technology on the treatment of pilon fracture and its effect on doctor–patient communication. BioMed Res Int 2018; 2018:8054698 .

    • Search Google Scholar
    • Export Citation
  • 36.

    Li B , Lei P & Liu H et al. Clinical value of 3D printing guide plate in core decompression plus porous bioceramics rod placement for the treatment of early osteonecrosis of the femoral head. J Orthop Surg Res 2018; 13:130 .

    • Search Google Scholar
    • Export Citation
  • 37.

    Lou Y , Cai L & Wang C et al. Comparison of traditional surgery and surgery assisted by three dimensional printing technology in the treatment of tibial plateau fractures. Int Orthop 2017; 41:18751880 .

    • Search Google Scholar
    • Export Citation
  • 38.

    Maini L , Sharma A , Jha S , Sharma A , Tiwari A . Three-dimensional printing and patient-specific pre-contoured plate: future of acetabulum fracture fixation? Eur J Trauma Emerg Surg 2018; 44:215224 .

    • Search Google Scholar
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