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Disability and Rehabilitation: Assistive Technology

ISSN: 1748-3107 (Print) 1748-3115 (Online) Journal homepage: https://www.tandfonline.com/loi/iidt20

3D printing and amputation: a scoping review

Danielle Ribeiro, Stephanie R. Cimino, Amanda L. Mayo, Matt Ratto & Sander
L. Hitzig

To cite this article: Danielle Ribeiro, Stephanie R. Cimino, Amanda L. Mayo, Matt Ratto & Sander
L. Hitzig (2019): 3D printing and amputation: a scoping review, Disability and Rehabilitation:
Assistive Technology, DOI: 10.1080/17483107.2019.1646825

To link to this article: https://doi.org/10.1080/17483107.2019.1646825

Published online: 16 Aug 2019.

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DISABILITY AND REHABILITATION: ASSISTIVE TECHNOLOGY
https://doi.org/10.1080/17483107.2019.1646825

REVIEW

3D printing and amputation: a scoping review


Danielle Ribeiroa, Stephanie R. Ciminob, Amanda L. Mayoc,d, Matt Rattoe and Sander L. Hitzigb,e,f,g
a
Department of Electrical, Computer and Biomedical Engineering, Faculty of Engineering and Architectural Science, Ryerson University, Toronto,
Canada; bSt. John’s Rehab Research Program, Evaluative Clinical Sciences, Sunnybrook Research Institute, Toronto, Canada; cSt. John’s
Rehabilitation Hospital, Sunnybrook Health Sciences Centre, Toronto, Canada; dFaculty of Medicine, University of Toronto, Toronto, Canada;
e
Faculty of Information, University of Toronto, Toronto, Canada; fDepartment of Occupational Science & Occupational Therapy, Faculty of
Medicine, University of Toronto, Toronto, Canada; gRehabilitation Sciences Institute, Faculty of Medicine, University of Toronto,
Toronto, Canada

ABSTRACT ARTICLE HISTORY


Purpose: Three-dimensional (3D) printing is an innovative technology being utilized to create prostheses Received 24 October 2018
for individuals with limb loss. However, there is a paucity of research on the feasibility of using this tech- Revised 11 June 2019
nology to fabricate prostheses. A scoping review was conducted to map the literature on 3D printing Accepted 18 July 2019
and its applications in the field of amputation.
KEYWORDS
Materials and methods: Using a scoping review framework, a systematic literature search was conducted 3D printing; amputation;
in three electronic databases (MEDLINE, EMBASE and CINAHL) for all indexed literature up to 29 prosthetics; prosthet-
June 2018. ist; review
Results: Twenty-eight articles met the inclusion criteria. The majority of studies had small sample sizes
(five participants or less; n ¼ 20) and used a case study design (n ¼ 17). The benefits of 3D printing tech-
nology include higher levels of customization and lower production costs. However, the functionality of
3D printed prostheses is lacking. There is also a need for more robust research designs to obtain a better
understanding of the advantages and disadvantages of 3D printed prostheses and its impact on end-
user outcomes.
Conclusions: The use of 3D printing technology has a number of benefits for improving the manufactur-
ing process of devices for people with lower and upper limb loss. However, more research and techno-
logical advancements are required to fully understand the impact of this technology on patients and
how it will affect their daily life. The long-term effects of this technology will also need to be investigated
in order to produce a more sustainable alternative to traditional prostheses.

ä IMPLICATIONS FOR REHABILITATION


 The use of 3D printing technology for the fabrication of prosthetics for persons with limb-loss has a
number of promising features to improve the fitting and customization of these devices for this
patient population.
 Although the costs of producing 3D printed devices is less expensive and burdensome than trad-
itional approaches to manufacturing techniques, there is a need for additional technological advance-
ments to improve the functionality of these devices.
 Future research needs to adopt more robust research designs with larger sample sizes to provide a
better understanding of the viability of using 3D printing technology to improve patient outcomes.

Introduction
fabrication process, a plaster cast is placed manually onto the
Since 1500 BC, a prosthetic has been the standard approach patient’s residual limb to create a first mould of the lost extremity
towards enabling the individual who has lost a limb to regain [6]. This mould is then filled with a cement mixture, which when
their functional independence [1]. Although the field is centuries set will be destroyed in order to release the positive cement
old, the prosthetic industry has only evolved considerably over mould. Prosthetists then rectify and shape the positive mould to
the past decade due to the emergence of new technologies [2–5]. reinforce areas of the limb that endure more pressure, stress and
As a result of these advances in the fitting and fabrication pro- strain [6]. Once a final representation of the prosthetic is created,
cess, modern prosthetics have the potential to significantly fibre-reinforced resin or thermoplastic material is heated and care-
improve the quality of life of persons with limb loss by providing fully placed over the mould and cured in an oven [2,6]. At this
devices to them with greater ease and comfort [5]. stage, the positive mould of the lost extremity is destroyed [3].
Traditional prosthetics can have several drawbacks as casting Destruction of these casts means that the entire fabrication pro-
methods involve a considerable amount of manual labour to fab- cess will have to be restarted if the resulting product is not an
ricate, fit and refit each prosthetic. During the traditional adequate fit for the patient [3,6]. Not only are traditional casting

CONTACT Sander L. Hitzig sander.hitzig@sunnybrook.ca St. John’s Rehab Research Program, Sunnybrook Research Institute, 285 Cummer Avenue, Toronto,
Ontario, M2M 2G1, Canada
ß 2019 Informa UK Limited, trading as Taylor & Francis Group
2 D. RIBEIRO ET AL.

methods time-consuming and labour intensive, they can also be practice were developed to provide concrete suggestions to
expensive and difficult to modify or re-create [3]. advance the use of 3D printing in the field of prosthetics and
In addition to the fabrication process, there are a number of rehabilitation.
end-user (i.e., people with limb loss) concerns about their pros-
thetics, which include dissatisfaction with comfort, weight and
cost of their device [2,3]. These issues are common amongst vari- Methods
ous types of upper extremity prostheses; including myoelectric
The research team conducted this project utilizing the methodo-
prosthesis, body-powered prosthesis and passive prostheses [6].
logical framework of a scoping review [14]. Scoping reviews are
Although upper extremity prostheses can potentially restore
useful for mapping the existing literature on a topic, to examine
range of motion and grasp as well as a more life-like cosmetic
the nature of the research activity, to determine if undertaking a
appearance, issues of weight, poor sensory feedback and cost are
noted drawbacks [6]. Myoelectric devices are particularly heavy systematic review of a topic is of value, to disseminate research
for both upper- and lower-limb prosthetic users due to actuators findings and identify research gaps in the literature [14]. This
and motors within the prosthetic [7]. Sensory feedback on myo- scoping review followed the framework outlined by Arksey and
electric prostheses can also be problematic as it is difficult to O’Malley [14], with the five stage refinements proposed by
identify the specific muscle that will efficiently control the device Levac et al. [15].
[8]. Prosthetic costs rise with the complexity and/or aesthetics of
the device, as they require more manual labour, more sophisti-
cated components and costly materials to create an artificial limb Stage 1 – identifying research questions
with a more natural appearance [6]. The guiding research question for the review was: “What is the
A promising advancement in modern prosthetic fabrication state of knowledge about three-dimensional (3D) printing tech-
that alleviates a number of issues noted with traditional fabrica- nology for individuals with an amputation?”. The objectives of
tion methods has been the advent of three-dimensional (3D) this scoping review were: (1) to identify what types of research
printing. This technology encompasses a variety of different print- studies have been conducted on this topic; (2) what domains
ing methods; however, the most effective is rapid prototyping have been investigated? and (3) what have been the outcomes of
using an additive manufacturing process.[9] This process involves using 3D printing technology in persons with an amputation?
heating, excreting and fusing material layer-by-layer slowly build-
ing the object [10]. This differs from traditional prosthetic fabrica-
tion, which primarily employs a plaster cast to create a mould of Stage 2 – identifying relevant studies
the socket, which is then shaped by hand to create a custom fit
for the patient [2,3,6]. A computer-assisted search of all literature until 29 June 2018
The printing process requires that a scan of the extremity be was conducted. The literature search took place in June 2018 and
taken at multiple angles [11], which can be taken via X-ray, mag- electronic databases were utilized to search for articles relevant to
netic resonance imaging (MRI), computed tomography (CT) or by 3D prosthetic printing for individuals with an amputation.
a hand-held scanner [12]. The images taken are then manipulated Searches were conducted on three large online databases to
to generate a computerized model that can in turn be 3D printed. reflect the scope of this review. Databases included MEDLINE,
The complexity of the design of the prosthetic is insignificant as EMBASE and CINAHL. Subsequent searches were conducted by
the 3D printer can produce any design or shape necessary at vari- reviewing the reference list of the selected articles to ensure a
ous speeds [12]. More general, less customized 3D model files can thorough search. The following key terms were used to identify
be accessed and downloaded for free online, which can make the pertinent articles: “3D Printing”, “Additive Manufacturing”,
them available anywhere in the world where Internet access is “Rapid Prototyping”, “Amputation”, “Limb Loss”, “Prosthetic”,
available [12]. “Artificial Limb”, “Prosthetic Limb” and “Joint Prosthesis”.
These 3D files can be designed and printed using a variety of
materials such as polylactic acid (PLA) filament, nylon, thermoplas-
tic, polyvinyl alcohol (PVA) filament, etc. These materials vary in Stage 3 – selection of relevant studies
mechanical strength, flexibility and biocompatibility [5]. The
Articles considered for inclusion in this scoping review must have
choice of material will also determine the amount of stress and
met the following inclusion criteria: (1) any study that had at least
strain that can be exerted on the prosthetic. The costs, as well as
the weight of these 3D printed prosthetics, are significantly lower one person with an amputation; (2) articles discussing wearing,
than in traditional prosthetics [12]. This is due to the type of manufacturing or testing of 3D printed devices; (3) any language;
material used as well as the reduction in manual labour and man- (4) either traumatic or non-traumatic aetiologies and (5) any age
ufacturing costs [12]. In general, 3D printing offers a fast, custom- range. Studies were excluded if they were: (1) a review article,
izable, low-cost and lightweight approach to prosthetic device grey literature (e.g., PhD or MSc Theses) or book chapter; (2) con-
design and fabrication [11]. Given these attributes, 3D printing is ference abstracts or conference materials; (3) an animal study and
becoming a resource to improve accessibility of prosthetics in (4) a study examining facial prostheses.
rural and developing countries [11,13]. Despite the number of After the duplicate abstracts were removed, the full list of
seemingly positive attributes of this technology, the use of 3D abstracts was assessed by two independent reviewers. These
printing is still in its infancy and there remains much to learn reviewers screened the article abstracts to determine if they met
about the qualities of the prosthetics produced, and the impact the inclusion criteria. Following this step, the reviewers met to
of this technology on patients. To address this gap in knowledge, discuss any discrepancies in their inclusion or exclusion of the
the aim of this scoping review paper was to map the literature on articles for full-text review. Once consensus was obtained on the
3D printing and its applications in the field of amputation. From abstracts, the full-texts were thoroughly analyzed to ensure that
this review, key considerations for future research and clinical the eligibility criteria were met.
3D PRINTING AND AMPUTATION 3

Stage 4 – charting the data on the cost-effectiveness of 3D printing, which was attributed to
having less material, thereby leading to a reduction in material
Study characteristics and demographic variables of the included
costs, as well as manufacturing costs since less labour was
articles were summarized in descriptive summary tables (see
required. For instance, Day and Riley [30] noted that designing
Table 1). The information extracted included the primary
author(s), year of publication, study design, sample size, study and fabricating their 3D printed device was 56% cheaper than a
population and outcome measures. laminated device, and commented that it also improved cosmesis.
With regard to the customizability, 11 of the included articles
[20,24–26,28,30,34,35,37,40,41] provided commentary regarding
Stage 5 – collating, summarizing and reporting the results this feature. These devices were deemed extensively customizable
The full text of the included articles was then examined and the because all the fabrication plans regarding the devices are stored
necessary data were extracted. This data included a descriptive digitally, and can be modified with ease at any moment and be
numerical study and thematic analysis. Two members of the printed within days [4,34,35]. This customization enabled a more
authorship team (DR and SRC) independently reviewed the accurate representation of the amputated area; thereby allowing
included articles and the descriptive summary. Subsequently, the the device to fit the user more comfortably [21,32]. Finally, 11
two reviewers met with the senior responsible author (SLH) for articles [9,20,25,26,30–32,34,36,38,42] had commented on the
consultation meetings to arrive at mutually-agreed upon core cat- improved usability of the 3D printed device, which were mostly
egories, which were: (a) advantages of using 3D printing; (b) dis- focused on the fact they were lightweight because of the materi-
advantages of 3D printing and (c) suggestions for future als used to manufacture them. Every material varies in strength,
improvements. The iterative process to creating these categories flexibility and biocompatibility, and has a major impact on the
is consistent with a directive content analysis [16]. weight of the product.

Results Disadvantage of 3D printing


In total, 28 articles were included following the screening proc- Although there were positive aspects to the function of the 3D
esses (see Figure 1). The majority of the included studies were printed devices, a number of studies on hand prostheses noted a
completed in the USA (n ¼ 13) [17–29], which was followed by lack of functionality in a number of areas [17,18,20,25,28,
the UK (n ¼ 4) [9,30–32]. The remaining studies were spread out 35–35,37–40]. For instance, some studies noted a decrease in grip
across other countries in Asia (Korea, Japan, China and India, strength, durability and fine motor skills, which greatly impact
n ¼ 8) [4,33–39] as well as Portugal, Chile and Australia (n ¼ 3) everyday living and activities performed [17,18,20,28,34,38,39].
[40–42]). The most common study design utilized was a descrip- When fine motor skills are impeded, it can be increasingly difficult
tive case study design (n ¼ 17) [4,19–22,24,25,28,30,32,34,35, to perform certain tasks such as buttoning a shirt or tying shoes,
37,38,40–42]. Ten studies used an observational study design which can greatly affect one’s psychological and physical well-
[9,17,23,26,27,29,31,33,36,39] and only one study used a cross- being [7,20,28,34,35,38]. It was also noted by many participants
over randomized control trial [18]. Sample sizes for the literature that it was difficult to lift heavy objects; restricting tasks that can
in this field were small with most studies (n ¼ 20) having five par- be performed [25,38,40]. Cosmetic appearance was another qual-
ticipants or less [4,7–42]; 17 of the studies only had a single sub- ity that many users were displeased with due to the uncomfort-
ject [4,19–22,24,25,26,30,32,34,35,37,38,40–42]. With regards to
able mechanical feeling and appearance [34].
types of amputations, 17 studies were completed on individuals
with upper limb amputations [9,17,18,20,25–28,30,33–35,37–41];
with almost all (n ¼ 16) [9,17,18,20,25–27,30,33–35,37–41] being Suggestions for future improvements
on hand prostheses (including fingers) and the other one on the
The majority of the articles (n ¼ 23) provided suggestions on how
shoulder socket [28]. The remaining studies were completed in
to improve the use of 3D printing technology in order for this
individuals with a lower limb amputation (n ¼ 11) [4,9,19,
technology to be more widely accepted in the field of prosthetics
21–24,31,32,36,42]; with most of them involving individuals with a
and rehabilitation [4,17–24,26–35,37–40]. The three most common
below knee amputation (n ¼ 9) [4,9,19,21–24,31,36], with one
areas for further development that would significantly enhance
study looking at above knee amputations [32] and one study
the reliability and safety of these devices centred on functionality,
looking at a calcaneal amputation [42].
validity and durability of the devices. Six articles suggested that
With regard to the 3D printing technology, there was a lack of
consistency of the type of software, hardware and materials used more research is needed to determine long-term fatigue effects,
in producing the prostheses. The most commonly used software as well as whether these devices are capable of weight-bearing
program across studies was a variant of computer aided design [21,22,24,26,27,31]. There were noted concerns about the safety
(CAD) either on its own or in tandem with another program and reliability of 3D printed devices, and many suggested future
(n ¼ 17) [4,9,17,19–25,30,31,34,36,38,40,41]. PLA and acrylonitrile lines of inquiry to examine this issue [22,27,31]. Overall, several
butadiene styrene (ABS) plastic were the most commonly used authors noted that the technology still requires more improve-
materials [18,20,25–28,30,34,36–40]. ments if it is to make a substantial impact on the field of amputa-
tion [28,39,40].
South et al. [24] reflected upon the lack of peer-reviewed lit-
Advantages of 3D printing erature available on 3D printing and amputation. In terms of the
Although there were several noted benefits associated with 3D current methodological quality of the included studies, there were
printing prosthetic devices, there were three qualities that pre- several observed limitations. This included several of the studies
vailed as the most advantageous across the included studies: having small sample sizes, and being observational in design
cost-effectiveness, customization and being more lightweight. In [4,17,18,22]. There was only one study that employed a cross-over
terms of cost, 14 articles [20,23,26–28,30–35,37,38,41] commented randomized control trial [18]. There were no consistently used
Table 1. Summary of identified articles.

4
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings

D. RIBEIRO ET AL.
Dass Objective: To develop 3DP MP hand that Sample: Not described. General findings:
(2016) imitates the movement of other hand Amputation type(s): Partial hand  3DP prosthetic mimic’s movement of other hand
Location: India 3DP Technology: Not described amputation  Prosthetic hand can be controlled wirelessly without any
Study: Qualitative Materials: Patient history: Not described difficulties
Design:  3DP Prosthetic Hand Outcome: Prosthetic Hand Manipulation Advantages:
Observational Study Design  AT Mega 328 microcontroller  Capable of performing precise control of movements
based Arduino  Cost efficient & relatively small in size
 Flex Sensors  High degree of accuracy due to servo motors
 Servo Motors Disadvantages:
 RF 433 MHz Transmitter &  Human hand has 27 degrees of freedom while the prosthetic
Receiver module can only provide 6 degrees of freedom
Software: Arduino Future studies:
 To improve upon wirelessly controlled movements with
more ease
Gretsch et al. Objective: To develop an inexpensive 3DP Sample: N ¼ 1(female); 13 years old General findings:
(2016) prosthesis addressing limitations of the Amputation type(s): TRA  There are a limited amount of upper limb prostheses available
Location: USA Robohand Patient history: Not described for children
Study: Qualitative 3DP technology: Not described Outcome: Prosthetic hand manipulation  3DP to fit over ethylene based thermoplastic gel liner
Design: Materials: ABS plastic, motors, Arduino  Shoulder controlled & externally powered prosthesis enabling
Descriptive Case Study Design Microcontroller user to open & close all five fingers & move thumb
Software: Autodesk Inventor, CAD. independently
Advantages:
 Independent thumb was beneficial for grasping objects
 Weighed less than most externally powered prosthesis
 Size is scalable
 Family noted design financial feasibility
Disadvantages:
 # Battery life
 # Grip strength
 # Durability
Future studies:
 To improve upon prototype
Herbert et al. Objective: To investigate the use of a cheaper Sample: N ¼ 2 Amputation type(s): 1 General findings:
(2005) low-end rapid prototyping technology TTA & 1 TRA  Residual limb was scanned, 3DP & dried in a low temperature
Location: UK known as 3DP Patient history: Not described oven, then infiltrated with resin
Study: Qualitative 3DP technology: RP, Z Corporation Z402 3D Outcome: Prosthetic hand manipulation  Socket of prosthesis was wrapped in resin-reinforced carbon
Design: printer fibre allowing the patient to safely weight bear on
Observational study design Materials: Resin their prosthesis
Software: TracerCAD software, SolidView Pro.  Strength & durability of this prosthetic built with this
technology is unproven
Advantages:
 Straight forward to install & use.
 3DP prosthetic socket was as comfortable as
traditional methods.
Disadvantages: Not described.
Future Studies: Not described.
Lee et al. Objective: To compare hand functions of MP & Sample: N ¼ 1 (male); 52 years old General findings:
(2017) 3D-PSP Amputation type(s): TRA on right arm  Tested with a 9-hole pegboard test, BBT & hand strength
Location: Korea 3DP Technology: Artec Eva 3D scanner Patient history: 3D-PSP:
Study: Qualitative Materials: PLA, silicon  Put on medication to control pain,  Fabricated to sense pressure signals from sensor to perform
Design: Software: CAD software phantom pain & sleep disturbance voluntary opening & closing movements
Descriptive Case Study Design  Exercises were performed to  3D-PSP has the potential to positively impact the quality of life
enhance muscle strength for the person with amputation
(continued)
Table 1. Continued.
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
 Fitted with myoelectric & 3DP  3DP is used in medicine: 3D bio-printing for generation &
prosthesis at 2 months after injury transplantation of tissues
 Wound site was stable & volume  13 lbs
muscle was constant  Cost ¼ USD 440
Outcome: Prosthetic hand manipulation  Fabrication time ¼ 4 days
Myoelectric prosthesis:
 Operated using palmar prehension grasp
 Fabricated to sense voluntary motions of opening & closing
the hand
 30 lbs
 Limitations of 3DP prosthetics can be overcome proving to be
an appropriate method to current prostheses
 Cost ¼ USD 13,000
 Fabrication time ¼ 2 weeks
Advantages: 3D-PSP:
 # Cost, # fabrication time & it was lightweight
 Can easily print new devices when needed at a #cost
Myoelectric prosthesis:
 Patient performed better in MP
 Better hand strength & ability to perform everyday tasks
Disadvantages: 3DP:
 # Grip strength, # dexterity, strong mechanical feeling, difficult
to fabricate delicate parts facing amputation site
 Scanning errors
MP:
 # Battery life, motor noise, repulsed by cosmetic aestheticswas
not pleasing to patients
 # Grip strength, # durability
 Heavy
Future studies:
 To examine functionality, validity & durability of 3DP prosthesis
Swartz et al. (2017) Objective: To create a mechanism that would Sample: N ¼ 1 (male); 50 years old; General findings:
Location: USA interact with patient’s residual fingers Amputation type(s): Partial hand  Plastic is not strong enough which is why the final prosthetic
Study: Qualitative providing force & tactile feedback amputation on index finger & thumb is made out of aluminium
Design: Descriptive case study design 3DP Technology: FDM. of left hand (non-dominant hand)  Custom prostheses are becoming more readily available due to
Materials: ABS thermoplastic Patient history: easy access to open-source models online
Software: SolidWorks CAD software  Traumatic injury  Could not compare BBT scores as the patient did not have a
 No functional flexion, extension or previous prosthesis
supination of wrist  Patient no longer used this prosthesis due to lack of strength,
 Limited flexion & extension however he has been fit with i-digits system
Advantages:

3D PRINTING AND AMPUTATION


in fingers
 Challenging to use body powered  Patient had " functionality in performing daily tasks,
prosthesis due to length of completing the BBT
remaining fingers  Light weight
 Previously fitted with Disadvantages:
passive device  Limitations include language barrier, full acceptance of device,
 Prosthesis model was developed to lifting heavy objects & patients also deemed it moderately
have greater force & functionality difficult to complete tasks
as well as to decrease size of Future studies: Not described
prosthesis compared to traditional
hand prostheses
 Final prosthesis was made out of
7075-T6 aluminium metal for its
(continued)

5
Table 1. Continued.

6
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings

D. RIBEIRO ET AL.
strength, wear, lightweight, ease of
manufacturing & corrosion resistant
Outcome: Prosthetic hand manipulation
Zuniga et al. (2017) Objective: To manufacture an inexpensive 3DP Sample: N ¼ 1 (male); 7 years old; General findings:
Location: USA mechanical shoulder prosthesis to assist in Amputation type(s): Congenital shoulder  Weight of prosthetic was customized to replicate the weight or
Study: Qualitative performing bi-manual & unilateral activities disarticulation the other arm
Design: 3DP technology: Not described Patient history: Not described  This device can be used as a transitional device in preparation
Descriptive case study design Materials: PLA, ABS & Taulman Nylon Outcome: Prosthetic manipulation for a more sophisticated prosthesis
Software: Autodesk inventor  Improved technology could compensate for limitations
 Improved technology may compensate for the limitation of #
durability in lower cost devices
Advantages:
 # Cost
 Customization providing different infills & densities
 Correction in patient’s spinal deviation was noted due to
counterweight of the device
 " balance & performance after 2 weeks of using the device
Disadvantages:
 Was not effective for unilateral activities
 # Grip strength
 # Durability
Future studies:
 Improve upon 3DP technology
Yoshikawa et al. Objective: To create a realistic electric 3DP Sample: N ¼ 1 (male); 40 years old; General findings:
(2015) prosthetic hand Amputation type(s): Forearm amputation  Material cost USD $1250 while standard myoelectric prosthesis
Location: Japan 3DP Technology: 3D scanner Patient history: costs USD $15,000
Study: Qualitative Materials: Linear actuator, ABS resin  Right-handed  Non-contact distance sensors, so sweat does not affect the
Design: Descriptive case study design Software: CAD software Arduino Outcome: Prosthetic manipulation signal as well as the metal electrodes do not touch skin
Advantages:
 Person with amputation was able to grasp various objects &
perform various everyday activities
 MP hand gives the appearance of five fingers that are able to
grasp objects
 SHAP test illustrated that the amputee was able to grasp
various objects & perform everyday activities
 3DP to reduce costs, weight & provide ease of maintenance
Disadvantages:
 # Fine motor skills
 Could not pick up heavy objects
Future studies:
 To improve the stiffness of the hand & the size of the
control box
Ferreira et al. (2014) Objective: To create a passive prosthesis in a Sample: N ¼ 1 (male); 21 years old; General findings:
Location: Portugal 3DP silicone band Amputation type(s): Bilateral traumatic  5th finger is needed to properly grasp objects
Study: Qualitative 3DP technology: RP, Axial CT, SLA amputation of both hands  Prosthesis is fully made out of silicone closely matching to
Design: Descriptive case study design Materials: Silicone Patient history: patients skin colour & feeling of the finger
Software: CAD design  Due to accident of crushing both  Prosthesis is not only the fifth finger; it encompasses the palm
hands with a dumbbell, both as well to create suction between hand & prosthesis creating a
hands were amputated & more cosmetic appearance
re-implanted  3D manufacturing approach replaces traditional
 Post-re-implantation the fifth finger manual method
on left hand was fully amputated  Level of satisfaction was dependent on customization
due to necrosis of prosthesis
Advantages:
(continued)
Table 1. Continued.
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
Outcome: Prosthetic manipulation  Costs are # due to reduction in material used, "
& function manufacturing, accuracy & personalization
 # in patient visits
Disadvantages:
 Risk of infection &/or necrosis
 Obligatory use of prosthesis
 Need surgical intervention
Future studies: Not described
Hsu et al. (2010) Objective: To determine if resin layer wrapped Sample: N ¼ 1 (male); 59 years old General findings:
Location: China over a 2 mm-thick RP socket increases Amputation type(s): Unilateral left side  Compared to plaster model, the computer aided process could
Study: Qualitative socket strength & shortens RP fabrication TTA easily replicate previous devices that were scanned
Design: Descriptive case study design time, using less RP material Patient History:  Investigation measured interface pressures of an old socket, a
3DP technology: RP & FDM  31 yrs. experience using PTB polypropylene sheet socket & a handcrafted UPR socket
Materials: Polymer layer of polycarbonate, UPR. supracondylar prosthesis  All three sockets illustrated similar pressure distribution
Software: CAD/CAM  Able to walk without assistance compared to other sockets
 No cardiovascular or mental illness  Prosthetist & experienced CAD user is required
Outcome: Prosthetic fit Advantages:
 Computer aided process can easily produce a replica socket
Disadvantages:
 Study involves only one participant to date
Future Studies:
 To improve upon the strength of resin-reinforced RP sockets,
with a larger number of participants
Imanishi, J. & Choong, P. (2015) Objective: To determine whether 3DP Sample: N ¼ 1 (male); 71 years old; General findings:
Location: Australia calcaneus prosthesis is a viable alternative Amputation type(s): Calcaneus  Mirror image of left foot calcaneus was used to create a 3DP
Study: Qualitative to amputation Patient history: right foot calcaneus; Plaster cast; walker boot
Design: Descriptive case study design 3DP technology: EBM 3DP  History of heel pain  Allografts had high infection rates as well as prolonged
Materials: Titanium  Total calcanectomy followed by immobilization & weight bearing limitations
Software: CT scan prosthetic reconstruction  3DP prosthesis was less invasive & reduced time between
Outcome: Prosthetic fit designing & the actual surgery
 5 months after surgery the patient was free of pain
Advantages:
 Titanium is light, strong & biocompatible
 Less invasive without donor site problems
 Promotes earlier rehabilitation & discharge
Disadvantages:
 Report follow-up is short term, which might be too early to
draw any conclusions
Future studies: Not described
Webber, C. & Davis, B. (2015) Objective: To improve the design of the Sample: Not described General findings:
Location: USA prosthetic socket restoring a normal thermal Amputation type(s): Not described  Socket with the helical cooling channel showed greater

3D PRINTING AND AMPUTATION


Study: Qualitative environment around the residual limb Patient history: Not described temperature differences across the wall of the socket providing
Design: 3DP technology: AM Outcome: Prosthetic fit a cooling effect to the patients residual limb
Observational study design  Overall, the experiment indicated that heat from the inner
Materials: VeroWhitePlus opaque material surface of the socket was drawn to the cooling channel
Software: SolidWorks  VeroWhitePlus performed well & did not leak, warp or melt
during testing
 Socket type & location on the socket were factors affecting
temperature between inner & outer socket walls
Advantages:
 Max inner socket temperature reached 32.2  C, but with
cooling channel the inner temperature dropped slightly
(continued)

7
Table 1. Continued.

8
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings

D. RIBEIRO ET AL.
 Eight revolution helical cooling channels
Disadvantages:
 The experiment did not perform as well as expected possibly
due to experimental conditions & idealized
modelling conditions
 Thermal conductivity of the socket & the VeroWhitePlus
material may not have been the same, in turn affecting
the results
 Study only represents a short period of time where the patient
is active while using the prosthetic
 Liner in prosthetic was omitted from this study, therefore
affecting the true heat transfer assessment
Future studies:
 To investigate other materials that produce a balance of
thermal & mechanical properties, as well as improve design of
model sockets that are more representative of clinical
applications
Alvial et al. (2017) Objective: Impacts of using 3DP silicone- Sample: N ¼ 1 male; 51 years old General Findings:
Location: Chile embedded prostheses Amputation type(s): Partial hand Prosthesis 1: 3DP thumb & fifth finger embedded in silicone that
Study: Quantitative 3DP technology: CT scans proximal phalanx amputation is body powered by tension in metacarpophalangeal joint
Design: Descriptive case study Materials: PLA embedded in silicone Patient history: Prosthesis 2: 3DP PLA thimble shaped tools embedded in silicone
Software: CAD software  No comorbidities attached directly to stumps. Each tool had neodymium magnets
 Amputation on non-dominant (left) at the top
hand at different levels  The prosthesis (Prosthesis 2) that had neodymium magnets
Outcome: Object manipulation attached to each tool performed better than the prosthesis
(Prosthesis 1) that was body powered by tension in
metacarpophalangeal joint
Advantages:
 Prosthesis 2 was better when manipulating large &
small objects
 Prosthesis 2 was more useful as patient was able to complete
complex tasks
 Customizable & " production rate
Disadvantages:
 Short lifespan of silicone
 Silicone is not suitable for lifting heavy objects
 A multidisciplinary team is required (engineer, physician, etc.)
 Design technique is far from being automated
Future studies:
 To investigate solutions for all types of partial hand
amputations
Day, S. & Riley, S. (2017) Objective: To create & test a 3DP assistive Sample: N ¼ 1 (male) General findings:
Location: UK device to hold patients French horn Amputation type(s): Partial hand  Proved that 3DP can be an effective method for unique &
Study: Quantitative 3DP technology: FDM amputation of 5th digit at the custom made assistive devices
Design: Descriptive case study Materials: PLA metacarpophalangeal joint  It was possible to design & 3D print a device with limited
Software: Photogrammetry (123 catch Patient history: knowledge of the CAD software
software), & CAD  Amputation on left hand Advantages:
 Limited mobility in both hands due  Designing & fabricating 3DP device was 56% cheaper than a
to Dupuytren contractures laminated device
 Amputation due to unsuccessful  Easy to replicate casts
fasciotomy to release Dupuytren’s  Reduction in storage space as everything is digitally stored
contracture  Improved cosmesis
 Tried a variety of devices  Light weight
Outcome: Object manipulation Disadvantages:
(continued)
Table 1. Continued.
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
 Shape capture process is not very accurate
 There are no regulations to assess structural integrity of the
device prior to being given to the patient
Future studies:
 It was recommended that prosthetists be involved in the
designing & development of the device
Dally et al. (2015) Objective: To examine the performance Sample: N ¼ 40 (males & females) with General findings:
Location: USA characteristics of 3DP prosthesis for further no hand amputations  Participants assessed the hand’s range of abilities by
Study: Quantitative validation of appropriateness of this Amputation type(s): Hand amputation completing 14 tasks based on SHAP were completed
Design: Observational study design prosthesis for the developing world Patient history: Not described simulating an amputee bending his/her own wrist to
3DP technology: Additive manufacturing Outcome: Prosthetic hand manipulation grip objects
Materials: Thermoplastic  Tasks were completed by holding the gauntlet with one hand
Software: CAD & applying pressure to the back of the palm with the
other hand
 1=2 of participants used the larger adult sized prosthesis.
 The other 1=2 of participants used the smaller paediatric sized
prosthesis to evaluate effectiveness
 Larger prosthesis could pick up heavier objects while the
smaller hand could not
 Due to limitations, this prosthesis is not applicable for
amputees in low-resource settings
 Studies should be conducted with target audience; amputees
in the developing world to ensure the device can meet the
user’s needs in their day to day lives
Advantages:
 Prosthetic hand was able to pick up several objects, push & lift
objects, as well as turn pages
 Larger prosthesis had more success lifting heavy objects,
opening jar lids & turning door handles
Disadvantages:
 Rotating objects & pouring objects were difficult to perform
 Due to simple flexion in fingers, the device was not able to
tightly grip small objects
 Doors were difficult to open due to the weight of the door
 Majority of tasks showed mixed results as to whether the 3DP
prosthetic hand was beneficial
 Not applicable for persons with amputation in low-resource
settings due to the various limitations of the prosthesis
 Study was not conducted with the target audience
Future studies:
 The prosthesis needs to be able to perform a larger range of

3D PRINTING AND AMPUTATION


tasks & assess the usability of the device with individuals with
target audience
Lee et al. (2018) Objective: To assess functionality of 3DP Sample: N ¼ 1 (male); 67 years old General findings:
Location: Korea prosthetic Amputation type(s): Right thumb  Thumb had a nonslip pattern to prevent slippage of objects
Study: Quantitative 3DP technology: Artec 3D scanner amputation above  Prosthetic was designed as a band providing close attachment
Design: Descriptive case study design Materials: Fused flexible thermoplastic metacarpophalangeal joint to hand
elastomer filament (non-toxic), silicone & Patient history:  It took 48 h to produce, at a cost of US $50
acrylic  Amputation occurred in 1970  Finger prosthesis was specifically shaped
Software: Geomagic Freeform  Had gait difficulties with ataxia Advantages:
 Mild right hand weakness due to  Patient adapted easily to prosthesis
left anterior inferior cerebral  Test scores improved after prosthetic fitting from BBT score
infraction in 1999 of 17–21
 Jebsen-Taylor hand function test  Faster, cheaper than conventional prosthesis
& BBT

9
(continued)
Table 1. Continued.

10
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
 

D. RIBEIRO ET AL.
Right & left hand was scanned Patient gave a QUEST of 36 out of 40 points, being very/quite
with 3D scanner at 16 frames/s; satisfied with the prosthesis
Left thumb flipped to create  3D image files can be easily modified
right thumb Disadvantages:
Outcome: Prosthetic hand manipulation  Inability to stack objects due to the angle of the
prosthetic thumb
Future studies:
 To adjust the angle of the thumb to ease stacking of objects
for the patient
Xu et al. (2017) Objective: Design & manufacturea 3DP Sample: N ¼ 1 (male); 8 years old General findings:
Location: China prosthetic hand Amputation type(s): Wrist amputation  During 3-month follow-up patient was satisfied with prosthesis
Study: Quantitative 3DP technology: Open-sourced design Patient history:  No complications were reported by patient & their family
Design: Descriptive case study design (thingsiverse.com)  Amputation on right wrist Advantages:
Materials: ABS filament  Diagnosed with MESS  UNB test of prosthetic function for unilateral amputees skill
Software: Slic3r  No comorbidities score increased over the course of 3 months
Outcome: Prosthetic hand manipulation  Child could function & perform daily activities
& function  Low-cost (<$20)
 Easy customization
Disadvantages:
 Open-source designs are not regulated
 3DP prosthesis did not function properly in certain
bimanual movements
Future studies:
 Future studies should assess possible disadvantages of 3DP
prosthetics & compare them to traditional methods of
making prostheses
Zuniga et al. (2015) Objective: To find a low-cost 3DP prosthetic Sample: N ¼ 11 children (two girls & General findings:
Location: USA hand & propose a fitting methodology seven boys); 3–16 years old  Children used their prosthetic for fun, activities at home, to
Study: Quantitative 3DP technology: Makerbot Printer Amputation type(s): Upper-limb play, for school & for sports
Design: Observational study design Materials: PLA & ABS amputations (one traumatic & eight  This prosthetic hand is a viable option for children in
Software: Blender 7.2 congenital) developing countries & those with little access to health
Patient history: care providers
 Nine used the prosthetic for 1–2 h/ Advantages:
day; three used the hand more  3DP prosthetic hand is low-cost, light weight, easy to use, easy
than 2 h/day; one used hand only fitting, easy assembly & appealing to children
when needed  All subjects reported an increase in quality of life (four were
 All families & children completed a significant & seven were small & one no change)
survey about quality of life, daily  Surveys indicate that this 3DP prosthesis may positively impact
usage & activities performed after patient quality of life
a 1–3 months of using Disadvantages:
the prosthetic  Inaccurate scaling could affect function or fitting of
Outcome: Prosthetic hand manipulation the prosthesis
& function Future studies:
 To investigate functionality, validity, durability & benefit/
rejection rate of 3DP prosthesis
Zuniga et al. (2016) Objective: To identify anthropometric, active Sample: N ¼ 5 (two girls & three boys); General findings:
Location: USA range of motion & strength changes after 6 3–10 years old  First visit: Fitting procedures & anthropometric measurements
Study: Quantitative months of using a wrist driven 3DP Amputation type(s): Upper limb were taken
Design: Observational study design transitional prosthetic hand for children amputation  Second visit: Six months after using the prosthesis patients
with upper limb deficiencies Patient history: repeated all measurements performed during first visit
3DP technology: Makerbot  One traumatic & four congenital  Wrist flexion & extension strength was measured for
Materials: PLA & ABS  Unilateral carpus upper both hands
Software: Blender software limb reductions  Average time to print & assemble the prosthesis was 4–7 h
 Wrist active range of motion  Prosthesis can be used for activities involving manipulation of
greater than 20˚ light objects
(continued)
Table 1. Continued.
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
Outcome: Prosthetic hand manipulation  Individuals in developing countries are not being treated with
& function prosthetics due to the lack of trained technicians & lack
of tools
 A licensed prosthetist with a 3D printer could provide 3DP
prosthetics to patients around the world at a very low cost
 3DP is in its early stages & requires a certified prosthetist for
proper development
Advantages:
 There were slight increases in strength, flexion, extension &
range of motion after wearing the 3DP prosthesis for 6 months
 Increase in circumference & wrist range of motion suggests
that 3DP prosthesis is an effective transitional/initial device for
children with traumatic & congenital upper limb deficiencies
Disadvantages:
 Environmental factors (temperature) have to be taken into
consideration when building the prosthetics as three out of the
fivechildren reported breaking or malfunctioning
3DP prosthetic
 There are no standards for manufacturing 3DP prosthetics
which makes it difficult to obtain reliable print
Future studies:
 To examine functionality, durability, safety & 3DP standards for
prosthetic devices
South et al. (2010) Objective: To use SLS to prosthetic feet with Sample: N ¼ 1; 45 years old General findings:
Location: USA varying stiffness & its influence on gait Amputation type(s): TTA  SLS prosthetic produced a similar stiffness characteristic as the
Study: Quantitative 3DP technology: SLS Patient history: carbon fibre foot
Design: Descriptive case study design Materials: Nylon, carbon fibre  Traumatic, unilateral amputee for  Kinematic gait & kinetic characteristics were the same
Software: CAD software over 16 years  Mechanical testing verified that the SLS prosthetic performed
 Proficient walker similarly to the carbon fibre prosthetic
 In good physical condition  There were only minor differences in ankle & knee moments
 No musculoskeletal disorders & angles
or pain Advantages:
Outcome: Prosthetic foot manipulation  SLS did not fail or leave any permanent damage when inflicted
& function with high loads
 Versatility of SLS allows for easy scaling

Disadvantages:
 There is also a lack of information available regarding response
of SLS feet to impact loading
 Long-term fatigue characteristics were not assessed

3D PRINTING AND AMPUTATION


Future studies:
 To modify the foot design to reduce ankle & knee moments
during midstance
Duong et al. (2017) Objective: To test & compare efficiency & Sample: N ¼ 24 (14 men & 10 women); General findings:
Location: USA functionality of 3DP & MP hand 22–30 years old  BBT was used to assess efficiency of prosthetic hand
Study: Quantitative 3DP technology: MakerBot Replicator 2 Amputation type(s): Not described  BBT using Limbitless Arm then 2 weeks later took BBT using
Design: Cross-over randomized trial Materials: Polypropylene plastic, PLA & TPE Patient history: i-limb
Software: Not described  Healthy.  Two trials were completed
 Right hand dominant  With better development & technological advancements 3DP
 Completion of BBT with Limbitless can be a viable option in the future
Arm & i-limb  Despite the weight of the device the size & shape of the i-limb
Outcome: Prosthetic function was more compatible to the female body influencing
performance
(continued)

11
Table 1. Continued.

12
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings

D. RIBEIRO ET AL.
i-Limb
 MP hand
 Digits are motorized independently
 One sensor was placed at proximal anterior part of forearm
 One sensor was used to produce a similar function to the
Limbitless Arm
 Used EMG signal
Limbitless Arm
 First 3D printed MP hand
 Uses an Arduino microcontroller, muscle sensors, lithium
polymer batteries, etc.
 Three electrodes were placed on flexor muscles
 Used EMG signal
Advantages:
 The number of blocks successfully transferred by the i-Limb
improved by 53.57% in the first trial & 66.27% in the
second trial
 i- Limb was more efficient & practical
 The difference in the number of blocks moved for trial 2 was
more significant for women than men
 25% of participants reported that the i-limb was heavier than
the Limbitless Arm
Disadvantages:
 Fatigue due to weight
 Sensors did not accurately detect the muscle contractions
 Limbitless Arm used disposable sensors, so they had to change
every time the prosthesis was taken off & had to be placed
back on the arm accurately otherwise the arm will not move
 Joints of Limbitless Arm were limp & lacked rigidity which
affected the individual when grasping objects
 Used a one-size-fits all prosthetic measurement, which had
drawbacks, such as it was too big, & bulky causing pain
Future studies:
 To compare both prosthetic hands on patients with hand
amputations to fully understand functionality of the prosthetic
Tao et al. (2016) Objective: To create a new design process Sample: 240 (120 males & 120 females); General findings:
Location: Korea using topology optimization methods to 25–30 years old  Light weight prosthesis mimicking the natural limb is more
Study: Quantitative develop a new prosthetic foot Amputation type(s): LLA comfortable as well as it reduces stress on the remaining
Design: Observational study design 3DP technology: FDM Patient history: musculature of the patient
Materials: PLA  Ankle height of 80 mm  PLA is lightweight, easy machining, & environmental protection
Software: CAD Outcome: Prosthetic function as it is derived from renewable resources
 Smooth outer surface & rough inner surface (smooth for
aesthetics & rough is insignificant)
 62% weight reduction
 While weight is reduced the structure is maintained
 Safety of this prosthetic was validated using the finite element
analysis using a strain gauge test
Advantages:
 Customization
 Capacity to share designs
 Outsource manufacturing
 Speed & ease of manufacturing
Disadvantages:
 Limited material choice available providing proper structural
support for this model
(continued)
Table 1. Continued.
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
Future studies: Not described
Laszczak et al. (2015) Objective: Sample: Not described General findings:
Location: UK To design a sensor to monitor mechanical Amputation type(s): Lower limb  Interfacial stress sensor that has a Flexible sensor frame that
Study: Quantitative stresses at the stump- socket interface Patient History: Not described could potentially accommodate bespoke surface shapes
Design: Observational study design 3DP technology: RP Outcome: Prosthetic fit  TangoBlack has a strain range from 30% to 50% with a stress
Materials: Elastomeric TangoBlack material region of 0.95–0.80 MPa
Software: CAD/CAM  Sensor measures pressure & shear stress up to 350 & 80 kPa
 Sensor demonstrated high linearity (5–8%), high pressure
(1.3 kPa) & shear stress (0.6 kPa) performance
 Pressure of 8 kPa has been shown to cause soft tissue ischemia
reducing blood flux
 Fit, design & comfort of prosthesis is a major issue for persons
with lower limb amputation
 Poor fit results in deterioration of skin & underlying soft tissues
possibly leading to a stump ulcer
Advantages:
 Low-cost versatile solution
 Sensor is a viable tool to evaluate prosthetic socket fitting
preventing stump tissue breakdown
 3DP allows the sensor to be flexible, easy to scale, lightweight
& can be fabricated in many shapes
 RP elastomers provide low-cost manufacturing & potential
improved functionality in clinical applications
Disadvantages:
 Sensors were limited to quasi-static behaviour
Future studies:
 To estimate fatigue to evaluate sensor lifetime
Rogers et al. (2000) Objective: To test the feasibility of using SLS Sample: N ¼ 1 (male); 65 years old General findings:
Location: USA to fabricate a prosthetic socket Amputation type(s): TTA  Monolithic, flexible-double-walled socket
Study: Quantitative 3DP technology: SLS, CAD Patient history:  SLS was acceptable for clinical testing
Design: Descriptive case study design Materials: Nylon  Healthy & mature residual limb  Long-term durability & structural integrity need to be tested
Software: ShapeMaker CAD  Limited community level  This weight was due to the material used, as well as the added
Outcome: Prosthetic fit& function material at regions that endure higher stress
 SLS socket was 450 grams heavier than the conventional
socket (due to material used) however the weight difference
was not very noticeable by the subject
 Joint kinetics & moments did not illustrate large differences

3D PRINTING AND AMPUTATION


between the 3DP & conventional prosthesis
 No software tools available for prosthetists to design sockets in
a shorter period of time
Advantages:
 Socket comfort was 10% higher for the SLS socket
 Small improvements were noted in walking speed &
step length
Disadvantages:
 3DP nylon socket was heavier than the conventional socket
made out of carbon fibre
 SLS computer design requires a high level of engineering
expertise & can be time intensive
(continued)

13
14
Table 1. Continued.

D. RIBEIRO ET AL.
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
 SLS resulted in a less cosmetic appearance
Future studies:
 To investigate long term clinical evaluations of patients
involving larger trials
Rogers et al. (2008) Objective: To assess performance of sockets Sample: N ¼ 1 (male); 47 years old General findings:
Location: USA with compliant features to relieve in-socket Amputation type(s): TTA  In-socket pressure was measured
Study: Quantitative pressure for TTA Patient history: Not described  Less pressure over distal tibia & fibula head than the
Design: Descriptive case study design 3DP technology: SLS, scanner Outcome: Prosthetic fit conventional socket
Materials: Rilsan D80 polyamide powder (Nylon  Both sockets were geometrically identical except for
11) compliant areas
Software: GordoDesign prosthetic CAD Advantages:
software, & ShapeMaker 2000  3DP prosthetic sockets were successful in reducing pressure in
sensitive areas of the residual limb
 Comfortable
Disadvantages:
 Difference in material may contribute to in-socket pressure
differences
 In socket sensors were affected by the curvature of the socket,
reporting higher pressures in higher curvature areas
 Socket is unattractive
Future studies:
 To improve upon long term durability of sockets, cosmetic
appearance & increase number of participants in trials
Sanders et al. (2016) Objective: To design & fabricate custom plastic Sample: Not described General findings:
Location: USA inserts for transtibial prosthesis users Amputation type(s): TTA  Subjects wore sockets with inserts for 4 weeks
Study: Quantitative 3DP technology: AM Patient history: Not described  Shape of insert was evaluated
Design: Observational study design Materials: VeroBlue RGD840 rigid opaque Outcome: Prosthetic fit  100 min for scanning & designing the insert
polymer  Each of the three insert sections took 6–13 h to fabricate
Software: CAD/CAM, FaroArm Platinum Scanner  Insert shape changes can be digitally tracked to monitor
limb maturation
Advantages:
 Insert shape quality improved after being worn by amputee &
was highly accurate
 Low-cost
 After 4 weeks inserts averaged less than 0.09% volume
difference compared to designed shape
Disadvantages:
 Design software needs to be enhanced to include solid model
generation & manipulation
Future studies:
 To investigate impact of socket shape changes, comfort &
gait features
Freeman, D. & Wontorcik, L. (1998) Objective: To manufacture a prosthetic test Sample: N ¼ 1 General findings:
Location: USA socket using SLA & dynamically align it on Amputation type(s): TTA  Plaster Mold; Digitize Mold; 3DP; Cure by laser (80%) & then by
Study: Quantitative a patient Patient history: Not described UV oven (20%)
Design: Descriptive case study design 3DP technology: SLA Outcome: Prosthetic fit & function  First test Socket¼$3480 with a build time of 58 h
Materials: Photopolymer epoxy resins  Second Test Socket ¼$1560 with a build time of 26 h
Software: CAD  First Test Socket had 0.0625 grooves due to errors in
file conversion
(continued)
Table 1. Continued.
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings
 Socket comfort & fit were similar to sockets made out of co-
polyester via the traditional method
 Photopolymer was strong enough to support the 170 lb
patient during ambulation for 1 h
 Photopolymer is semi-transparent allowing the prosthetist to
view the liner through the socket wall
 SLA eliminates the need for a positive mould
 As new material properties & SLA machining speeds increase,
3DP may become a cost-effective method of manufacturing
prosthetics in the orthotic & prosthetic industry
Advantages:
 Second Test Socket build time decreased by 50% due to the
elimination of the grooves in the socket wall & addition of
photopolymer resin
Disadvantages:
 Time
 Cost
Future studies:
 To reduce production time & cost
Ramakrishnan et al. (2017) Objective: To compare gait of subject using Sample: N ¼ 1 (female); 37 years old General findings:
Location: UK existing Ossur Total Knee 2000 & 3DP Amputation type(s): High functioning  Experiment was conducted using a CAREN to capture motion
Study: Quantitative prosthetic knee transfemoral amputation of leg
Design: Descriptive case study design 3DP technology: Not described Patient history: Not described  Subjected walked on treadmill for 10 m
Materials: Carbon-fibre & nylon Outcome: Prosthetic fit & function  Overall, 3DP is a viable option for prosthetic fabrication
Software: Not described Ossur Total Knee
 Uses hydraulic system to excess flexion assisting in forward
swing of leg
 Human-like gait
 Heavy, costly, cannot personalize, requires maintenance
 More asymmetric gait
3DP Prosthetic
 Subject was forced to use other muscles to support her as she
walked because she was waiting for the terminal impact of
the knee
Advantages:
 Cheap, lightweight
 Higher peak flexion due to lower resistance
 Allows for customization for patient

3D PRINTING AND AMPUTATION


 More symmetric gait resulting in a more comfortable &
stable gait
Disadvantages:
 Materials used for 3DP do not have the same strength as
moulded plastics
Future studies:
 To examine a less straining prosthetic for the user while
preserving symmetric gait
Zang et al. (2017) Objective: To report pre-operative planning Sample: N ¼ 5 (four male & one General findings:
Location: China using 3DP to plan thumb reconstructions female); 16–45 years old  Rehab; Thumb was reconstructed using mirror technology; 3DP
with second toe transplant Amputation type(s): Middle of proximal bone & joint of thumb & 2nd donor toe; Surgery where flap of
(continued)

15
Table 1. Continued.

16
Study objective, 3D printing technology
Study (location & design) & materials Clinical characteristics & outcome(s) Main findings

D. RIBEIRO ET AL.
Study: Quantitative 3D printing technology: CT machine phalanx (one case) & Basilar part big toe & bone of second toe were harvested from the donor
Design: Observational study design Materials: PLA proximal phalanx (four cases) & re-implanted on donors thumb; 3DP bone goes into the
Software: CT scans & Boholo surgical Patient history: thumb & 3DP joint goes in 2nd toe; An iliac artery flap & bone
simulator software  Two cases of machine crush injury were also used to rebuild the donor foot
 Two cases heavy crush injury  The interphalangeal joint of the second toe & bone of the big
 One caserotated & avulsed injury toe under its nail bed were used as donors for the thumb
 Right thumb defects in three cases  All thumb reconstructions were successful
 Left thumb defects in two cases  3D printing of bone & joint are good choices for achieving
 Four cases of injury on dominant thumb reconstructions
side & one case of injury on non-  3DP technology will play an important role in hand
dominant side reconstruction surgery
 Three patients had thumb stumps Advantages:
with moderate stenosis of first web  3–15 months after implantation, all patients were satisfied
Outcome: Prosthetic fit & function  Function & appearance had a success rate of 100%
 3DP is fast, shortening surgical time
Disadvantages:
 Cannot 3D print the whole thumb due to biomechanical
mismatches, cosmetic reasons & reduced flexibility
Future studies:
 Continuing to improve & develop 3DP technology
3DP, three dimensional printing; ABS, acrylonitrile butadiene styrene; AM, additive manufacturing; BBT, box and block test; CAD, computer aided design; CAM, computer aided manufacturing; CAREN, computer-assisted
rehabilitation environment; CT, computerized tomography; EMG, electromyography; FDM, fused filament fabrication; kPA, kilopascal; lbs, pounds; LLA, lower limb amputation; MHz, megahertz; Mm, millimeter; MP, myo-
electric prosthesis; MPa, megapascal; PLA, polylactic acid; PSP, pressure-sensored prosthetics; QUEST, quebec user evaluation of satisfaction with assistive technology; RF, radio frequency; RGD, arginylglycylaspartic acid;
RP, rapid prototyping; Sec, seconds; SHAP, Southampton hand assessment procedure; SLA, stereolithography; SLS, selective laser sintering; TPE, thermoplastic elastomer; TRA, transradial amputation; TTA, transtibial
amputation; UNB, University of New Brunswick; UV, ultraviolet.
3D PRINTING AND AMPUTATION 17

Records idenfied Records idenfied

Idenficaon
through database through other sources
searching (n = 8)
(n = 177)

Records aer duplicates removed


(n = 119 + 8)
Screening

Records screened Records excluded


(n = 119 + 8) (n = 77)
Eligibility

Full-text arcles Full-text arcles


assessed for eligibility excluded, with reasons
(n = 42 + 8) (n = 22)
Review paper, Abstract,
Poster, No 3D prinng
involved, Animal trial,
not peer reviewed
Studies included in
qualitave synthesis
Included

(n = 28)

Figure 1. PRISMA diagram [45].

outcome measures of function, which makes comparisons across restoration of function [42]. Patients get fitted with their pros-
studies difficult. thetic in a shorter period of time compared to traditional pros-
thetics and can start rehabilitation earlier preventing further
deterioration and loss of muscle strength. By starting rehabilita-
Discussion
tion at an earlier time, patients are more likely to get discharged
The purpose of the present scoping review was to map the litera- from the hospital at an earlier date, which is not only beneficial
ture on 3D printing and its applications in the field of amputation, for the patient but also for the hospital as beds become open to
which demonstrated that the current state of knowledge is lim- accommodate more patients [44]. Several of the identified studies
ited. Only 28 studies were identified for this review, and most had showcased the rapidness of the fitting and manufacturing proc-
a small sample size with no direct comparison to traditional cast- esses associated with 3D printing [4,30,34–36,39–41].
ing methods. The number of studies were somewhat evenly split Currently, there is a diverse range of materials available for use
between lower limb and upper limb amputations; with the major- with 3D printers when compared to traditional casting methods,
ity of the upper limb studies being focused on hand prosthetics. each varying in mechanical strength, flexibility and biocompatibil-
Although several studies were using CAD (on its own or in tan- ity [5]. Each material, however, has a limit as to how much stress
dem with another program) and used PLA or ABS as materials, and strain can be exerted on the prosthetic. Materials with higher
the approaches, technologies and materials to fabricate 3D stress and strain limits are primarily used for lower limb pros-
printed devices were quite diverse. The main findings of this thetics, as they need to provide more support for the individual
review indicate there is great potential in the application of 3D to allow weight bearing. The material used to fabricate the device
printing in the prosthetics and rehabilitation industry but further has an impact on the weight of the product [12]. As a result,
work is need to improve the capability of the technology, stand- most of the studies in the review noted that 3D printing produces
ardize approaches and improve methodological robustness lightweight devices [20,25,26,28,30–32,34,38,42]. The included
of studies. studies in this review used a wide variety of materials, but with
the most commonly used were many PLA and ABS plastics.
Plastics are known to be lightweight as a result of their many
Advantages of 3D printing
polymer chains consisting of carbon, oxygen, nitrogen and sul-
The ease of scanning, designing, printing and fitting a prosthetic phur atoms [45]. In producing 3D printed devices that are lighter
within days is beneficial in clinical practice promoting earlier in weight compared to other devices, individuals using these
rehabilitation, reduced hospital length of stay and quicker devices are more likely to perform daily activities with greater
18 D. RIBEIRO ET AL.

ease and balance and posture are improved as a result of a Cosmetic appearance was another quality that many partici-
lighter prosthesis [28]. Furthermore, light weight prostheses are pants found unfavourable due to the uncomfortable mechanical
more comfortable for those with a lower limb amputation, as it feeling and appearance [18,21,22,34,39]. Many prosthetic devices
reduces the strain placed on the musculature [36]. Conversely, are constructed out of materials that do not physically and textur-
heavier prosthetics can negatively affect users by causing more ally resemble a human appendage. This can be a major concern
muscle fatigue [18]. for lower limb and upper limb prosthesis, as lower limb prosthe-
Lightweight devices are also a result of the way the 3D printer ses have limited materials available that would provide enough
was set up and their thickness and infill settings, as smaller thick- structural support that is required for weight bearing [37]. In hav-
nesses, infills and densities result in less material used and there- ing limited materials available, the cosmetic appearances of these
fore a lighter device [28]. 3D printing not only uses less material prostheses are reduced as a result. Lower limb prostheses can be
but it also reduces the amount of material wasted contributing to covered up by clothing and footwear, whereas upper limb pros-
a reduction in material costs as well as manufacturing costs since theses are more visible to others. Although upper limb prostheses
less labour is required [31,41]. This decrease in cost is a major have a larger variety of materials available, they still look and feel
advantage associated with this technology, as these prosthetic mechanical affecting self-esteem and body image [34]. The issue
devices are more affordable to individuals with lower income of appearance is a major concern for some individuals, and
[20,26,27]. This was illustrated in a majority of the articles although there are some material alternatives that resemble a
screened revealing financial feasibility among a wide array of par- more natural human appendage, they are more expensive and
ticipants [20,23,26,28,30–32,34,35,37,38,41]. Traditional custom- time and labour intensive to produce [6].
made prosthetics on the other hand can be very costly imposing In 3D printing, the designing software can become problem-
financial burden on the person with the amputation and their atic for novice users. Although, designing on CAD software can
family [26]. This can be especially detrimental if the amputation be relatively easy when creating simple products, when designing
arises from a congenital condition or is sustained early in life, prosthetics of certain dimensions, this process can be time inten-
which necessitates the growing child to be re-fitted for a pros- sive and complicated. For instance, Rogers et al. commented that
thetic every couple of years [26]. 3D printing has the potential to computer designs for 3D printed devices requires a higher level
of engineering expertise, therefore, an experienced CAD software
reduce the costs associated with the manufacturing of the pros-
designer must be readily available to create such intricate designs
thetic, as well as extra parts can be printed within hours to
[22]. If an experienced CAD software designer is inaccessible, less
accommodate growth in a youth with an amputation [26].
customized 3D model files can be accessed and downloaded for
Customization of these devices is another advantage of 3D
free online. Although these open-source designs seem like a
printing, as all prosthetic 3D scans are stored digitally with all of
favourable alternative to designing products manually, they are a
the patient’s measurements. These digital scans can be modified
major concern with this new technology, as designs uploaded are
with ease at any moment and be printed within days [4,30,34,35].
not regulated [26,27].
In storing these devices digitally, there is a decrease in devices that
According to Day and Riley [30] regulations assessing structural
need to be placed in a storage space for reference [30].
integrity of 3D printed devices including fatigue levels and weight
Customization of this device promotes a more accurate representa-
bearing stress have not yet been developed [24,34]. This poses as
tion of the amputated area, allowing the device to fit more com-
a significant problem in the future as devices could malfunction
fortably [25,34]. These advantages also have physical and in use and have negative repercussions. Therefore, 3D printing of
psychological effects for the end-users. For instance, an included prosthetics requires more research and technological advance-
study by Zuniga and colleagues [26] reported that almost all their ments in order to produce a more sustainable alternative to trad-
subjects demonstrated an increase in their quality of life due to itional prosthetics.
low cost, light weight, customizable 3D printed devices.

Recommendations for research


Disadvantages of 3D printing
Due to the lack of literature available on 3D printing and amputa-
Despite the many benefits of this technology, 3D printing is still tion, it is difficult to extrapolate definite sources of evidence for
in its infancy requiring much advancement to gain acceptance in its superiority compared to traditional casting methods. The
the medical industry. Upon further analysis of the 28 articles (see majority of the studies were completed using only a 3D printer
Table 1), many of the noted drawbacks associated with 3D print- and primarily reported on patient satisfaction with the device cre-
ing included inferior grip strength, dexterity and durability for ated. A significant issue in terms of the studies was the small
upper limb prostheses. The human hand has 27 degrees of free- sample sizes, with more than half being a case study with a single
dom, while a 3D printed hand only has up to 6 degrees of free- individual. As a result, it is difficult to produce concise unbiased
dom [17]. This reduction in mobility can affect the overall perspectives as to whether 3D printed devices are more comfort-
functionality of the prosthesis and the activities that can be per- able, functional and more cosmetically appealing for patients. It is
formed. Many of the articles found that this reduction in function- recommended that additional trials and studies regarding the
ality and the negative psychological and physical consequences it topic of 3D printing and amputation be conducted in comparison
had on the patient’s everyday life [17,25,33]. Fine motor skills are to traditional casting methods, as well as include a larger experi-
also affected restricting hand rotation, the ability to pick up small mental sample size that are applicable to the study. In doing so,
items or heavy items and performing everyday tasks such as but- more data can be compiled and analyzed to evaluate which
toning a shirt [36]. For those who had a lower-limb amputation, method (3D printing or traditional casting) is superior. It is also
struggles with fit, design and comfort of the prosthesis were recommended that prosthetists should be present during the
noted to be a major issue [31]. These issues with fit can ultimately development and implementation of the prosthetic to ensure
result in compromised viability of the skin and soft tissue, leading proper fit on the patient, as the 3D printing technology is not yet
potentially to pressure ulcers [31]. capable of automating such a process [40]. This is one of many
3D PRINTING AND AMPUTATION 19

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Disclosure statement
[20] Gretsch KF, Lather HD, Peddada KV, et al. Development of
No potential conflict of interest was reported by the authors. novel 3D-printed robotic prosthetic for transradial ampu-
tees. Prosthet Orthot Int. 2016;40:400–403.
[21] Rogers B, Bosker G, Faustini M, et al. Case report: variably
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