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State of the Art

New and evolving technologies for knee


arthroplasty—computer navigation and robotics:
state of the art
Francisco Figueroa,1,2 David Parker,3 Brett Fritsch,3 Sam Oussedik4
1
Orthopaedic Surgery, Hospital Abstract
Sotero del Rio, Santiago, Chile Key articles on computer-assisted surgery 
2 Computer-assisted navigation was introduced as
Orthopaedic Surgery, Clinica
an adjunct to total knee arthroplasty (TKA) with the (CAS) total knee arthroplasty (TKA)
Alemana - Universidad del
Desarrollo, Santiago, Chile potential of improving positioning and alignment of TKA
1. Delp et al11 reported the first series of CAS TKA
3
Orthopaedic Surgery, Sydney implants. Computer-assisted surgery (CAS) can be divided
Orthopaedic Research Institute, in 1998.
into: passive (navigated TKA) or semiactive and active
Sydney, New South Wales, 2. Harvie et al36 published the results using a
Australia
(robotic TKA). Passive CAS has shown improved results
surface-mounted CAS system.
4
Orthopaedic Surgery, University regarding alignment in TKA compared with conventional
3. Mayman16 made a comprehensive review on
College London Hospitals NHS instrumentation but it has several possible complications
Foundation Trust, London, UK handheld CAS TKA.
such as registration errors, pin site complications, increased
4. Gustke42 reported the first results using a
surgical time and a potentially longer learning curve.
Correspondence to pressure-sensor in TKA.
Robotic TKA has been developed to eliminate the possible
Dr Francisco Figueroa, Hospital 5. de Steiger et al14 demonstrated a clinical
Sotero del Rio, Santiago, Chile;
error in the preparation of bone surfaces by the surgeon.
benefit in CAS TKA in patients younger than
​franciscofigueroab@​gmail.​com There is still little evidence on these systems but the early
65 years old.
results are encouraging. Despite better results in accuracy
Received 15 August 2017 6. Siebert et al51 reported the first series of
with both CAS systems, clinical benefits are still subject of
Revised 29 October 2017 robotic TKA in 2002.
debate. Additional research is required to fully define the
Accepted 29 November 2017 7. van der list et al28 did a systematic review on
Published Online First costs and benefits of robotics in regular medical practice.
CAS navigated and robotic TKA.
23 January 2018
8. Jacofsky et al48 published a comprehensive
review on history and evolution of robotics in
Introduction arthroplasty.
For patients with disabling knee osteoarthritis, 9. Gholson et al45 reported on current rates of
total knee arthroplasty (TKA) is widely considered adoption and complications on CAS TKA in
a successful management option.1 Following TKA, USA.
most patients can expect long-term reduction in 10. The Australian Orthopaedic Association
pain and improvements in quality of life,2 3 and National Joint Replacement Registry70 is an
between 72% and 86% of patients report that they obligated source of data in navigation surgery
are satisfied with their postoperative outcome.4–6 adoption rates and outcomes.
The stepwise improvements in implant tech-
nology and surgical technique have contributed
to broad success with TKA, though there remains The first computer-assisted knee replacement
a significant proportion who do not achieve their was performed almost 20 years ago.11–13 Computer-
desired outcome. The introduction of newer TKA assisted navigation was introduced as an adjunct to
designs has been largely unsuccessful in improving TKA surgery with the potential to improve posi-
functional outcomes, particularly among the highly tioning and alignment of the TKA prostheses.1
active, younger and higher demand patients.7 Despite numerous publications providing
In a recent study of more than 60 000 revision supporting evidence of the advantages of this tech-
TKA in the USA, infection was identified as the nology over conventional instrumentation, knee
leading cause of revision (25.2%), followed by arthroplasty navigation has yet to become main-
mechanical loosening (16.1%) and implant failure/ stream.14 Several reasons have been cited, including
breakage (9.7%).8 The most important predictors cost, learning curve, additional incisions for pin
of failure secondary to prosthesis loosening are sites, increased operating room time, technical diffi-
poor positioning of the prosthesis and subsequent culty and lack of evidence that clinical outcomes are
malalignment of the postoperative lower limb.1 A improved.15 16
meta-analysis found that as little as 3° of deviation This review will focus on the use of computer-
from mechanical alignment in the coronal plane assisted surgery (CAS) in knee arthroplasty and will
significantly increased the risk of TKA failure.9 cover the different types of CAS including naviga-
Varus malalignment can lead to increased stress on tion and robotic surgery.
the bone of the medial tibial plateau and accelerated
failure.10 Avoidance of malalignment through strat-
To cite: Figueroa F, Parker D, egies that increase the accuracy of prosthesis posi- Types of CAS
Fritsch B, et al. JISAKOS tioning may improve long-term prosthesis survival CAS systems are classified into three main
2018;3:46–54. rates for patients. categories:13
46 Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146. Copyright © 2018 ISAKOS
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State of the Art


additional radiation, cost and planning associated with
preoperative CT scans.17 This is the most common form of
navigation in use for knee arthroplasty.

Passive CAS: navigated TKA


Accuracy of implant positioning
Navigation has been shown to reliably increase accuracy of align-
ment parameters. Residents’ ability to accurately place cutting
blocks for TKA in a plastic saw-bone knee model has been
studied, demonstrating alignment closer to a neutral mechan-
ical axis using navigation, therefore improving reproducibility in
inexperienced surgeons.18
In a randomised study, Zhang et al19 demonstrated that 28%
of conventional TKAs had mechanical axis deviation larger
than 3° , whereas none of the navigated knees were misaligned
by these criteria. Blakeney et al,20 Tolk et al,21 Cip et al22 and
Todesca et al23 supported these findings with studies suggesting
Figure 1  Process of anatomical landmarks registration. that CAS had fewer outliers than conventional TKA (table 1).
Thienpont et al24 aggregated the results of 10 meta-analyses
(comprising 239 studies, 118 of them randomised controlled
►► Passive: the system assists the procedure under the direct
trials) and were able to compare the results for 28 763 patients
control of the surgeon. For example, CAS is used to posi-
who had undergone either conventional or computer-assisted
tion the cutting blocks in the exact desired position, but the
navigational arthroplasty. The authors found that there was
surgeon uses conventional instruments to make the bone
a significantly lower likelihood of mechanical axis outliers
cuts. Navigation is part of this category.
(defined as more than 2°) when computer-assisted navigation
►► Semiactive: are controlled robotic tools where the system
was compared with conventional arthroplasty (OR from 0.21
restricts a task within a predetermined frame. In other
to 0.76).
words, it is an enforced controlled robot.
►► Active: are robotic tools performing surgical tasks such as
drilling or milling without the direct intervention of the Clinical outcomes
surgeon. While the majority of studies have indicated that computer-as-
­ sisted navigation improves alignment, controversy remains as to
Two different modalities are also available for these systems:13 whether this leads to any additional clinical benefit.
►► Image-based modality: this modality consists of three-di- In a prospective randomised trial, Huang et al25 showed a
mensional constructs created using images obtained from mechanical axis within 3° of neutral in more CAS TKAs than
preoperative CT or MRI. conventional ones and that at 5 years there was a positive
►► Image-free modality: This technology does not require any correlation between alignment and better International Knee
imaging. The patient’s anatomical landmarks are collected Society and SF-12 scores.
directly during surgery (figure 1) to create the patient-spe- In a meta-analysis of 21 studies involving 1713 knees that
cific model. This modality is the one most commonly used in were treated with either computer-assisted (n=869) or conven-
knee surgery. When using these systems, the surgeon obtains tional (n=844) arthroplasty, Rebal et al26 found that, in addition
anatomical registration points intraoperatively, which are to improving alignment, computer-assisted navigation was asso-
then used to create a 3D knee model based on a database of ciated with significantly greater increases in Knee Society Scores
knee CT scans (figure 2). The knee position and cutting jig at both 3 and 12 months postoperatively.
are then positioned according to the reference frame created A major study of the Australian registry has more recently
from the registered anatomical landmarks. The major advan- shown evidence of a significant reduction in the revision rate
tage of image-free systems is that they do not require the of TKA in patients younger than 65 years (7.8% revision rate
in non-navigated versus 6.3% revision rate in navigated TKA
at 9 years follow-up) and a trend to fewer revisions in older
patients.14
However, some studies have demonstrated no differences
between computer-assisted navigation and conventional arthro-
plasty in terms of functional or clinical outcomes at up to 10
years after TKA.17 Spencer et al,27 in a randomised controlled
trial of 71 patients with a minimum of 2 years of follow-up,
found no significant difference in functional outcome scores
between patients managed with computer-assisted navigation
and those managed with conventional arthroplasty. Zhang
et al,19 Blakeney et al20 and Cip et al22 were all able to demon-
strate better alignments in CAS TKA but not any improved clin-
ical outcomes.
In a meta-analysis of seven studies and three registries, van
Figure 2  3D model of the patient’s femur based on intraoperative der List et al28 reported the difference in the annual revision rate
Copyright 2018 OMNI. (ARR) of computer navigation versus conventional TKA surgery
Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146 47
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State of the Art

Table 1  Recent studies comparing mechanical axis outliers in navigated total knee arthroplasty versus conventional instrumentation
Study Year Number of patients Outliers conventional Outliers navigation
19
Zhang et al 2011 32 (bilateral) 28% 0%
Blakeney et al20 2011 107 36%–38% (intramedullary and extramedullary) 19%
Tolk et al21 2012 100 50% 26%
Cip et al22 2014 200 19% 10%
Todesca et al23 2017 225 11% 4%

alignment, range of motion) is provided by the system. Despite


Essential features of computer-assisted surgery  (CAS) this, it is regarded as being less invasive (with no risk of fracture
total knee arthroplasty associated with bicortical tracker pin placement) and a faster
system to use than the fully navigated system.
1. CAS systems can be passive (navigated), semiactive or active There are four published studies in the literature reporting the
(robotics). outcome of ASM navigation for TKA. A randomised controlled
2. They can have an image-based modality (usually CT) or an trial by Harvie et al36 in a study with 40 patients, demonstrated
image-free modality. ASM navigation to be as accurate as full navigation regarding
3. Most of the systems are optically based and they rely on pin coronal and sagittal femoral and tibial cuts and that the oper-
trackers in femur and tibia for registration. ative time was significantly reduced. A retrospective compara-
4. Other options like surface-mounted and handheld CAS tive study37 of 200 knees illustrated that the femoral component
navigation have been developed. alignment was more accurate with ASM navigation compared
5. Regarding robotic systems, currently four platforms are with conventional intramedullary instrumentation (90% within
available. 3° of mechanical axis vs 74%). Singisetti et al38 reported on
the clinical outcomes using ASM navigation versus conven-
tional instrumentation and did not find clinical differences in
in 4 70 231 patients. Analysis showed an ARR of 0.55 in patients
WOMAC, SF-36 and Quality of life scores. Finally Clement
who underwent computer-navigated TKA surgery and an ARR
et al39 concluded that ASM navigation significantly reduces the
of 0.56 in patients who underwent conventional TKA surgery
number of outliers for the femoral and tibial components when
(P=0.58).
compared with conventional non-navigation alignment. (4% vs
11%, respectively)
Cost-effectiveness
The cost-effectiveness of these systems depends on many factors.
Hand-held navigation
The most commonly used assessment is to look at the cost savings
Trying to solve some of the problems associated with optical
associated with a reduced revision rate for arthroplasties that are
CAS has led to newer, hand-held accelerometer-based navigation
more accurately performed with navigation surgery.
However, the cost-effectiveness of computer-assisted naviga-
tion depends on the hospital volume of TKA procedures. Using
a Markov decision model, Slover et al29 found that hospitals
performing a high volume of TKA procedures (more than 150
TKAs a year) would experience a cost benefit in association with
the use of computer-assisted navigation as only modest reduc-
tions in the revision rate would make the technology cost-ef-
fective. On the other side, when clinical outcomes are taken
into account, there are several studies supporting that the insti-
tutional costs of computer-assisted navigation for TKA are not
justified with regard to improved clinical outcomes.30–32

Surface-mounted navigation
Navigated TKA does have specific complications associated with
the use of tracker pins. There have been several reports of peri-
prosthetic fractures from the tracker pin sites.33 34 There has also
been concerns regarding tracker movement during surgery espe-
cially in osteoporotic bone.35
The OrthoMap Express Knee Software (previously known
as ASM system) (Stryker, Mahwah, New Jersey, USA) (figure 3)
avoids the use of femoral and tibial pins by using mini jigs with
trackers that are attached to the femoral and tibial joint surfaces.
The process of mapping the knee is similar to other naviga-
tion systems but the ASM system only allows the planning of
the femoral and tibial cuts in the coronal and sagittal planes.
No checking of the bone cuts and no guidance to rotation are Figure 3  The OrthoMap Express Knee Software (Stryker, Mahwah, New
provided. After cuts are performed, the TKA proceeds a conven- Jersey, USA) surface mounted navigation system. Copyright Stryker 1998-
tional non-navigated procedure. No more information (limb 2018.
48 Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146
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State of the Art

Figure 4  KneeAlign Technology (OrthAlign, Aliso Viejo, California, USA)


handheld navigation system. Copyright 2014 OrthAlign, Inc.

systems to be developed. These incorporate dynamic motion


sensors and radiofrequency communication systems within the Figure 5  Pressure sensor data obtained during surgery using Verasense
surgical field. The idea of a handheld easy-to-use navigation (OrthoSensor, Dania Beach, Florida, USA). 
system was conceived in 2008, and the first system became clin-
ically available in 2009.16 The goal was a navigation system that
included no additional incisions, no pins in the femur or tibia, These trials have the shape of standard implant trial devices,
no external computer or device that would require line of sight so it can be designed for use in different total knee systems.
or a non-sterile operator, no capital equipment cost, little to no Currently, four major total knee systems make use of this
additional operating room time, a fast learning curve and accu- product.
racy equivalent to or better than currently available large console In the first study reporting clinical data related to Verasense,
navigation systems. Two systems are currently approved by the Gustke et al42 showed the 1-year data results from 135 knees in
US Food and Drug Administration (FDA) and on the market. 135 patients in a multicentre study. The quantitatively ‘balanced’
These systems are the KneeAlign Technology (OrthAlign, Aliso knees showed statistical improvement over the 6-month and
Viejo, California, USA) (figure 4) and the iASSIST Knee System 1-year follow-ups compared with the ‘unbalanced’ group. The
(Zimmer, Warsaw, Indiana, USA). Both systems work in similar American Knee Society Score of the ‘balanced’ group was 23.3
fashion using accelerometer technology. points higher than the ‘unbalanced’ group at 1-year follow-up.
The few studies available on these systems have shown Amundsen et al43 reported that the use of a constrained insert
improved alignment when compared with optically based CAS was significantly lower when doing an algorithmic pie-crusting
systems. Nam et al40 reported a 92.5% of patients getting an of the medial collateral ligament guided by Verasense comparing
alignment within 3° of the neutral mechanical axis compared to a classic release technique assessed using laminar spreaders,
with 86.3% when using an optical CAS system. Goh et al41 at 6 spacer blocks, manual stress and a ruler (5.3 vs 13.8%; P=0.049).
months after the surgery obtained mild improvements regarding Despite promising results, the literature is still limited and
alignment (with neutral mechanical axis as the target) with the with short follow-ups. Further studies using intraoperative
accelerometer-based CAS system, but they did not find any sensing technology are necessary to determine if the quantitative
differences in clinical outcomes scores or patient satisfaction. balancing of the knee translates to long-term improvements in
The reduced equipment and cheaper costs of these systems function or implant survivorship.
make them attractive and may contribute to easier availability
compared with optical CAS systems. However, current litera- Limitations
ture has not substantiated a clinical superiority of these systems Although TKA performed with navigation is associated with
over conventional TKA instrumentation even though there is a improved radiographic alignment, the use of computer-assisted
trend to better alignment results than optically based navigation navigation is associated with a number of potential drawbacks.
systems (and conventional instrumentation too) but still with Complications unique to navigated TKA have been reported
shortage of data to support this affirmation. and may occur in up to 17% of cases compared with conven-
tional TKA.44 Complications can be divided into registration
Pressure sensors errors, pin site complications, increased surgical time and longer
Studies reporting on the use of intraoperative sensing technology learning curve.45
are being increasingly published.42 These sensors can eliminate Registration errors: many navigation systems rely on the
the effect of inexperience on the judgement of amount of gap intraoperative registration of various anatomical landmarks,
balance. The model with most evidence available is Verasense which, if marked incorrectly, may lead to component malposi-
(OrthoSensor, Dania Beach, Florida, USA) (figure 5). This device tion. The most common registration errors occur at the femoral
has miniaturised integrated circuits and microprocessors that are epicondyles; such errors may lead to malrotation of the femoral
similar to those used in cell phones, and it communicates to a component.46
computer via a wireless link. The computer has a graphical inter- Pin site complications: component malposition also may occur
face which shows the pressures that are present and the loca- when markers that are drilled into the femur or tibia move during
tion of maximal contact between the medial and lateral femoral the course of surgery, particularly in patients with osteoporosis.
condyles. In this way, they provide feedback on contact pressures This emphasises the importance of the surgeon being aware of
and inferred kinematics from the contact points. this and checking the stability of these markers as well as not
Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146 49
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State of the Art


term robot refers to any mechanical device that is accurately
Tips and tricks in computer-assisted surgery total knee controlled by a computer with the use of intelligent software.17
arthroplasty (TKA) These robots can be classified into two main categories: active
and semiactive.49 50 Active systems act without the direct involve-
1. Avoid registration errors, especially femoral epicondyles ment of the surgeon. On the other hand, in semiactive systems,
which may lead to malrotation of the femoral component. the surgeon performs the procedure but with feedback from
2. Be aware of pin site complications. In patients with the robot to prevent errors during the process of making bony
osteoporosis, the stability of these markers should be checked cuts. The adequate term for this type of technology is ‘haptic
during surgery as well as not relying only on technological system’. Haptic feedback can be provided to the surgeon as
aids alone to achieve proper component position and auditory (beeping), tactile (vibratory) or visual (colour changes
alignment. in the computer screen). Other forms of semiactive technology
3. When using closed robotic TKA systems, decide if the benefits control the speed and deepness of the working instrument. In
of robotics outweigh the benefits you believe exist in the that way, if the surgeons are driving the bone cuts outside of
implant system. In the case of open systems, you may need to
the previous established margins, the system retracts the cutting/
decide if the benefits of the open implant options outweigh
burring instrument or decreases the speed of it so changes into
the loss of certain functionality in the robotic system.
the planning are prevented.
All orthopaedic robotic systems currently require a platform
and ‘preapproved’ plan on which to base the surgical procedure.
relying on technological aids alone to achieve proper component The surgical planning can be created from preoperative imaging
position and alignment. or from intraoperative landmark registration without the need
Fractures have been reported to occur around pin sites used for specific imaging. In both systems, the patients’ anatomy must
in navigated TKA and are unique to this procedure, occurring be registered via mapping points on the bone with a navigated
approximately 1% of the time.33 34 Other non-fracture pin site tool creating a three-dimensional frame of reference based on
complications have been described including multiple pin inser- the patient’s anatomy.
tion attempts, aborting navigated TKA as a result of pin loos- Robotic systems can have ‘closed’ or ‘open’ platforms
ening, haematoma, infection and nerve injury.15 These problems depending on if they allow only one manufacturer to be
should however be avoidable in experienced hands and with the implanted (closed) or different companies (open). Most plat-
appropriate training. forms are essentially open in nature, but commercial issues tend
Increased surgical time: an increase in operating room time to make them locked to a particular implant. In the case of a
for navigated TKA could be required as a result of the additional closed platform, a surgeon will need to decide if the benefits of
computer processing, pin and tracker placement, array registering using a robotic system outweigh the benefits they believe exist in
of data points and analysis of intraoperative data. This increase the implant (in the case the surgeon is not familiar to the implant
in operating room time is variable and ranges between increases ‘closed’ to the platform). In the case of open systems, potential
of 8 and 63 min depending on the publication.15 However, it drawbacks are that some specificity and functionality are gener-
has been suggested that time efficiency in navigated TKA may ally lost for the system to be able to become more universal. As
be gained by customising the navigation protocol to eliminate an example, many open systems cannot optimally predict kine-
certain steps.15 In the authors’ experience, once surgeons have matics for implant positioning.
become familiar with and competent with their preferred navi- Since Siebert et al51 published on the first series of robotic
gation system, the additional time is negligible. TKA (using a system that is not currently in use), several systems
Longer learning curve: as with any new surgical procedure, have been developed for TKA and unicompartmental knee
navigation involves a learning curve until the steady state is arthroplasty (UKA). Currently, there are four robotic platforms
obtained. Common sense dictates that the more sophisticated available. Each of them will be discussed separately.
the procedure is, the longer the learning curve will be. Navi-
gation systems are generally considered by non-user surgeons
as adding complexity to the procedure, especially as computer ROBODOC (Curexo Technology, Fremont, California, USA)
use is still uncommon in the operative field. However, Jenny The ROBODOC system debuted in 1992 focused on total hip
et al47 in a review article assessed several studies regarding this arthroplasty (THA). The system obtained FDA approval in 2008
topic and concluded that all studies support the hypothesis that but only for THA.52 Recently, the system has been expanded to
computer-navigated TKA involves only a short learning curve TKA. ROBODOC is an image-based (CT), autonomous, milling
and that beginners can obtain good results from the beginning robotic system.
of their experience, as navigation provides continuous feedback The preoperative CT data are imported into the ORTHODOC
during all phases of the knee replacement surgery and allows for Preoperative Planning Workstation and converted into a 3D
correcting any bone cut errors. Interestingly, there is no compa- virtual bone image which the surgeon can manipulate to view
rable research on the learning curve of TKA with standard, bone and joint anatomy and bone density. ORTHODOC has
manual instrumentation. One might postulate that this learning an extensive library of many commonly used knee implants and
curve might be longer than with navigation, with potentially a ultimately can incorporate any manufacturer’s implant. Using
higher rate of outliers.47 point and click controls, the surgeon selects and positions a 3-D
image of an implant within the reconstructed CT bone image
Active and semiactive CAS: robotics to achieve optimal fit and alignment for the patient’s anatomy.
Although computer-assisted navigation may improve component Using controlled, gentle pressure (2–2.5 lbs), ROBODOC mills
alignment, errors can still occur during the process of making the bone as specified by the ORTHODOC plan.
the bone cuts, leading to component malposition. This limitation Its clinical success and utility has been demonstrated in a
has led to the development of robotic-assisted knee arthroplasty series of clinical trials. In a study of 72 knees, Park and Lee53
in an effort to facilitate the preparation of bone surfaces.48 The compared outcomes of robotic assisted with conventional knee
50 Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146
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State of the Art


arthroplasty at mean follow-up of approximately 4 years. The
authors demonstrated better accuracy in the coronal femoral
component angles, sagittal femoral angle and sagittal tibial
angles between the robotic-assisted and conventional cohorts.
In this particular study, however, no differences in Knee Society
Scores were demonstrated.
Song et al54 55 performed two randomised clinical trials
comparing ROBODOC robotic-assisted and conventional
TKA. They found more reliable mechanical axis alignment and
femoral and tibial component positioning using ROBODOC and
also found that 12 out of 18 patients had a preference for the
ROBODOC-assisted TKA leg, while only six in the conventional
leg. In a follow-up study, they assessed soft tissue balancing
and found that more patients   with robotic-assisted TKA had
well-matched (within 2 mm) flexion-extension gap and more
satisfactory posterior cruciate ligament tension compared with
conventional TKA. In both studies, the ROBODOC-assisted
TKA procedures averaged 25 min longer than the manual proce-
dures but demonstrated less postoperative blood loss.
In another prospective randomised study consisting of 60
patients, Liow et al56 found no mechanical axis outliers (more
than 3° from neutral) or notching in the robot-assisted group as
compared with 19.4% (P=0.049) and 10.3% (P=0.238), respec-
tively in the conventional group. The robot-assisted group had
3.23% joint-line height outliers (>5 mm, using the Kawamura
and Bourne57 method) as compared with 20.6% in the conven-
tional group (P=0.049). Clinical outcomes were similar between
groups.
Disadvantages of this system are that the time needed for
registration and milling is greater than other robotics platforms.
Also, milling compared with cutting creates excessive heat that
could damage the surrounding bone. In addition, intraoperative
flexibility, and therefore surgeon’s involvement, is very limited.
Lastly, the software does not allow for live kinematic joint assess-
ment or final implant position information.

NAVIO (Blue Belt Technologies, Plymouth, Minnesota, USA)


NAVIO (figure 6) is an imageless, semiautonomous, burring
system that was designed originally to provide freehand
sculpting for unicompartmental (UKR) and patellofemoral knee
arthroplasty. The system obtained FDA approval in 2012. The
handheld cutting tool has an end-cutting burr that extends and
retracts so that only the planned bone is removed. The light-
weight robotic tool combines image-free intraoperative regis-
tration, planning and navigation with bone preparation. The
NAVIO software platform was formerly open to different UKR
Figure 6  NAVIO (Blue Belt Technologies, Plymouth, Minnesota, USA)
designs but right now is closed to one company implants. The
robotic-assisted total knee arthroplasty system. Copyright 2016 Smith
system is semiautonomous and works monitoring the surgeon
& Nephew.
movements of the burring tool using as feedback the retraction
of the burring tip when the surgeon goes out of the boundaries
of the planned resection. However, if the burr is moved too planned position guided by robotic assistance. There are no
quickly, bone outside the planned volume is able to be removed publications on this system to date.
before burr retraction. The system does not provide any haptic
feedback. iBlock
Lonner et al58 and Smith et al59 are the only published studies The iBlock robotic cutting guide (OMNIlife Science, East
to date and report reliable component positioning using the Taunton, Massachusetts, USA) (figure 7) is a motorised, bone-
NAVIO System in cadaveric and synthetic samples respectively. mounted cutting guide that positions the saw guide for all
No clinical studies regarding NAVIO have been published in femoral resections according to the surgeon’s plan, allowing the
PUBMED-indexed journals to this date. surgeon to then complete the resections with a standard oscil-
Recently, a new NAVIO system for TKR has been developed lating saw. It can be used in conjunction with the NanoBlock,
and obtained FDA approval in 2016 with the first procedure a separate, adjustable, resection block used for tibial resection.
carried out less than 1 year ago. The system is imageless, semi- The system obtained FDA approved in 2010. The OmniBiotics
autonomous and helps the surgeon to put the cutting jigs in the computer station is an imageless closed software package that
Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146 51
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State of the Art

Figure 7  iBlock robotic cutting guide (OMNIlife Science, East Taunton,


Massachusetts, USA). Copyright 2018 OMNI.

uses intraoperative registration to generate a unique 3D digital


model of the patient’s knee. The system allows for planning of
implant positioning and sizing intraoperatively and visualising
planned bone cuts before they are made. It also has good intra- Figure 8  Intraoperative image showing usage of the Mako (Rio; Mako
operative flexibility and the possibility of making recuts in an Stryker, Fort Lauderdale, Florida, USA) robot.
easy manner. In a cadaveric study,60 iBlock’s automated cutting
guide resulted in more efficient and more accurate femoral cuts
in comparison to the conventional navigation method. et al63 showed the first 10 patients with UKA treated with the
There is limited clinical data available for this system; however, Mako system (Mako Surgical, Fort Lauderdale, Florida, USA)
the evidence available is promising. Suero et al61 performed a were within 1.6° of the mechanical axis. The mean tourniquet
study in 94 patients who underwent TKA using either Nano- time was 87.4 min (68–113 min) and overall operation time
Block (n=30) or conventional cutting blocks (CCB) (n=64) for 132 min (118–152 min) in the study. In a series of 20 patients,
the tibial cut. They found that postoperative mechanical align- Dunbar et al64 showed reliable positioning of both components
ment variability was significantly less in the NanoBlock group comparing to the preoperative planning using this system.
(SD=1.7°) than in the CCB group (SD=2.7°). Tourniquet time Furthermore, Plate et al65 showed in 52 knees undergoing UKA
was significantly reduced by 14.8 min in the NanoBlock group using the Mako system that soft tissue balancing was accurate up
compared with the CCB. Differences in component alignment to 0.53 mm compared with the preoperative plan and 83% of
were not significant. the cases were within 1 mm of soft tissue balance comparing to
Clark and Schmidt62 compared iBlock with computer-assisted the preoperative plan throughout the range of motion (ROM).
navigation in primary TKA. In their study, iBlock navigation Several comparisons have been made between Mako and
times were, on average, 9.0 min shorter compared with navi- manual instruments for UKR. Lonner et al66 showed in a clin-
gation after adjustment. The average absolute intraoperative ical study using the Mako system, that robotic-assisted surgery
malalignment was 0.5° less in the iBlock procedures compared had increased mechanical axis accuracy and more accurate tibial
with the navigated procedures after adjustment. Patients in the component alignment compared with manual UKA. MacCallum
iBlock group tended to be discharged 0.6 days earlier compared et al67 showed in a clinical study that robotic-assisted surgery
with patients in the navigation group after adjustment. with the Mako system was more precise in the coronal and
tibial planes for baseplate positioning when compared with
Mako manual UKA.
The Robotic Arm Interactive Orthopaedic System (Rio; Mako In the only level I study regarding Mako, Bell et al68 randomised
Stryker, Fort Lauderdale, Florida, USA) (figure 8) is available 139 patients to either Mako-assisted or conventional surgery. A
in clinical practice for UKR, THA and TKA. As an image-based postoperative CT was performed at 3 months to assess the accu-
system, a preoperative CT is used to determine a surgical plan; racy of the axial, coronal and sagittal component positioning.
this can be adjusted intraoperatively depending on the in-vivo All component positioning parameters were more accurate with
registration before making any bone cut. Mako provides haptic the robot compared with conventional surgery (P<0.01). The
feedback to prevent any errors during cuts. proportion of patients with component implantation within
The Mako system is currently available for robotic assisted 2° of the target position was significantly greater in the group
UKA and THA procedures, and the total knee platform has who underwent robotic-assisted arthroplasty compared with the
recently been FDA approved. The cutting tool is attached to group who underwent conventional arthroplasty with regard
the haptic arm. For the UKR, it is a high-speed burr and for to the femoral component sagittal position (57% vs 26%,
the TKR an oscillating saw. The arm provides haptic feedback P=0.0008), femoral component coronal position (70% vs 28%,
and constrains the movement of the cutting instrument which is P=0.0001), femoral component axial position (53% vs 31%,
guided by the surgeon. P=0.0163), tibial component sagittal position (80% vs 22%,
At this stage, published data have focused on the accuracy of P=0.0001) and tibial component axial position (48% vs 19%,
the Mako system in implant positioning and alignment. Pearle P=0.0009).
52 Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146
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State of the Art


Limitations reasonable evidence of the bony accuracy of these systems.48
Robot-assisted surgery shares most of its disadvantages with In the future, robotics is moving towards becoming a valuable
navigated surgery including the additional duration of the adjunct to the surgeon in delivering patient-specific arthroplasty
surgery, cost, radiation associated with a preoperative CT (when with patient-specific alignment targets. Although additional
it is needed by the platform) and pin tracker related problems research will be required to fully define the costs and benefits of
(fractures, loosening and so on). robotics in regular medical practice.
On the other hand, disadvantages of robotic-assisted proce-
dures compared with navigated-assisted surgery are the lack of Contributors  FF: writing process. DP and SO: reviewing and editing process. BF:
versatility intraoperatively with the first one, which can result writing, reviewing and editing process.
in the abandonment of the robotic procedure and conversion Competing interests  None declared.
to a conventional procedure. Other disadvantage is the high Patient consent  Obtained.
start-up cost and learning curve associated with the use of any Provenance and peer review  Commissioned; externally peer reviewed.
new technology, which may be prohibitive for many surgeons
© International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports
and hospital systems. Medicine (unless otherwise stated in the text of the article) 2018. All rights reserved.
No commercial use is permitted unless otherwise expressly granted.
Cost-effectiveness
The added costs of using robotics-assisted surgery can be justi-
fied by improved outcomes such as fewer complications, implant References
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54 Figueroa F, et al. JISAKOS 2018;3:46–54. doi:10.1136/jisakos-2017-000146


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New and evolving technologies for knee


arthroplasty−−computer navigation and
robotics: state of the art
Francisco Figueroa, David Parker, Brett Fritsch and Sam Oussedik

J ISAKOS2018 3: 46-54 originally published online January 23, 2018


doi: 10.1136/jisakos-2017-000146

Updated information and services can be found at:


http://jisakos.bmj.com/content/3/1/46

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