Journal Pre-proof

Technology in Total Knee Arthroplasty in 2023

Cale Pagan, MD, Theofilos Karasavvidis, MD, Anna Cohen-Rosenblum, MD, Charles
P. Hannon, MD, MBA, Adolph V. Lombardi, MD, Jonathan Vigdorchik, MD

PII: S0883-5403(24)00751-4
DOI: https://doi.org/10.1016/j.arth.2024.07.028
Reference: YARTH 60931

To appear in: The Journal of Arthroplasty

Received Date: 20 December 2023

Revised Date: 15 July 2024
Accepted Date: 17 July 2024

Please cite this article as: Pagan C, Karasavvidis T, Cohen-Rosenblum A, Hannon CP, Lombardi AV,
Vigdorchik J, Technology in Total Knee Arthroplasty in 2023, The Journal of Arthroplasty (2024), doi:
https://doi.org/10.1016/j.arth.2024.07.028.

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© 2024 Published by Elsevier Inc.

Technology in Total Knee Arthroplasty in 2023

Cale Pagan MD1, Theofilos Karasavvidis MD1, Anna Cohen-Rosenblum MD2, Charles P. Hannon MD,
MBA3, Adolph V. Lombardi MD4, Jonathan Vigdorchik MD1

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Adult Reconstruction and Joint Replacement Service, Department of Orthopaedic Surgery, Hospital for
Special Surgery, New York, NY, USA

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Department of Orthopaedic Surgery, Louisiana State University, New Orleans, LA

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Deparment of Orthopaedic Surgery, Mayo Clinic, Rochester, Minnesota, USA

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Joint Implant Surgeons, New Albany, OH

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Please address correspondence to:
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Cale Pagan MD
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Department of Orthopaedic Surgery

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Hospital for Special Surgery

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535 East 70th Street

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New York, NY, USA, 10021

Email: [email protected]

Tel: +1 701-202-7238

Word count of the abstract: 82

Word count of the text: 3778

 1 Technology in Total Knee Arthroplasty in 2023

3 Abstract

4 Over the past few decades, instrumentation and techniques for total knee arthroplasty (TKA) have
5 evolved from conventional manual tools to a wide range of technologies, including calibrated
6 guides for accurate bone cuts and alignment, smart tools, dynamic intraoperative sensors for soft-
7 tissue balancing, patient-specific guides, computer navigation, and robotics. This review is
8 intended to provide an overview of the latest advancements in TKA technology, address potential

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9 challenges and solutions related to the application of these technologies, and explore their
limitations.

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25 Introduction

26 Total knee arthroplasty (TKA) demonstrates remarkable long-term implant durability and
27 high survival rates in patients who have severe knee osteoarthritis.[1,2] However, patient
28 dissatisfaction following an uncomplicated primary TKA is well documented and occurs at an
29 average rate of 10 to 20% [3,4]. An effort to enhance precision, accuracy, and ultimately improve
30 patient outcomes has brought forth the integration of technology in TKA. Tools such as patient-
31 specific instrumentation (PSI), computer-assisted navigation (CAN), and robotic-assisted surgery
32 aim to improve postoperative satisfaction by accommodating each patient’s unique anatomy [5].

33 Although studies have demonstrated improved radiographic alignment and component

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34 positioning with technology-assisted TKA, a consensus has yet to be reached as to whether it leads

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35 to improved long-term outcomes.[6–8] This suggests that factors such as patient selection and

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36 expectation management also play crucial roles in overall satisfaction. For example, Polkowski et
al. found that patients who had less than Grade 3 or 4 osteoarthritis (OA) preoperatively were more
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38 likely to be dissatisfied after TKA, even if the procedure was technically successful [9].
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39 Surgeons must also ensure that patients have realistic expectations, which requires
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40 extensive conversations with each patient, aiming to reach a mutual understanding of the surgical
41 goals. For instance, patients who are indicated for a TKA with a pre-operative range of motion of
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42 greater than 120 degrees must be advised that they may be limited to less than 120 degrees post-
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43 operatively [10]. Fostering these expectations is crucial, as meeting expectations has been
44 inextricably linked to satisfaction following the procedure [11,12].

45 Incorporating new technologies into practice requires a balance between understanding

46 new advancements and adhering to proven surgical principles. A growing body of clinical evidence
47 has been published comparing these technologies to manual techniques across various outcome
48 measures. This review aims to explore the most recent advancements in TKA technology, delve
49 into the evidence surrounding technology and postoperative outcomesand discuss their limitations.

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51 Computer-Assisted Navigation: A Simple, Cost-Effective Solution

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52 To overcome the limitations of conventional measured resection and gap balancing, CAN
53 was developed to improve the accuracy of bone resection planes, restore intercompartmental joint
54 function, and achieve balanced flexion and extension gaps [13]. The use of CAN has been shown
55 to reduce outliers in the coronal plane of the tibial component and mechanical axis, indicating
56 superior accuracy and precision compared with conventional TKA [14]. In simple terms, CAN
57 involves the use of computer assistance to position cutting guides, replacing traditional
58 intramedullary femoral or extramedullary tibial alignment guides.

59 Various systems with diverse specifications are available, including open-platform options
60 compatible with a range of company implants and closed, implant-specific alternatives.

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61 Additionally, the systems employ either handheld consoles or arrays with additional pins,

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62 accompanied by an external computer that is non-sterile. While all systems assist in determining
63 the distal femur and proximal tibial bone cuts, certain systems offer additional features such as
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evaluating component rotation, gap balancing, and sizing (Figure 1) [15–17].
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65 Studies have demonstrated either no significant difference in operative time or a very short
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66 learning curve, in as few as 10 cases [18,19]. Despite notable advancements in CAN, long-term
67 survival rates have not exhibited significant improvement compared to conventional TKA, with
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68 similar revision rates between CAN and manual TKA [20–22]. According to the American
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69 Academy of Orthopaedic Surgeons (AAOS) 2022 clinical practice guidelines, there is a moderate
70 recommendation to support no difference in outcomes, function, or pain between navigation and
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71 conventional techniques, but that some surgeons may prefer to use CAN despite the lack of proven
72 outcomes differences at this time [23].

73 The use of CAN offers numerous advantages over both conventional instrumentation and
74 other technologies in TKA. For example, utilizing a computer to establish the femoral cut angle
75 eliminates the necessity of instrumenting the femoral canal as is performed in conventional TKA.
76 This proves especially beneficial in patients who have extra-articular femoral deformity or retained
77 hardware, where the use of an intramedullary guide is precluded. Unlike other TKA technology
78 platforms, CAN does not require preoperative imaging. This eliminates certain challenges
79 associated with cost, insurance authorization, and radiation exposure. In addition, CAN is often
80 handheld and does not require large additional pieces of equipment in the operating room, which
81 is beneficial for centers with space limitations, such as ambulatory surgery centers. Also, CAN is

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 82 relatively easy for surgeons and operating room staff to put together and utilize without extensive
83 additional training [24].

84 Further advantages include adaptability to various alignment strategies and reducing

85 outliers [25]. The CAN also provides trainees who have instrument haptics and concepts similar
86 to conventional TKA while introducing them to technological innovations [26]. Several CAN
87 systems are also open platforms, allowing surgeons to utilize multiple implant systems with the
88 same technology. Calculating cost effectiveness is challenging due to the variability in system
89 costs, but CAN generally incurs a much lower capital cost than most robotic systems. A Current
90 Procedural Terminology (CPT) code (20985) for computer-assisted navigation in musculoskeletal

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91 procedures is also available, though approval by insurance companies may not always be

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92 guaranteed [27,28].

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93 As for the disadvantages, instrument calibration and registering points in CAN are more
complex than setting the distal femoral cut angle via a rod in the femoral canal, and there is always
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95 the possibility of system failure. Some CAN systems may lack features such as sizing, gap
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96 balancing, and rotational alignment akin to a robot, and if intraosseous pins are used, there is a
97 potential for pin site complications along with the need to process additional instruments [29].
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98 From an educational perspective, it is important to consider that with the increased adoption of
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99 TKA technology, orthopaedic trainees will have fewer opportunities to become proficient with
100 conventional instrumentation. From a cost perspective, while CAN may be more cost effective
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101 than robotics, it does incur increased costs compared to conventional TKA.

102 The most user-friendly types of CAN systems are the handheld, open-platform,
103 accelerometer-based ones, which do not require trans-osseous pins, arrays, or additional computer
104 screens, with registration limited to the center of the distal femur, center of the tibia, and malleoli.
105 This approach is particularly suitable for patients who have retained hardware or a femoral
106 deformity that hinders the use of intramedullary guides and can subsequently be expanded to
107 include all patients. In patients who have a high body mass index, it is important to locate and
108 palpate both malleoli for registration. A practical approach is to prepare these patients by placing
109 electrocardiogram (EKG) leads over the medial and lateral malleoli to assist in their intraoperative
110 registration. Overall, CAN offers increased precision for achieving desired alignment without the
111 need for preoperative imaging, major capital costs, or extensive staff training; however,

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112 considerations include trainee education, costs relative to standard instrumentation, and a lack of
113 conclusive evidence on long-term clinical outcome benefits, emphasizing the importance of
114 discerning differences among CAN systems when selecting the most suitable option.

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116 Augmented Reality

117 Augmented reality is a technology that enhances the perception of the real world by
118 overlaying digital information onto physical images. It utilizes a headset to identify anatomic
119 landmarks, register, and plan cuts. Augmented reality systems may provide surgeons who have

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120 holographic guidance during procedures, indicating the planned resection angles and depths for
the tibia and femur. To assess the accuracy and precision of these systems, comprehensive

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122 preclinical and clinical studies are required, though initial findings appear promising. Similar to
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other marker-based navigation systems, this augmented reality approach benefits from being
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124 imageless and does not rely on consumable materials [30,31].
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125 There are a variety of platforms currently available or on the horizon, each with different
126 specifications related to the headset, preoperative imaging, and open platform capabilities.
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127 However, the current state of these technologies is in the early stages of development, and there is
a lack of sufficient clinical data to draw conclusive assessments. Further research is warranted to
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129 investigate both the clinical outcomes and surgeon ergonomics associated with this type of
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130 platform [30,32].

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132 Patient-Specific Instrumentation

133 Designed to streamline and personalize the prosthetic implantation process, PSI involves
134 generating patient-specific cutting blocks. These blocks are tailored to each patient's unique
135 anatomical structure, derived from three-dimensional models created using pre-operative
136 computed tomography (CT) scans or magnetic resonance images (MRI). The PSI guides are then
137 utilized to execute predetermined resection depths, rotations, slopes, and cut angles. However,
138 research evaluating the precision of PSI has yielded varying results [33], and studies comparing
139 functional and clinical outcomes between PSI and traditional instrumentation have not identified

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140 statistically or clinically significant differences [34,35]. Despite this, the potential benefits of PSI
141 include a decrease in the number of required instrument trays, and potential cost advantages in
142 comparison to other technologies [35].

143 While alignment philosophies continue to be a topic of discussion, interest in PSI has
144 increased as a means to implement specific alignment strategies more precisely[25,36]. Similarly,
145 custom-made implants are designed to reproduce the native anatomy of the knee using a single-
146 use tailored implant. Customization offers the benefit of an implant that accurately fits a patient’s
147 anatomy, optimizing bone-implant fit, restoring of the native condylar curvature, and improving
148 patello-femoral tracking through decoupling of the patello-femoral compartment from the

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149 tibiofemoral compartment [37].

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151 Intraoperative Pressure Sensors

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152 Soft-tissue balancing is believed to be a major factor in achieving a successful outcome in
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153 TKA. Currently, the concept of “balance” is gauged by the subjective feel of each surgeon and the
154 individual judgment of what they feel as appropriate ligament tension. Pressure sensors are
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155 polyethylene trials that have been developed to provide objective measurements of pressure in the
medial and lateral tibio-femoral compartments and contact points for the femoral and tibial
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157 components throughout the range of motion.[38] These devices can provide a quantifiable
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158 measurement of pressure in real-time, serving as a surrogate for balance. Studies have assessed the
159 results of sensors on ligament balancing. Cho et al. reported a 94% success rate in achieving a
160 quantifiably balanced knee with the use of the sensor [39]. Similarly, in a randomized controlled
161 trial of 284 TKAs, MacDessi et al. reported a four-fold decrease in unbalanced knees with the
162 implementation of the sensor [40]. Despite this, neither improvement in functional nor clinical
163 outcomes was reported. Nevertheless, these instruments are a step forward in the objective
164 quantification of soft-tissue balance. The integration of these sensors may be beneficial in
165 identifying tendencies or habits in one’s own practice. Yet, it is important to acknowledge that
166 while these sensors measure compartment pressure, they do not yet directly evaluate the soft-tissue
167 tension. This underscores the necessity for continued innovation and the development of
168 comprehensive tools that can directly measure and guide soft tissue balancing in TKA. To achieve
169 this, future research studies in this field should thoroughly examine preoperative joint distraction

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170 imaging, which allows for the incorporation of soft tissue tension preoperatively, and modern
171 intraoperative devices that leverage artificial intelligence to achieve optimal soft-tissue balance for
172 each patient.

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174 Robotic-Assisted TKA

175 For over 30 years, digital robotics and enabling technologies have been investigated in an
176 attempt to reduce failure mechanisms following TKA [41]. These systems have provided surgeons
177 who have a tool that has shown enhanced accuracy and consistency in component placement when

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178 compared to conventional instrumentation .[42–44] The use of robotic assistance in primary TKA
has increased by more than sixfold since 2017, and according to recent registry data, robotic TKAs

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180 account for approximately 13% of all TKAs performed in the US and over 30% in Australia
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[22,45]. Robotics have undergone rapid evolution in recent years and exhibit major variation in
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182 design and capability, with all major implant companies now offering some form of robotic-
assisted TKA.
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184 Key considerations for different robotic platforms include: 1) whether preoperative
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185 imaging is required and, if so, what type; 2) the registration process; 3) soft-tissue balancing
capabilities; 4) the cutting tool; and 5) guidance features. Robotic systems are categorized as either
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187 closed, limited to specific implant designs from a single manufacturer, or open, allowing the
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188 utilization of various implant designs from different manufacturers. Table 1 provides a
189 comprehensive overview of the features of the major robotic platforms currently available.

190 Imageless robotic platforms can potentially reduce radiation exposure; however, they may
191 lack precision in interpolative translation to three-dimensional virtual modeling, fail to display all
192 bone geometry details such as osteophyte size and location, and rely solely on the surgeon's
193 accuracy during bony landmark registration [41,46]. Imageless robotic-assisted TKA involves the
194 placement of arrays within the knee for registration, which is instrumental in informing the robot
195 about the location of the bone in space. Subsequently, soft-tissue balancing with gap assessments
196 is performed, and finally, the surgical plan is implemented using various saws or burrs.

197 Image-dependent robotic systems are based on preoperative imaging (typically CT) to
198 generate an accurate three-dimensional virtual model of the distal femur and proximal tibia. This

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199 model aids in preoperative planning for bone cuts, component size, and positioning, and creating
200 a preoperative template. During the procedure, this template can be mapped to the patient's bony
201 anatomy and degree of deformity. Registration can be performed through surface registration,
202 involving the movement of the knee center, or by selecting specific points on the bone. This process
203 informs the robot about the bone's location, and the robot retains this information based on the
204 arrays and cameras used during the procedure.

205 Traditionally, soft-tissue balancing involved the use of spacer blocks to assess tension. In
206 robotic-assisted TKA, soft-tissue balancing consists of applying varus and valgus stress in
207 extension and flexion, allowing the robot to provide gap measurements and assess laxities.

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208 Balancing can then be achieved through a combination of bone cuts and soft tissue releases.

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209 Current literature extensively documents the high accuracy and precision of robotic-assisted total
210 TKA in implant positioning. This technology allows surgeons to reliably implement individualized
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alignment strategies during surgery, minimizing soft tissue releases and allowing for the use of
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212 press-fit implants in indicated patients [25,47–50].
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213 Robotic systems are divided into active, semi-active, and passive systems with varying
214 levels of control and sophistication. Active systems include robotic arms that operate
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215 independently with minimal guidance from the surgeon. Semi-active systems offer feedback
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216 through various cues and safeguards designed to limit unintended soft-tissue or neurovascular
217 injuries, with surgeon input to guide the robotic arm, while passive systems provide complete
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218 control to the surgeon based on computer-assisted three-dimensional templating or imageless

219 intraoperative landmark registration.[51–53] Although each system has slight variations, they all
220 serve the same purpose, performing bone cuts according to the preoperative plan established in
221 earlier steps.

222 As is expected with any new technology or technique introduced in the operating room,
223 there may be a learning curve present. This learning curve may lead to disruptions in operating
224 room efficiency. While achieving good patient outcomes and a low complication rate can be
225 achieved from the first case, the efficiency learning curve typically requires 6 to 10 cases to become
226 familiar with the platform [46,54,55]. However, in a study examining the operative time curves
227 for robotic-assisted TKA among 146 surgeons at 30 hospitals, a majority of them were able to
228 achieve the same operating time as manual cases. [56] This indicates that, while initial adoption

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229 of robotic-assisted TKA may introduce temporary inefficiencies, most surgeons can adapt to the
230 technology, maintaining surgical benchmarks similar to traditional methods.

231 The 2023 Australian Orthopaedic Association National Joint Replacement Registry
232 (AOANJRR) report indicates no significant difference in overall revision rates between robotic
233 and non-robotic TKA [22]. However, when examining a specific implant from a single company
234 in the AOANJRR report, robotic-assisted TKA demonstrated significantly lower revision rates
235 compared to CAN or manual TKA [22]. Outcome variations may arise not necessarily from the
236 distinction between robotic and non-robotic TKA but rather from factors such as alignment and
237 soft tissue balance, with robotics enabling their precise execution.[57,58] The effectiveness of the

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238 surgical plan depends on the ability to execute it, and arthroplasty as a field is continually seeking

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239 to understand different knee phenotypes and balancing techniques in order to improve surgical
240 outcomes.[36,59]

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How to Detect When Technology is Leading You Astray and How to Handle It
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243 The use of technology in TKA introduces concerns for unique complications not present in
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244 conventional TKA, such as array or pin-related failures, registration errors, and software or
mechanical malfunctions. A thorough understanding of each individual technology and its
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246 components can help prevent many of these challenges, thereby ensuring patient safety. It is
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247 beneficial to analyze the common issues that may arise during different stages of the computer-
248 navigated or robotic-assisted procedure. An overview of the most frequently encountered
249 technological failure scenarios is included below.

250 Studies specifically addressing the failures and malfunctions of contemporary TKA
251 systems are scarce, but an analysis of the US Food and Drug Administration (FDA) Manufacturer
252 and User Facility Device Experience (MAUDE) database reveals insightful data. The MAUDE
253 database serves as a digital repository of reports on adverse events associated with medical
254 devices.[60] Pagani et al. reported that the overall rate of adverse events related to robotic-assisted
255 total hip arthroplasty (THA) was 0.28%, and the overall rate of adverse events related to robotic-
256 assisted TKA was 0.85%.[61] During robotic-assisted TKA, the most frequent adverse events were
257 unexpected robotic arm movement during the bone cuts (59 of 204, 28.9%), inaccurate bone cuts

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258 (26 of 204, 12.7%), and leakage of fluid or residue contaminating the robotic component (25 of
259 204, 12.3%). Despite the relative rarity of these adverse events, their potential impact on surgical
260 outcomes cannot be understated.

261 Errors in image-based systems can occur before the procedure even begins and may be
262 prevented by a preoperative review of the imaging to ensure adherence to appropriate imaging
263 protocols. Early detection of problems allows for the repetition of imaging if necessary. Arrays,
264 which are pivotal in communicating the anatomic landmark’s position in space to the computer or
265 robot, are secured onto pins inserted into the distal femoral and proximal tibia. While overall low-
266 risk, these pins represent an additional step and could lead to complications such as pin-site

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267 infections, intraoperative pin loosening, or postoperative pin-related fractures. However, a study

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268 by Yun et al. involving 2,603 knee arthroplasties (1,702 TKAs and 901 unicompartmental knee
269 arthroplasties [UKAs]), reported no instances of array loosening in their series [62]. Reported
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incidences of femoral or tibial shaft fractures due to pin placement range from 0.065 to 1.3%
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271 [63,64]. Ensuring that pins are securely fastened in the bone to prevent loosening is particularly
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272 crucial, especially in patients who have osteoporosis. If there is any motion of pins or arrays during
273 the procedure, it may require conversion to conventional instrumentation if the recovery
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274 algorithms fail. In the event that pins loosen during the procedure, troubleshooting will depend on
275 when the failure occurred. If pins loosen prior to the bone cuts, the pins may be repositioned, and
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276 re-registration may be performed. If the pins become loose after bony cuts have been made, they
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277 must be tightly secured, and re-registration may be performed if bone is still present in the
278 transverse plane. In the scenario in which the array is moved, a similar procedure is followed. If
279 the array is moved prior to bone cuts, the array should be secured, and bony anatomy should be
280 re-registered. In the event that the array is moved after bone cuts, an effort should be made to
281 restore the array to its original position, and re-registration must be performed on the remaining
282 bone. Image-based systems may confer an advantage in these recovery procedures as there is an
283 anatomical model that may be revisited.

284 Registration errors represent another potential for failure in technology-assisted TKA.
285 Inaccurate registration leads to incorrect data and can compromise the execution of the planned
286 procedure. Errors in point selection can result in inaccurate mapping, particularly in imageless
287 systems that rely solely on this information for guidance. It is essential to be meticulous about

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288 referencing points. If unsuccessful checkpoint verification occurs following registration, the
289 previous registration step should be redone. If registration is successful in three planes, but the
290 checkpoint verification still fails, it is likely that the checkpoint has moved, in which case the
291 checkpoint should be reinserted in as stable bone as possible and recaptured. If the registration is
292 still unsuccessful, this may be an indication of array movement, and the array recovery procedure
293 must be undertaken.

294 The stage at which errors may be most apparent is during the execution of bone cuts. Should
295 there be any concern about the precision of these cuts, it is imperative to confirm the integrity of
296 the surgical array and the accuracy of its registration. Incorporating simple yet effective

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297 instrumentation tools, such as the tibial drop rod or caliper, into the workflow can greatly assist in

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298 verifying the accuracy of bone cuts. Furthermore, applying clinical judgment is invaluable for
299 ensuring the appropriateness of cuts. For instance, conducting a straightforward visual inspection
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for the “grand piano sign” after making the anterior femoral cut can act as a critical safety measure
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301 to assess the proper rotation of the femoral component. Some robotic systems are also equipped
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302 with specialized tools designed to validate the accuracy of bone cuts, providing an extra layer of
303 validation and error management.
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304 In instances where technology leads the surgeon astray, trusting one's clinical judgment and
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305 being prepared to troubleshoot when necessary are vital. Keeping a record of the final implant
306 planning screen can serve as a guide in such scenarios. It is essential to maintain all cuts for
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307 measurement and validation of what has been performed. How to recover from intraoperative
308 technology failure also depends on when the technology fails. Strategies for recovering extension
309 and flexion gaps include confirming resection measurements and utilizing manual instruments or
310 gap balancers, with adjustments in femoral rotation and possible soft tissue releases.

311 Also, preventing technology failures is as crucial as managing them. Daily pre-surgery checks,
312 a robust maintenance program, and immediate reporting of any suspected issues to the
313 manufacturer are simple, yet essential preventative measures.

314 Although technology is a great tool in TKA to increase accuracy and precision, the potential
315 for error still exists. With the adoption of these technological tools comes the responsibility for
316 surgeons to not only understand their use but also to be adept at identifying and rectifying errors
317 when they arise.

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319 Conclusion

320 While the quest for perfection in TKA is ongoing, it is understood that absolute perfection
321 may be an unachievable goal. However, it is this very pursuit that drives continual improvement.
322 The commitment to advancing TKA must be measured and deliberate. We must evaluate all
323 technology to see how it makes us better surgeons, to deliver the best operation and most optimal
324 care in the most efficient manner.

325 Emerging tools like patient-specific instrumentation, augmented reality, computer-assisted

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326 navigation, and robotic-assisted surgery are at the forefront of this evolution, offering
unprecedented precision, reliability, and customization in TKA procedures. As we look ahead, the

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328 future of TKA promises a seamless integration of comprehensive preoperative planning, precise
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consideration of individual patient anatomy, meticulous soft tissue balance assessment, and
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330 advanced surgical tools capable of executing these plans with unparalleled accuracy. This
comprehensive approach symbolizes not just a technical evolution, but a commitment to patient-
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332 centered care, setting new benchmarks in orthopaedic surgery.
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344 References

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531

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532 Figure Legends

533 Figure 1. Examples of computer-assisted navigation systems and their specifications

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556 Figure 1. Examples of computer-assisted navigation systems and their specifications

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558 Table 1. Overview of different robotic platforms and characteristics. (CT)=Computed Tomography.
559 (XR)=X-Ray.

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