Total knee arthroplasty (TKA) is currently one of the most common orthopedic surgeries due to the ever-increasing average life expectancy. The constant need for effective and accurate techniques was contributed to the development of three-dimensional (3D) printing in that field, especially for patient-specific instrumentation (PSI) and custom-made implants fabrication. PSI may offer numerous benefits, such as resection accuracy, mechanical axis alignment, cost-effectiveness, and time economy. Nonetheless, the results of existing studies are controversial. For this purpose, a review article of the published articles was conducted to summarize the role of 3D-printed PSI in TKA.

Implant malalignment may be a risk factor for poor patient-reported outcomes measures (PROMs) following total knee arthroplasty (TKA).

Postoperative surveys were administered to assess PROMs regarding satisfaction, pain, and function in 262 patients who underwent surgery at 4 centers in the U.S. and U.K (average age, 67.2) at a mean 5.5 years after primary TKA. Postoperative distal femoral angle (DFA), proximal tibial angle (PTA), and posterior tibial slope angle (PSA) were radiographically measured, and outliers were recorded. PROMs were compared between patients with aligned versus malaligned knees using univariate analysis.

Patients with DFA, PTA, and PSA outliers were more likely to experience similar or decreased activity levels postoperatively than patients with no alignment outliers, as were patients with 1 or 2 outliers of any kind (P < .05). Patients with DFA, PTA, and PSA outliers were significantly more likely to be dissatisfied with their ability to perform activities of daily living (ADLs), as were patients with 1 or 2 outliers of any kind (P < .05). Patients with DFA and PSA outliers were more likely to be dissatisfied with their degree of pain relief, as were patients with 2 outliers of any kind (P < .05). Finally, patients with DFA and PSA outliers, as well as those with 1 outlier of any kind, were more likely to be dissatisfied with their overall knee function (P < .05).

DFA, PTA, and PSA outliers represent a significant risk factor for decreased satisfaction with activities of daily living(ADLs), pain relief, and knee function, as well as decreased activity levels.

Level III.

Implant malalignment may predispose patients to prosthetic failure following total knee arthroplasty (TKA). A more thorough understanding of the surgeon-specific factors that contribute to implant malalignment following TKA may uncover actionable strategies for improving implant survival. The purpose of this study was to determine the impact of surgeon volume and training status on malalignment.

In this retrospective multicenter study, we performed a radiographic analysis of 1,570 primary TKAs performed at 4 private academic and state-funded centers in the U.S. and U.K. Surgeons were categorized as high-volume (≥50 TKAs/year) or low-volume (<50 TKAs/year), and as a trainee (fellow/resident under the supervision of an attending surgeon) or a non-trainee (attending surgeon). On the basis of these designations, 3 groups were defined: high-volume non-trainee, low-volume non-trainee, and trainee. The postoperative medial distal femoral angle (DFA), medial proximal tibial angle (PTA), and posterior tibial slope angle (PSA) were radiographically measured. Outlier measurements were defined as follows: DFA, outside of 5° ± 3° of valgus; PTA, >±3° deviation from the neutral axis; and PSA, <0° or >7° of flexion for cruciate-retaining or <0° or >5° of flexion for posterior-stabilized TKAs. "Far outliers" were defined as measurements falling >± 2° outside of these ranges. The proportions of outliers were compared between the groups using univariate and multivariate analyses.

When comparing the high and low-volume non-trainee groups using univariate analysis, the proportions of knees with outlier measurements for the PTA (5.3% versus 17.4%) and PSA (17.4% versus 28.3%) and the proportion of total outliers (11.8% versus 20.7%) were significantly lower in the high-volume group (all p < 0.001). The proportions of DFA (1.9% versus 6.5%), PTA (1.8% versus 5.7%), PSA (5.5% versus 12.6%), and total far outliers (3.1% versus 8.3%) were also significantly lower in the high-volume non-trainee group (all p < 0.001). Compared with the trainee group, the high-volume non-trainee group had significantly lower proportions of DFA (12.6% versus 21.6%), PTA (5.3% versus 12.0%), PSA (17.4% versus 33.3%), and total outliers (11.8% versus 22.3%) (all p < 0.001) as well as DFA (1.9% versus 3.9%; p = 0.027), PSA (5.5% versus 12.6%; p < 0.001), and total far outliers (3.1% versus 6.4%; p = 0.004). No significant differences were identified when comparing the low-volume non-trainee group and the trainee group, with the exception of PTA outliers (17.4% versus 12.0%; p = 0.041) and PTA far outliers (5.7% versus 2.6%; p = 0.033). Findings from multivariate analysis accounting for the effects of patient age, body mass index, and individual surgeon demonstrated similar results.

Low surgical volume and trainee status were risk factors for outlier and far-outlier malalignment in primary TKA, even when accounting for differences in individual surgeon and patient characteristics. Trainee surgeons performed similarly, and certainly not inferiorly, to low-volume non-trainee surgeons. Even among high-volume non-trainees, the best-performing cohort in our study, the proportion of TKA alignment outliers was still high.

Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The implantation of the acetabular cup essentially determines the clinical outcome of total hip arthroplasty. To address this issue, the aim of this study was to build patient-specific instruments (PSIs) with various reference surfaces, followed by in vitro investigations to examine the inter- and intra-operator reliability as well as the overall precision of these patient-specific templates.

Seven human hemi-pelvis specimens were used for this study. After a CT scan, PSIs with different imprint heights were created. The overall precision of the templates and the inter- and intra-operator reliabilities were calculated.

Strong differences in precision between the PSI designs could be observed. The desired orientation of the acetabular cup could be adjusted with a precision of up to 1.55°.

Based on our results, we believe that the application of the PSI-based acetabular cup positioning in total hip arthroplasty procedures can potentially increase the precision of cup placement.

There is no consensus whether the use of the extramedullary femoral cutting guide takes advantage over the intramedullary one in total knee arthroplasty. The aim of this study was to compare the extramedullary femoral alignment guide system with the conventional intramedullary alignment guide system for lower limb alignment, blood loss, and operative time during total knee arthroplasty.

The Medline, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang Chinese Periodical, Google, and reference lists of all the included studies were searched for randomized controlled trials. The following parameters were compared between the extramedullary technique and the intramedullary technique: (1) lower limb coronal alignment, (2) coronal alignment of femoral component, (3) sagittal alignment of femoral component, (4) blood loss, (5) and operation time.

Four randomized controlled trials consisting of 358 knees were included in our study. There was no significant difference between the extramedullary and intramedullary groups for the lower limb coronal alignment (RR = 1.20, 95%CI 0.28~5.21, n.s.), coronal alignment of femoral component (RR = 0.65, 95%CI 0.19~2.22, n.s.), and sagittal alignment of femoral component (RR = 0.73, 95%CI 0.38~1.41, n.s.). A reduced blood loss was associated with the use of the extramedullary guide (MD = -120.34, 95%CI -210.08~-30.59, P = 0.009). No significant difference in operation time was noted between the two groups (MD = 1.41, 95%CI -1.82~4.64, n.s.).

Neither extramedullary nor intramedullary femoral alignment is more accurate than the other in facilitating the femoral cut in total knee arthroplasty. Use of the extramedullary guide results in less blood loss and exhibits a similar operation time as compared with the intramedullary guide.

This article describes the concept and surgical technique of patient-specific total knee arthroplasty. Patient-specific implants and instruments are designed and fabricated based on computed tomography (CT) data of the leg. The disposable patient-specific drill guides and cutting-jigs are manufactured taking into consideration the anatomical and biomechanical axes of the knee joint and mediating the efficient pre-navigation of the osseous saw-cuts, without the need for additional navigation or balancing aids. The surgical plan is made on the basis of the CT data. The implantation technique comprises the following steps: distal femoral resection, tibial resection, balancing and femur preparation, tibia preparation, optional patellar resurfacing, trialling of the test components, and implantation of the final components. By using this patient-specific implant system, which includes not only personalized, single-use instruments, but also individualized implants, the surgeon is able to provide endoprosthetic treatment that broadly restores the patient's own knee anatomy and knee kinematics. Preliminary studies have proven the concept and data on this technology are promising so far; however, like a new implant, they are usually limited. In particular, comparative long-term clinical data are still to come.

The key to a successful knee replacement is restoring normal kinematics with a neutral alignment, thus a hip-knee-ankle (HKA) angle of 180° (within 3° limits). Conventional TKR is proven to have excellent results but relies in extensive visual referencing of bony landmarks. Customised cutting blocks provide accurate bone cuts, also lowering the risk of fat embolism, blood loss and operating time.

We share our experience comparing two different TKA techniques using patient specific instrumentation (PSI) with the Visionaire knee and conventional instrumentation (CVI) from the same system (Genesis II Smith&Nephew). A total number of 80 knees were divided into two equal groups, 40 PSI and 40 CVI respectively, operated between April 2013 and August 2014. One female patient had bilateral TKR during this period, at six months interval, both with the PSI.

All operated knees had varus deformity, with a mean HKA of 168° (PSI) vs 163° (CVI). We used tranexamic acid (double-dose scheme) and suction drains for 48 hours, with a mean blood drainage in the PSI group of 185 ml and Hb levels of 11.2 g/dl at three days post, compared to 260 ml and 10.7 g/dl in the CVI. Mean blood loss was 3.5 g/dl in PSI, and 4.2 g/dl in the CVI. On the long leg standing radiograph at six weeks, all knees were aligned in frontal plane, with simillar HKA values (178.9° PSI vs 178.6° CVI). Bone cuts measured intraoperatively proved to be accurate within a 1 mm limit.

We cannot recommend PSI-TKR for a better outcome. It is an alternative to conventional and computer-assisted TKR, but further studies are needed to evaluate weather surgical or economic benefits may be achieved by choosing customised instruments.

Recently, there is a growing interest in surgical variables that are intraoperatively controlled by orthopaedic surgeons, including lower leg alignment, component positioning and soft tissues balancing. Since more tight control over these factors is associated with improved outcomes of unicompartmental knee arthroplasty and total knee arthroplasty (TKA), several computer navigation and robotic-assisted systems have been developed. Although mechanical axis accuracy and component positioning have been shown to improve with computer navigation, no superiority in functional outcomes has yet been shown. This could be explained by the fact that many differences exist between the number and type of surgical variables these systems control. Most systems control lower leg alignment and component positioning, while some in addition control soft tissue balancing. Finally, robotic-assisted systems have the additional advantage of improving surgical precision. A systematic search in PubMed, Embase and Cochrane Library resulted in 40 comparative studies and three registries on computer navigation reporting outcomes of 474,197 patients, and 21 basic science and clinical studies on robotic-assisted knee arthroplasty. Twenty-eight of these comparative computer navigation studies reported Knee Society Total scores in 3504 patients. Stratifying by type of surgical variables, no significant differences were noted in outcomes between surgery with computer-navigated TKA controlling for alignment and component positioning versus conventional TKA (p = 0.63). However, significantly better outcomes were noted following computer-navigated TKA that also controlled for soft tissue balancing versus conventional TKA (mean difference 4.84, 95 % Confidence Interval 1.61, 8.07, p = 0.003). A literature review of robotic systems showed that these systems can, similarly to computer navigation, reliably improve lower leg alignment, component positioning and soft tissues balancing. Furthermore, two studies comparing robotic-assisted with computer-navigated surgery reported superiority of robotic-assisted surgery in controlling these factors. Manually controlling all these surgical variables can be difficult for the orthopaedic surgeon. Findings in this study suggest that computer navigation or robotic assistance may help managing these multiple variables and could improve outcomes. Future studies assessing the role of soft tissue balancing in knee arthroplasty and long-term follow-up studies assessing the role of computer-navigated and robotic-assisted knee arthroplasty are needed.

Due to the irregular shape of patella and difficulty in identifying its bony landmarks, it can be a challenge for surgeons to accurately and symmetrically perform patellar resurfacing. Three-dimensional (3D) models of 20 patellae were generated from computed tomographic images. Using a computer-assisted preoperative planning technique, customized template designs were developed to guide patellar resurfacing. The patellar models and corresponding templates were produced through rapid prototyping. The accuracy of this technique was assessed after applying the templates on patellar models and cadaver specimens, respectively. Using preoperative planning and predesigned templates, a significant improvement in symmetric patellar resurfacing, with a mean angle of 1.21° mediolateral (ML) obliquity and 1.95° superoinferior (SI) obliquity, was observed compared with the conventional sawguide technique (mean angle of ML and SI was 4.13°, 4.95°, respectively). Additionally, the use of customized templates reproduced the desired preplanned patellar resection. Preoperative planning with 3D imaging and customized templates improved the accuracy of patellar resurfacing in terms of the obliquity and thickness.

A novel customized template designed for patellar resectioning will benefit surgeons in performing patellar resurfacing. This technique will provide accurate patellar resurfacing in clinical practice. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:1798-1803, 2016.

The number of total knee arthroplasty (TKA) procedures continuously increases, with good to excellent results. In the last few years, new surgical techniques have been developed to improve prosthesis positioning. In this context, patient-specific instrumentation is included. The goal of this study was to compare the perioperative parameters and the spatial positioning of prosthetic components in TKA procedures performed with patient-specific instrumentation vs traditional TKA. In this prospective comparative randomized study, 15 patients underwent TKA with 3-dimensional magnetic resonance imaging (MRI) preoperative planning (patient-specific instrumentation group) and 15 patients underwent traditional TKA (non-patient-specific instrumentation group). All patients underwent postoperative computed tomography (CT) examination. In the patient-specific instrumentation group, preoperative data planning regarding femoral and tibial bone resection was correlated with intraoperative measurements. Surgical time, length of hospitalization, and intraoperative and postoperative bleeding were compared between the 2 groups. Positioning of implants on postoperative CT was assessed for both groups. Data planned with 3-dimensional MRI regarding the depth of bone cuts showed good to excellent correlation with intraoperative measurements. The patient-specific instrumentation group showed better perioperative outcomes and good correlation between the spatial positioning of prosthetic components planned preoperatively and that seen on postoperative CT. Less variability was found in the patient-specific instrumentation group than in the non-patient-specific instrumentation group in spatial orientation of prosthetic components. Preoperative planning with 3-dimensional MRI in TKA has a better perioperative outcome compared with the traditional method. Use of patient-specific instrumentation can also improve the spatial positioning of both prosthetic components.

The biological interface between an orthopedic implant and the surrounding host tissue may have a dramatic effect upon clinical outcome. Desired effects include bony ingrowth (osseointegration), stimulation of osteogenesis (osteoinduction), increased vascularization, and improved mechanical stability. Implant loosening, fibrous encapsulation, corrosion, infection, and inflammation, as well as physical mismatch may have deleterious clinical effects. This is particularly true of implants used in the reconstruction of load-bearing synovial joints such as the knee, hip, and the shoulder. The surfaces of orthopedic implants have evolved from solid-smooth to roughened-coarse and most recently, to porous in an effort to create a three-dimensional architecture for bone apposition and osseointegration. Total joint surgeries are increasingly performed in younger individuals with a longer life expectancy, and therefore, the postimplantation lifespan of devices must increase commensurately. This review discusses advancements in biomaterials science and cell-based therapies that may further improve orthopedic success rates. We focus on material and biological properties of orthopedic implants fabricated from porous metal and highlight some relevant developments in stem-cell research. We posit that the ideal primary and revision orthopedic load-bearing metal implants are highly porous and may be chemically modified to induce stem cell growth and osteogenic differentiation, while minimizing inflammation and infection. We conclude that integration of new biological, chemical, and mechanical methods is likely to yield more effective strategies to control and modify the implant-bone interface and thereby improve long-term clinical outcomes.

The accelerometer-based system is a portable surgical navigation system for TKA that does not require the use of a large computer console for registration and alignment feedback as required in computer-assisted surgery (CAS). The purpose of this prospective study was to determine the accuracy of the accelerometer-based system in the tibial component positioning and also to evaluate clinical outcomes.

Between December 2011 and July 2012, a total of 53 consecutive patients with primary gonarthrosis were prospectively enrolled for unilateral TKA using a handheld surgical navigation system to perform the tibial resection. Pre-operatively and postoperatively, patients were asked to fill out a visual analogue scale for pain (VAS) and a knee injury and osteoarthritis outcome score (KOOS). Standing antero-posterior (AP) hip-knee-ankle (HKA) and lateral knee-to-ankle radiographs were performed to determine the varus/valgus alignment and the posterior slope of the tibial components relative to the mechanical axis.

The mean duration of follow-up was 23 months. Average preoperative VAS was 8.3 ± 0.67, which significantly improved to a mean 1.2 ± 0.57 at final follow up (P < 0.001). All scores significantly increased compared with pre-operative scores, except for the KOOS sport component (P = 0.075) and quality of life (P = 0.19). Intra-operatively, the average reading provided by the system with regard to varus/valgus alignment before performing the tibial resection was 0.55° ± 0.43. The average postoperative radiographic alignment of the tibial component in the coronal plane was 0.65° ± 0.59 of deviation by the ideal alignment (P > 0.05).

This study demonstrates that the OrthAlign navigation system combines the accuracy of the computer-assisted surgery systems with the ease of use and familiarity of the traditional instruments while avoiding the drawbacks of the CAS technique and disadvantages of conventional IM femoral alignment systems. The system could demonstrate an improvement in the incidence of outliers in final coronal alignment, as compared with a patient-specific cutting guide.

The aim of this study was to compare radiological results of total knee arthroplasties (TKAs) performed with patient-specific computed tomography (CT)-based instrumentation and conventional technique. The main study hypothesis was that CT-based patient-specific instrumentation (PSI) increases the accuracy of TKA.

A prospective, randomized controlled trial was carried out between January and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients operated on with the aid of the Signature CT-based implant positioning system. The control group consisted of 60 patients operated on using conventional instrumentation. The radiographic evaluation of implant positioning and overall coronal alignment was performed 12 months after the surgery by using standing anteroposterior radiographs of the entire lower limb and standard lateral radiographs.

Of the 112 patients initially enrolled for the study, 95 were included in the subsequent analyses. There were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment, except for frontal tibial component positioning. For this parameter, better results were obtained in the control group, with borderline statistical significance.

Our study did not reveal superiority of the CT-based PSI system over conventional instrumentation. Further high-quality investigations of patient-specific systems are absolutely indispensable to assess their utility for TKA. In our opinion, the surgeon applying PSI technology is required to have advanced knowledge and considerable experience with the conventional method.