Introduction.
Introduction. There is increasing pressure on healthcare providers to demonstrate competitiveness in quality, patient outcomes and cost. Robotic and computer-assisted total knee arthroplasty (TKA) have been shown to be more accurate than conventional TKA, thereby potentially improving quality and outcomes, however these technologies are usually associated with longer procedural times and higher costs for hospitals. The aim of this study was to determine the surgical efficiency, learning curve and early patient satisfaction of
We sought to evaluate the early post-operative active range-of-motion (AROM) between
Introduction. Total knee arthroplasty (TKA) is a well established treatment option for patients with end stage osteoarthritis. Conventional TKA with manual instruments has been shown to be a cost effective and time efficient surgery. While robotic-assisted operative systems have been shown to have benefits in surgical accuracy, they have also been reported to have longer surgical times. The purpose of this work was to determine surgical time and learning curve for a novel
Introduction. Surgical outcome analysis has shifted from surgeon- to patient-reported outcome measures (PROM). High rates of dissatisfaction (13–20%) in PROM after TKA have persisted despite significant advances in pain-management, implant design and introduction of newer surgical techniques. The NAVIO
The use of robotics in total joint arthroplasty is the latest in a long list of expensive technologies that promise multiple positive outcomes, but come with an expensive price tag. In the last decade alone we've seen the same claims for navigation and patient specific instruments and implants. There are various current systems available including a robotic arm, robotic-guided cutting jigs and robotic milling systems. For robotics to be widely adopted it will need to address the following concerns, which as of 2017 it has not. 1). Cost - Very clearly the robotic units come with a significant price tag. Perhaps over time, like other technologies, they will reduce, but at present they are prohibitive for most institutions. 2). Outcomes - One could perhaps justify the increased costs if there was compelling evidence that either outcomes were improved or revision rates reduced. Neither of these has been proved in any type of randomised trial or registry captured data. As with any new technology one must be wary of the claims superseding the results. In 2017 the jury is still out on the cost vs. benefit of
Introduction/Aim. The NAVIO
Introduction. Robotic systems have been used in TKA to add precision, although few studies have evaluated clinical outcomes. We report on early clinical results evaluating patient reported outcomes (PROs) on a series of
Total knee arthroplasty is a successful procedure with good long-term results. Studies indicate that 15% – 25% of patients are dissatisfied with their total knee arthroplasty. In addition, return to sports activities is significantly lower than total hip arthroplasty with 34% – 42% of patients reporting decreased sports participation after their total knee arthroplasties. Poor outcomes and failures are often associated with technical errors. These include malalignment and poor ligament balancing. Malalignment has been reported in up to 25% of all revision knee arthroplasties, and instability is responsible for over 20% of failures. Most studies show that proper alignment within 3 degrees is obtained in only 70% – 80% of cases. Navigation has been shown in many studies to improve alignment. In 2015, Graves examined the Australian Joint Registry and found that computer navigated total knee arthroplasty was associated with a reduced revision rate in patients under 65 years of age. Navigation can improve alignment, but does not provide additional benefits of ligament balance. Robotic-assisted surgery can assist in many of the variables that influence outcomes of total knee arthroplasty including: implant positioning, soft tissue balance, lower limb alignment, proper sizing. The data on robotic-assisted unicompartmental arthroplasty is quite promising. Cytech showed that femoral and tibial alignment were both significantly more accurate than manual techniques with three times as many errors with the manually aligned patients. Pearle, et al. compared the cumulative revision rate at two years and showed this rate was significantly lower than data reported in most unicompartmental series, and lower revision rates than both Swedish and Australian registries. He also showed improved satisfaction scores at two years. Pagnano has noted that optimal alignment may require some deviation from mechanically neutral alignment and individualization may be preferred. This is also likely to be a requirement of more customised or bi-cruciate retaining implant designs. The precision of robotic surgery may be necessary to obtain this individualised component alignment. While robotic total knee arthroplasty requires further data to prove its value, more precise alignment and ligament balancing is likely to lead to improved outcomes, as Pearl, et al. and the Australian registry have shown. While it is difficult to predict the future at this time, I believe
Introduction/Aim. Mid-flexion instability is a well-documented, but often poorly understood cause of failure of
Arthrofibrosis remains a dominant post-operative complication and reason for returning to the OR following total knee arthroplasty. Trauma induced by ligament releases during TKA soft tissue balancing and soft tissue imbalance are thought to be contributing factors to arthrofibrosis, which is commonly treated by manipulation under anesthesia (MUA). We hypothesized that a robotic-assisted ligament balancing technique where the femoral component position is planned in 3D based on ligament gap data would result in lower MUA rates than a measured resection technique where the implants are planned based solely on boney alignment data and ligaments are released afterwards to achieve balance. We also aimed to determine the degree of mechanical axis deviation from neutral that resulted from the ligament balancing technique. Methods. We retrospectively reviewed 301 consecutive primary TKA cases performed by a single surgeon. The first 102 consecutive cases were performed with a femur-first measured resection technique using computer navigation. The femoral component was positioned in neutral mechanical alignment and at 3° of external rotation relative to the posterior condylar axis. The tibia was resected perpendicular to the mechanical axis and ligaments were released as required until the soft tissues were sufficiently balanced. The subsequent 199 consecutive cases were performed with a tibia-first ligament balancing technique using a
We introduce a novel active tensioning system that can be used for dynamic gap-based implant planning as well as for assessment of final soft tissue balance during implant trialing. We report on the concept development and preliminary findings observed during early feasibility testing in cadavers with two prototype systems. System description. The active spacer (fig 1) consists of a motorized actuator unit with integrated force sensors, independently actuated medial and lateral upper arms, and a set of modular attachments for replicating the range of tibial baseplate and insert trial sizes. The spacer can be controlled in either force or position (gap) control and is integrated into the OMNIBotics. TM.
Introduction. Component position and overall limb alignment following total knee arthroplasty (TKA) have been shown to influence prosthetic survivorship and clinical outcomes.
Valgus deformity in an end stage osteoarthritic knee can be difficult to correct with no clear consensus on case management. Dependent on if the joint can be reduced and the degree of medial laxity or distension, a surgeon must use their discretion on the correct method for adequate lateral releases. Robotic assisted (RA) technology has been shown to have three dimensional (3D) cut accuracy which could assist with addressing these complex cases. The purpose of this work was to determine the number of soft tissue releases and component orientation of valgus cases performed with RA total knee arthroplasty (TKA). This study was a retrospective chart review of 72 RATKA cases with valgus deformity pre-operatively performed by a single surgeon from July 2016 to December 2017. Initial and final 3D component alignment, knee balancing gaps, component size, and full or partial releases were collected intraoperatively. Post-operatively, radiographs, adverse events, WOMAC total and KOOS Jr scores were collected at 6 months, 1 year and 2 year post-operatively.Introduction
Methods
Studies have shown that dissatisfaction following TKA may stem from poor component placement and iatrogenic factors related to variability in surgical execution. A CT-based robotic assisted system (RA) allows surgeons to dynamically balance the joint prior to bone resection. This study aimed to determine if this system could improve TKA planning, reduce soft tissue releases, minimize bone resection, and accurately predict component size in varus knee. Four hundred and seventy four cases with varus deformity undergoing primary RATKA were enrolled in this prospective, single center and surgeon study. Patient demographics and intraoperative surgical details were collected. Initial and final 3-dimensional alignment, component position, bone resection depths, use of soft tissue releases, knee balancing gaps, and component size were collected intraoperatively. WOMAC and KOOS Jr. scores were collected 6 months, and 1 year postoperatively. Descriptive statistics were applied to determine the changes in these parameters between initial and final values.Introduction
Method
Component position and overall limb alignment following Total Knee Arthroplasty (TKA) have been shown to influence device survivorship and clinical outcomes. However current methods for measuring post-operative alignment through 2D radiographs and CTs may be prone to inaccuracies due to variations in patient positioning, and certain anatomical configurations such as rotation and flexion contractures. The purpose of this paper is to develop a new vector based method for overall limb alignment and component position measurements using CT. The technique utilizes a new mathematical model to calculate prosthesis alignment from the coordinates of anatomical landmarks. The hypothesis is that the proposed technique demonstrated good accuracy to surgical plan, as well as low intra and inter-observer variability. This study received institutional review board approval. A total of 30 patients who underwent robotic assisted TKA (RATKA) at four different sites between March 2017 and January 2018 were enrolled in this prospective, multicenter, non-randomized clinical study. CT scans were performed prior to and 4–6 weeks post-operatively. Each subject was positioned headfirst supine with the legs in a neutral position and the knees at full extension. Three separate CT scans were performed at the anatomical location of the hip, knee, and ankle joint. Hip, knee, and ankle images were viewed in 3D software and the following vertices were generated using anatomical landmarks: Hip Center (HC), Medial Epicondyle Sulcus (MES), Lateral Epicondyle (LE), Femur Center (FC), Tibia Center (TC), Medial Malleolus (MM), Lateral Malleolus (LM), Femur Component Superior (FCS), Femur Component Inferior (FCI), Coronal Femoral Lateral (CFL), Coronal Femoral Medial (CFM), Coronal Tibia Lateral (CTL), and Coronal Tibia Medial (CTM). Limb alignment and component positions were calculated from these vertices using a new mathematical model. The measurements were compared to the surgeons’ operative plan and component targeted positions for accuracy analysis. Two analysts performed the same measurements separately for inter-observer variability analysis. One of the two analysts repeated the measurements at least 30 days apart to assess intra-observer variability. Correlation analysis was performed on the intra-observer analysis, while Bland Altman analysis was performed on the inter-observer analysis.Introduction
Methods
Innovations in surgical robotics and navigation have significantly improved implant placement accuracy in total knee arthroplasty (TKA). However, many comparative studies have not been shown to substantially improve revision rates or other clinical outcome scores. We conducted a simulation study based on the reported distribution of patient-specific characteristics and estimated potential effect of coronal plane alignment (CPA) on risk of revision to evaluate the hypothesis that most published study designs in this area have been too underpowered to detect improvements in revision rates. To model previously reported studies, we generated a series of simulated TKA patient populations, assigning each patient a set of patient-specific factors (age at index surgery, BMI, and sex (Fig.1a)), as well as one surgeon-controlled factor (CPA) (Fig.1b) based on registry data and published literature. We modelled the survival probability for an individual patient at time To evaluate power associated with a study design, we ran a Monte Carlo simulation generating 10,000 simulated populations of ten different cohort sizes. We divided the patient population into two groups: one group was assigned CPAs governed by the precision of a navigated/robotic approach (σ=1.5°), and the other CPAs governed by the precision of a conventional approach (σ=3°). We then simulated the time to failure for each patient, computed the corresponding Kaplan-Meier survival curves, and applied a Log-Rank test to each study to test for statistical difference. From the 10,000 simulations associated with each cohort size, we determined the percentage of simulated studies that found a statistically significant difference at each time point.Introduction
Methods
Semi-active robots can improve the accuracy and precision of total knee arthroplasty (TKA). The surgical efficiency of the recently introduced NAVIO robotic-assisted (RA-TKA) surgery was assessed in this study to define: (1) the time commitment for RA-TKA; (2) the learning curve for RA-TKA; and (3) to compare RA-TKA surgical time commitment to conventional, instrumented TKA (CI-TKA). Beginning in May 2017, the first 100 patients undergoing NAVIO RA-TKA were registered pre-operatively. Operative time, defined as the time from surgical skin incision to capsular closure, was recorded. Exclusion criteria were cases in which surgical time was not recorded. During the same study period, surgical case times for fifty cases of CI-TKA procedures were also assessed. Baseline data, including age, gender, BMI, range of motion, was recorded for all subjects. Surgical and anesthetic technique, multi-modality pain management protocol, and post-operative mobilization was consistent for all patients enrolled in the study.Introduction
Materials and Methods
Gap balancing technique aims to achieve equal and symmetric gap at full extension and in flexion; however, little is known about the connection between the native and the replaced knee gaps. In this study, a novel robotic assisted ligament tensioning tool was used to measure the pre- and post- operative gaps to better understand their relationship when aiming for balance gaps in flexion and extension. The accuracy of a prediction algorithm for the post-operative gaps based on the native gap and implant alignment was evaluated in this study. The medial and lateral gap were smallest at full extension. The native gaps increase with flexion until 30 degrees where they plateaued for the remaining flexion range. The native lateral gap was larger than the medial gap throughout the flexion range. Planning for equal gaps at extension and flexion resulted with tightest gaps at these angle; however, the gaps in mid-flexion were 3–4 mm larger. Good agreement was observed between the post-operative results and the predicted gas from the software algorithm. The results showed that the native gaps are neither symmetric nor equal. In addition, aiming for equal gaps reduces the variation at these angles but could result in mid- flexion laxity. Advanced robotics-assisted instrumentation can aid in evaluation of soft-tissue and help in surgical planning of TKA. This allows the surgeon to achieve the targeted outcome as well as record the final implant tension to correlate with clinical outcomes.
We evaluated the utility of imageless computer-navigation coupled with a miniature robotic-cutting guide for managing large deformities in TKA. We asked what effect did severe pre-operative deformities have on post-operative alignment and surgery time using the system. We also report on the early functional outcomes of this group of patients. This was a retrospective cohort study of 128 TKA's performed by a single surgeon (mean age: 71y/o [range 53–93], BMI: 31.1 [20–44.3], 48males). Patients were stratified into three groups according to their pre-operative coronal plane deformity: Neutral or mild deformity <10((baseline group); Severe varus ≥10(; severe valgus ≥10(; and according to the degree of flexion contracture: Neutral or mild flexion from −5(hyperextension to 10(flexion (baseline group); hyperextension ≤−5(, and severe flexion ≥10. (The degree of deformity and final postoperative alignment achieved was measured using computer navigation in all patients and analysed using multivariate regression. The APEX CR/Ultra Knee System (OMNIlife Science, Inc.) was used with the PRAXIM Navigation system in all cases. A students t-test was used to compare pre- and post-operative (3–6 months) Knee Society Scores (KSS) and Knee Functional Scores (KSSF) for all patients.Introduction
Methods