Achieving a balanced joint with neutral alignment is not always possible in total knee arthroplasty (TKA). Intra-operative compromises such as accepting some joint imbalance, non-neutral alignment or soft-tissue release may result in worse patient outcomes, however, it is unclear which compromise will most impact outcome. In this study we investigate the impact of post-operative soft tissue balance and component alignment on postoperative pain. 135 patients were prospectively enrolled in robot assisted TKA with a digital joint tensioning tool (OMNIBotics with BalanceBot, Corin USA) (57% female; 67.0 ± 8.1 y/o; BMI: 31.9 ± 4.8 kg/m2). All surgeries were performed with a PCL sacrificing tibia or femur first techniques technique, using CR femoral components and a deep dish tibial insert (APEX, Corin USA). Gap measurements were acquired under load (average 80 N) throughout the range of motion during trialing with the tensioning tool inserted in place of the tibial trial. Component alignment parameters and post-operative joint gaps throughout flexion were recorded. Patients completed 1-year KOOS pain questionnaires. Spearman correlations and Mann-Whitney-U tests were used to investigate continuous and categorical data respectively. All analysis performed in R 3.5.3.Introduction
Methods
Soft-tissue balancing methods in TKA have evolved from surgeon feel to digital load-sensing tools. Such techniques allow surgeons to assess the soft-tissue envelope after bone cuts, however, these approaches are ‘after-the-fact’ and require soft-tissue release or bony re-cuts to achieve final balance. Recently, a robotic ligament tensioning device has been deployed which characterizes the soft tissue envelope through a continuous range-of-motion after just the initial tibial cut, allowing for virtual femoral resection planning to achieve a targeted gap profile throughout the range of flexion (figure-1). This study reports the first early clinical results and patient reported outcomes (PROMs) associated with this new technique and compares the outcomes with registry data. Since November 2017, 314 patients were prospectively enrolled and underwent robotic-assisted TKA using this surgical technique (mean age: 66.2 ±8.1; females: 173; BMI: 31.4±5.3). KOOS/WOMAC, UCLA, and HSS-Patient Satisfaction scores were collected pre- and post-operatively. Three, six, and twelve-month assessments were completed by 202, 141, and 63 patients, respectively, and compared to registry data from the Shared Ortech Aggregated Repository (SOAR). SOAR is a TJA PROM repository run by Ortech, an independent clinical data collection entity, and it includes data from thousands of TKAs from a diverse cross-section of participating hospitals, teaching institutions and clinics across the United States and Canada who collect outcomes data. PROMs were compared using a two-tailed t-test for non-equal variance.Introduction
Methods
Soft tissue releases are often required to correct deformity and achieve gap balance in total knee arthroplasty (TKA). However, the process of releasing soft tissues can be subjective and highly variable and is often perceived as an ‘art’ in TKA surgery. Releasing soft tissues also increases the risk of iatrogenic injury and may be detrimental to the mechanically sensitive afferent nerve fibers which participate in the regulation of knee joint stability. Measured resection TKA approaches typically rely on making bone cuts based off of generic alignment strategies and then releasing soft tissue afterwards to balance gaps. Conversely, gap-balancing techniques allow for pre-emptive adjustment of bone resections to achieve knee balance thereby potentially reducing the amount of ligament releases required. No study to our knowledge has compared the rates of soft tissue release in these two techniques, however. The objective of this study was, therefore, to compare the rates of soft tissue releases required to achieve a balanced knee in tibial-first gap-balancing versus femur-first measured-resection techniques in robotic assisted TKA, and to compare with release rates reported in the literature for conventional, measured resection TKA [1]. The number and type of soft tissue releases were documented and reviewed in 615 robotic-assisted gap-balancing and 76 robotic-assisted measured-resection TKAs as part of a multicenter study. In the robotic-assisted gap balancing group, a robotic tensioner was inserted into the knee after the tibial resection and the soft tissue envelope was characterized throughout flexion under computer-controlled tension (fig-1). Femoral bone resections were then planned using predictive ligament balance gap profiles throughout the range of motion (fig-2), and executed with a miniature robotic cutting-guide. Soft tissue releases were stratified as a function of the coronal deformity relative to the mechanical axis (varus knees: >1° varus; valgus knees: >1°). Rates of releases were compared between the two groups and to the literature data using the Fischer's exact test.Introduction
Methods
Achieving good ligament balance in total knee arthroplasty (TKA) is essential to prevent early failure and revision surgery. Poor balance and instability are well-defined, however, an ideal ligament balance target across all patients is not well-understood. In this study we investigate the achieved ligament balance using an imageless, intra-operative dynamic balancing tool and its relation to patient reported outcomes. A prospective, multi-surgeon, multi-center study investigated the use of a dynamic ligament-balancing tool in combination with a robotic-assisted navigation platform using the APEX knee (OMNI-Corin, Raynham MA). After all resections, the femoral trial and a computer-controlled tensioning device in place of the tibial tray was inserted into the knee joint. The difference in medial and lateral (ML) gaps when balancing the knee under constant load at extension (10°), mid-flexion (30°) and flexion (90°) was captured. Patients completed the KOOS questionnaire at 3 months ± 2 weeks post-surgery and considered the past 7 days as a timeframe for responses. Pearson's correlation was used to determine linear correlations between factors and ANOVA tests were used to determine differences in categorical data.Background
Methods
Achieving a well-balanced midflexion and flexion soft tissue envelope is a major goal in Total Knee Arthroplasty (TKA). The definition of soft tissue balance that results in optimal outcomes, however, is not well understood. Studies have investigated the native soft tissue envelope in cadaveric specimen and have shown loosening of the knee in flexion, particularly on the lateral side. These methods however do not reflect the post TKA environment, are invasive, and not appropriate for intra-operative use. This study utilizes a digital gap measuring tool to investigate the impact of soft tissue balance in midflexion and flexion on post-operative pain. A prospective multicenter multi-surgeon study was performed in which patients underwent TKA with a dynamic ligament-balancing tool in combination with a robotic-assisted navigation platform. All surgeries were performed with APEX implants (Corin Ltd., USA) using a variety of tibia and femur first techniques. Gap measurements were acquired under load (average 80 N) throughout the range of motion during trialing with the balancing tool inserted in place of the tibial trial. Patients completed KOOS pain questionnaires at 3months±2weeks post-op. Linear correlations were investigated between KOOS pain and coronal gap measurements in midflexion (30°–60°) and flexion (>70°). T-tests were used to compare outcomes between categorical data.Introduction
Methods
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 robotic-assisted TKA (RAS-TKA) patients, and compare scores to those reported in the literature. We prospectively consented and enrolled 106 patients undergoing RAS-TKA by a single surgeon performing a measured-resection femur-first technique using a miniature bone-mounted robotic system. Patients completed a KOOS, New Knee Society Score (2011 KSS) and a Veterans RAND-12 (VR-12) pre-operatively and at 3, 6 and 12 months (M) post- operatively. At the time of publication 104, 101, and 78 patients had completed 3M, 6M, and 12M PROs, respectively. Changes in the five KOOS subscales (Pain, Symptoms, Activities of Daily Living (ADL), Sport and recreation function (Sport/Rec) and Knee-related Quality of Life (QOL)) were compared to available literature data from FORCE – TJR, a large, prospective, national cohort of TJR patients enrolled from diverse high-volume centers and community orthopaedic practices in the U.S, as well as to individual studies reporting on conventional (CON-TKA) and computer-assisted (CAS- TKA) at 3M, and on conventional TKA at 6M. The 2011 KSS is a validated method for quantifying patient's expectations and satisfaction with their TKA procedure. Improvements in the 2011 KSS were compared with literature data at 6M post-operatively.Introduction
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.
Knee joint instability, which is a primary reason for TKA revision surgeries, is typically caused by deficiency in the knee ligaments [1, 2]. Managing ligament deficiency and restoring joint stability continues to be one of the greatest challenges for revision surgeries [3]. To treat such patients, revision TKA implants frequently incorporate a constrained post and cam mechanism to provide enhanced varus-valgus constraint to supplement the function of the collateral ligaments. The aim of this study was to evaluate knee kinematics during a weight bearing deep knee bend for both a primary TKA system and its complimentary revision system. The hypothesis of the study was that the revision tibial insert would demonstrate improved knee stability, in the form of a reduced range of motion under out-of-plane loading, when compared to the primary system Eight cadaveric knees (age: 59±10 years, BMI 23.3±3.5) were implanted with an ATTUNE™ revision femoral component and a primary posterior stabilized tibial component. Each knee was mounted and aligned into the Kansas Knee Simulator (Fig. 1) [4]. A deep knee bend was performed between 10° and 110° flexion with no out-of-plane loading. Additional deep knee bends were performed with constant 6Nm external and 6Nm internal torques about the tibial long axis, and with 40N medial and 40N lateral loads applied at the ankle sled. The 40N medial and 40N lateral loads produce approximately 15Nm adduction and abduction moments at the knee, respectively. The primary tibial insets were then replaced with revision tibial inserts from the same TKA system and the deep knee bend cycles were repeated. The revision tibial inserts included a larger tibial post intended to constrain the varus-valgus rotation of the knee. The change in knee kinematics of the revision tibial insert compared to the primary insert was calculated and student t-tests were performed to identify significant differences between the two tibial insert types for each loading condition.Introduction
Methods
Tibiofemoral constraint in patients with total knee replacements (TKR) is dependent on both implant geometry and the surrounding soft tissue structures. Choosing more highly constrained geometries can reduce the contribution of soft tissue necessary to maintain joint stability [1]. Often when knee revision surgeries are required, the soft tissue and bone are compromised leading to the use of more constrained implants to ensure knee stability [2]. The current study quantifies the differences in varus-valgus (VV) and internal-external (IE) constraint between two types of total knee revision systems: SIGMA® TC3© and ATTUNE® REVISION. Nine cadaveric knees (7 male, age 64.0 ± 9.8 years, BMI 26.28 ± 4.92) were implanted with both fixed-bearing SIGMA TC3 and ATTUNE REVISION knee systems. Five knees received the TC3 implant first, while the remaining 4 received the ATTUNE implant first. The knees were mounted in an inverted position, and a six degree-of-freedom force-torque sensor (JR3, Woodland, CA) was rigidly secured to the distal tibia (Fig. 1). A series of manual manipulations applying IE and VV torques was performed through the flexion range [3]. Each specimen was then revised to the alternate revision system, and the manual manipulations were repeated. Joint loads were calculated, and tibiofemoral kinematics were described according to the Grood-Suntay definition [4]. VV and IE kinematics were calculated as a function of flexion angle, VV torque, and IE torque as has been described previously [3]. The knees were analysed at ±6 Nm VV and ±4 Nm IE, and the kinematics were normalized to the zero load path. A paired t-test (p < .05) was employed to identify significant differences between the kinematics of the two knee systems at 10º flexion increments.Introduction
Methods
During primary total knee arthroplasty (TKA), surgeons occasionally encounter compromised bone and fixation cannot be achieved using a primary femoral component. Revision knee replacement components incorporate additional features to improve fixation, such as modular connection to sleeves or stems, and feature additional varus-valgus constraint in the post-cam mechanism to compensate for soft tissue laxity. The revision femoral component can be used in place of the primary femur to address fixation challenges; however, it is unclear if additional features of the revision femoral components adversely affect knee kinematics when compared to primary TKA components. The objective of this study was to compare weight-bearing tibiofemoral and patellofemoral kinematics between primary and revision femoral component with the primary tibial insert for a single knee replacement system. The hypothesis of the study was that kinematics for revision femoral components will be similar to kinematics of the primary femoral components Eight cadaveric knees (age: 59±10 years, BMI 23.3±3.5) were implanted with a primary TKA system (ATTUNE™ Posterior Stabilized Total Knee Replacement System). Each knee was mounted and aligned in the Kansas Knee Simulator (Fig. 1) [1]. A deep knee bend was performed which flexed the knee from full extension to 110° flexion, while the medial-lateral translation, internal-external, and varus-valgus rotations at the ankle were unconstrained. The femoral component was then replaced with a revision femoral component of the same TKA system, articulating on the same primary insert component, and the deep knee bend was repeated. The translations of the lowest points (LP) of the medial and lateral femoral condyles along the superior-inferior axis of the tibia were calculated. In addition, tibiofemoral and patellofemoral kinematics were calculated for each cycle based on the Grood-Suntay coordinate system [2] [1]. The change in LP and patellofemoral kinematics from the primary to revision femurs were calculated. Student t-tests were performed at 5° increments of knee flexion to identify significant differences between the two implant types.Introduction
Methods
Quadriceps weakness, which is often reported following total knee arthroplasty (TKA), affects patients' abilities to perform activities of daily living [1]. Implant design features, particularly of the patella-femoral joint, influence the mechanical advantage of the extensor mechanism. This study quantifies the changes in extensor mechanism moment arms due to different patellar resurfacing options during TKA. Posterior-stabilized TKR surgery was performed on seven cadaveric knees which were subsequently mounted in the Kansas Knee Simulator (KKS) [2]. A dynamic physiological squat was simulated between 5° and 80° knee flexion at 50% body weight while knee kinematics, including the lines of action of the rectus femoris (RF) muscle and patellar tendon (PT), were recorded using an optical tracking system. The simulation was performed after three patella treatment options: 1) leaving the native patella Unresurfaced, 2) resurfaced with a medialized Dome patella, and 3) resurfaced with a medialized Anatomic patella which included a conforming lateral facet. Moment arms from the tibio-femoral helical axis to the line of action of the PT and the RF were calculated for each patella condition.Introduction
Methods
