Active robotics for total knee Arthroplasty (TKA) uses a CAD-CAM approach to plan the correct size and placement of implants and to surgically achieve planned limb alignment. The TSolution One Total Knee Application (THINK Surgical Inc., Fremont, CA) is an open-implant platform, CT-based active robotic surgical system. A multi-center, prospective, non-randomized clinical trial was performed to evaluate safety and effectiveness of robotic-assisted TKA using the TSolution One Total Knee Application. This report details the findings from the IDE. Patients had to be ≥ 21 years old with BMI ≤ 40, Kellgren-Lawrence Grade ≥ 3, coronal deformity ≤ 20°, and sagital flexion contracture ≤ 15° to participate. In addition to monitoring all adverse events (AE), a pre-defined list of relevant major AEs (medial collateral ligament injury, extensor mechanism disruption, neural deficit, periprosthetic fracture, patellofemoral dislocation, tibiofemoral dislocation, vascular injury) were specifically identified to evaluate safety. Bleeding complications were also assessed. Malalignment rate, defined as the percentage of patients with more than a ± 3° difference in varus-valgus alignment from the preoperative plan, was used to determine accuracy of the active robotic system. Knee Society Scores (KSS) and Short Form 12 (SF-12) Health Surveys were assessed as clinical outcome measures. Results were compared to published values associated with manual TKA.Introduction
Methods
Successful total knee arthroplasty (TKA) is predicated on accurate bony resection, mechanical alignment and component positioning. An active robotic TKA system is designed to achieve reliable and accurate bony resection based upon a preoperatively developed surgical plan. Surgical resections are executed intra-operatively according to this pre-operative plan. The goal of this study was to determine the accuracy of final implant positioning and alignment using this active robotic device, as well as its early clinical outcomes. An FDA prospective study under investigational device exemption was conducted from 2017–2018. Pre-operative CT scans were used to create a pre-operative plan using the TSolution One? Surgical System (THINK Surgical, Inc). TKA was performed using a standard approach, with planned and robotically executed femoral and tibial resections. Subjects completed 3-month follow-up with post-operative CT scans. A validated method was used to compare pre- and post-operative CT scans to determine differences between planned and achieved implant position. Femoral and tibial component sizing, and mean differences in implant position and alignment were compared. Short Form 12 Physical (PCS) and Mental Component Summary (MCS) scores as well as Knee Society (Objective and Functional) scores at 12 weeks post-operatively were compared with pre-operative scores. Paired-sample t-tests were used for comparisons.Objectives
Materials and Methods
Despite that computer-assisted orthopaedic surgery (CAOS) has been shown to offer increased accuracy to the bony resections compared to the conventional techniques [1], previous studies of CAOS have mostly focused on alignment outcomes based on a small number of patients [1]. Although several recent meta-analyses on the CAOS outcomes have been reported [2], these analyses did not differentiate between systems, while system-dependency has been reported to influence alignment parameters [3]. To date, no study has benchmarked a specific CAOS system based on a large number of clinical cases. The purpose of this study is to assess the accuracy and precision of bony resection in more than 4000 cases using a specific contemporary CAOS system. Technical logs of 4292 TKAs performed between October 2012 and January 2016 using a contemporary CAOS system (ExactechGPS, Blue-Ortho, Grenoble, FR) were analyzed. The analyses were performed on: 1) planned resection, defined by the surgeon prior to the bone cuts. These parameters serve as inputs for the CAOS guidance; and 2) Checked resection, defined as digitalization of the actual resection surfaces by manually pressing an instrumented checker onto the bony cuts. Deviations in alignment and resection depths (on the referenced side) between planned and checked resections were calculated in coronal and sagittal planes for both tibia and femur (planned vs checked).INTRODUCTION
Materials and Methods
Although several meta-analyses have been performed on total knee arthroplasty (TKA) using computer-assisted orthopaedic surgery (CAOS) [1], understanding the inter-site variations of the surgical profiles may improve the interpretation of the results. Moreover, information on the global variations of how TKA is performed may benefit the development of CAOS systems that can better address geographic-specific operative needs. With increased application of CAOS [2], surgeon preferences collected globally offers unprecedented opportunity to advance geographic-specific knowledge in TKA. The purpose of this study was to investigate geographic variations in the application of a contemporary CAOS system in TKA. Technical records on more than 4000 CAOS TKAs (ExactechGPS, Blue-Ortho, Grenoble, FR) between October 2012 and January 2016 were retrospectively reviewed. A total of 682 personalized surgical profiles, set up based on surgeon's preferences, were reviewed. These profiles encompass an extensive set of surgical parameters including the number of steps to be navigated, the sequence of the surgical steps, the definition of the anatomical references, and the parameters associated with the targeted cuts. The profiles were compared between four geographic regions: United States (US), Europe (EU), Asia (AS), and Australia (AU) for cruciate-retaining (CR) and posterior-stabilized (PS) designs. Clinically relevant statistical differences (CRSD, defined as significant differences in means ≥1°/mm) were identified (significance defined as p<0.05).INTRODUCTION
Materials and Methods
Studies have reported that only 70–80% of the total knee arthroplasty (TKA) cases using conventional instruments can achieve satisfactory alignment (within ±3° of the mechanical axis). Computer-assisted orthopaedic surgery (CAOS) has been shown to offer increased accuracy and precision to the bony resections compared to conventional techniques [1]. As the early adopters champion the technology, reservation may exist among new CAOS users regarding the ability of achieving the same results. The purpose of this study was to investigate if there are immediate benefits in the accuracy and precision of achieving surgical goals for the novice surgeons, as compared to the experienced surgeons, by using a contemporary CAOS system. Two groups of surgeons were randomly selected from TKAs between October 2012 and January 2016 using a CAOS system (ExactechGPS, Blue-Ortho, Grenoble, FR), including:
All the surgeries from the INTRODUCTION
Materials and Methods
Total knee arthroplasty (TKA) is a common procedure with good success rates. The literature shows resection accuracy plays a crucial role in device longevity1. Computer guidance is used by some surgeons to enhance accuracy. This study reports on a continuous series of Optetrak knee prostheses (Exactech Inc., FL, USA) implanted by three senior surgeons between October 2010 and December 2013. 324 TKA were implanted at the Joseph Ducuing Hospital, Toulouse, France (Site 1), the Cleveland Clinic, Cleveland, OH, USA (Site 2) and the Riverview Hospital, Noblesville, IN, USA (Site 3) using Exactech GPS (Blue-Ortho, Grenoble, FR), a new computer-assisted guidance system. Each centre in this study used different surgical profiles defined specifically for their surgeical preferences. Planned tibial and femoral cuts were compared to actual cuts digitised using GPS. Operating time was analyzed and post-operative leg alignment was compared to pre-operative. The mean error between planned and digitised proximal tibial cuts was 0.06°±0.89 of valgus and 0.53°±0.90 of anterior slope for Site 1, 0.18°±0.85 of varus and 0.25°±1.18 of posterior slope for Site 2, and 0.02°±0.51 of valgus and 0.60°±1.15 of anterior slope for Site 3. The mean error between planned and digitised femoral distal cuts was 0.14°±0.85 of valgus and 0.49°±0.93 of flexion for Site 1, 0.15°±0.96 of varus and 0.04°±1.54 of extension for Site 2, and 0.09°±0.54 of varus and 0.48°±1.21 of extension for Site 3. Average operating time was 29 minutes for Site 1, 39 minutes for Site 2, and 33 minutes for Site 3. Post-operative Hip-Knee-Ankle angle (HKA) varied between 172° and 184° with an average of 179° for Site 1, 177° to 183° with an average of 179° for Site 2, and 177° to 185° with an average of 180° for Site 3. Pre-operative HKA ranged from 162 to 189°. Site 1 was already reporting in the series presented at ISTA 20132. Sites 2 and 3 were added later and could therefore benefit from the early feedback the analysis of site 1 cases provided. The use of the computer guidance at the new sites was associated with promising results and it did not take long to the surgeons to reach a reproducibility equivalent to the one of site 1. Average surgical time was similar in all three sites. GPS guidance added an average of 10 minutes to standard surgical times. All surgeons agreed the increased accuracy justified the additional time. Average post-operative HKA was 179°. HKA scores were within 3° of perfect alignment in 96% of the cases of Site 1, 99% of Site 2 and 97% of Site 3. According to the literature1, HKA between 177° and 183° is linked with high implant survival. Participating surgeons still associated Exactech GPS with satisfactory immediate post-operative results.
Early developments of computer assisted TKA focused on improving the technical aspects of proper registration, improved ease of use of instrumentation to ensure proper placement of cutting blocks and implants, and to document the technical improvements in alignment that come with the use of these technologies. There was minimal adoption of these technologies, as costs have been high and measured improvement in outcomes has not been demonstrated. Patient specific instrumentation (PSI), involving preoperative three dimensional imaging and engineering of patient specific guides have been more actively embraced by the orthopaedic community – with industry embracing the technology and promoting it vigorously. This has increased interest in the use of three dimensional technologies – with reported use by up to 14% of orthopaedists in the US- despite the fact that scientific evidence has been mixed. The next generation is merging these technologies, taking the best features of both to give the surgeon control of the patient specific TKA process. Sophisticated morphing technology coupled with innovative instrumentation now allows MONITORED real time PSI – affording the surgeon a means to fully understand the knee deformity being addressed, make decisions based on quantitative information that is accurate and easy to assess, and to resect and position parts as planned, confirming position easily (See Figure 1 & Figure 2). Additional ability to perform and monitor balancing is available if desired. From April 2012 to April 2013 sixty-two TKAs in 56 patients underwent TKA using the Exactech GPS system. Twenty-four knees had CR TKA for varus deformity, 5 for valgus deformity; 27 had PS TKA for varus deformity, 5 for valgus deformity. The average AP alignment was 4.0°; the average clinical ROM at the most recent follow-up for CR TKA was 107° vs. 112° for PS TKA which was not significantly different. One knee has been revised to a more constrained insert for CR deficiency. These cases were to validate the integrity of the instruments and software of a new navigation system. In April 2013, personalized instrumentation has been introduced to easily position femoral resection pins through a single, navigated instrument. Pin accuracy and cutting efficiency are easily documented, and proper femoral position in all planes is controlled. No additional imaging is needed, and the surgeon controls all aspects of decision making directly, monitored real-time patient specific TKA. It can easily be integrated for a balanced gap approach to implant positioning. This represents the newest application of three dimensional technologies and continues the field moving toward technologies that allow the surgeon to directly control all aspects of patient specific TKA.
The senior surgeon has performed THA in his practice for over 30 years, and, while performing THA and revision THA utilizing a variety of surgical approaches, has employed and taught the modified Gibson posterolateral approach to the hip joint as his “workhorse” surgical approach for the majority of his career. In following the development of the DAA, he felt that there were subgroups of patients in his practice for whom the DAA, and supine THA, might prove beneficial, and started to introduce this approach into his practice 2 years ago. This retrospective review describes the risks and benefits of choosing to introduce this approach, and outlines a rational way in which surgeons can decide if they should learn and then offer this approach to appropriate patients within their practice. A retrospective study was performed comparing outcomes of patients who underwent THA with the standard posterolateral approach vs. those who underwent THA with the direct anterior approach. Demographics such as age, gender, BMI and medical history were obtained. In addition, operative information and pre- and post-operative Harris Hip Score (HHS) evaluations were collected. Radiographic information and details about complications were also acquired.INTRODUCTION:
METHODS AND MATERIALS:
Clinical outcomes for total knee arthroplasty (TKA) are especially sensitive to lower extremity alignment and implant positioning.1 The use of computer-assisted orthopedic surgery (CAOS) can improve overall TKA accuracy.2 This study assessed the accuracy of an image-free CAOS guidance system (Exactech GPS, Blue-Ortho, Grenoble, FR) used in TKA. A high-resolution 3D scanner (Comet L3D, Steinbichler, Plymouth, MI) was used to scan seven knee models (MITA, Medical Models, Bristol, UK) and collect pre-identified anatomical landmarks (see Figure 1) prior to using the models to simulate knee surgery. The image-free CAOS guidance system was then used to acquire the same landmarks. After adjusting the position and orientation of the cutting block to match the targets, bone resections were performed, and the knee models were re-scanned. The 3D scans made before and after the cuts were overlaid (see Figure 2) and the resection parameters calculated using the pre-identified anatomical landmark data and advanced software (XOV & XOR, RapidForm, Lakewood, CO and UG NX, Siemens PLM, Plano, TX). Data sets obtained from the 3D scanner were compared with data sets from the guidance system. Given the accuracy of the 3D scanner, its measurements were used as the baseline for assessing CAOS system error.Introduction
Materials and methods:
From pre-operative planning to final implant cementation, total knee arthroplasty (TKA) can be defined by a succession of individual steps, each presenting potential errors that can result in devices being implanted outside the desired range of alignment. Our study used an image-free computer-assisted orthopedic surgery (CAOS) guidance system (Exactech GPS, Blue-Ortho, Grenoble, FR) to evaluate alignment discrepancies occurring during different steps of a typical TKA procedure. A surgical profile was established to define resection parameters and steps for proximal tibial and distal femoral cuts (see Figure 1A) to be made on seven synthetic knee models (MITA, Medical Models, Bristol, UK). First, the guidance system was used to acquire pre-identified landmarks. Next, a cutting block was adjusted to match the resection targets and then fixed to the bone using locking pins. Bone cuts were performed and then checked. Data was collected from the guidance system at three steps: (1) cutting block adjusted but not pinned to bone (see Figure 1B), (2) cutting block adjusted and pinned to bone (see Figure 1C), and (3) after checking cuts (see Figure 1D). These data were then compared to the resection target parameters to assess potential discrepancies.Introduction
Materials and methods:
Clinical outcomes for total knee arthroplasty (TKA) are especially sensitive to lower extremity alignment and implant positioning. The use of computer-assisted orthopedic surgery (CAOS) can improve overall TKA accuracy. This study assessed the accuracy of an image-free CAOS guidance system (Exactech GPS, Blue-Ortho, Grenoble, FR) used in TKA. A high-precision 3D scanner (Comet L3D, Steinbichler, Plymouth, MI) was used to scan seven knee models (MITA, Medical Models, Bristol, UK) and collect pre-identified anatomical landmarks prior to using the models to simulate knee surgery. The Exactech GPS was then used to acquire the same landmarks. After adjusting the Exactech GPS cutting block to match the targets, bone resections were performed, and the knee models were re-scanned. The 3D scans made before and after the cuts were overlaid and the resection parameters calculated using the pre-identified anatomical landmark data and advanced software (XOV & XOR, RapidForm, Lakewood, CO and UG NX, Siemens PLM, Plano, TX). Data sets obtained from the 3D scanner were compared with data sets from the guidance system. Given the accuracy of the 3D scanner, its measurements were used as the baseline for assessing CAOS system error. The CAOS system bone resection measurement errors had an overall mean of less than 0.35 mm. The mean errors for joint angle measurement was less than 0.6°. Even considering the ranges, errors were no more than 1 mm for all bone resection measurements and no more than 1° for all joint angle measurements. The low variability is also supported by small SD values. To our knowledge, this is the first study to use a high-resolution 3D scanner to assess the accuracy of surgical cuts made with image-free CAOS system assistance. Determining precise landmarks using CAOS for TKA has been shown to be of critical importance. For this reason, the anatomical landmarks used by the scanner and guidance system were carefully identified and prepared to ensure consistency. The study demonstrated that the evaluated image-free CAOS system was able to achieve a high level of
Sequentially annealed highly crosslinked polyethylenes (HXLPEs) were introduced in total knee replacement (TKR) starting in 2005 to reduce wear and particle-induced osteolysis. Few studies have reported on the clinical performance of HXLPE knees. In this study, we hypothesized that due to the reduced free radicals, sequentially annealed HXLPE would have lower oxidation levels than gamma inert-sterilized controls. 145 tibial components were retrieved at consecutive revision surgeries at 7 different surgical centers. 74 components were identified as sequentially annealed HXLPE (X3, Stryker) while the remainder (n = 71) were conventional gamma inert sterilized polyethylene. The sterilization method was confirmed by tracing the lot numbers by the manufacturer. The conventional inserts were implanted for 1.7 years (Range: 0.0–9.3 years), while the X3 components were implanted 1.1 years (Range: 0.0–4.5 years). Surface damage was assessed using the Hood method. Oxidation analysis was performed in accordance with ASTM 2102 following submersion in boiling heptane for 6 hours to remove absorbed lipids. 30 of the conventional and 29 of the HXLPE inserts were available for oxidation analysis.Introduction
Methods
The purpose of this multicenter study was to assess the oxidative stability, mechanical behavior, wear and reasons for revision of 2nd generation sequentially annealed HXLPE, X3, and compare it to 1st generation XLPE, Crossfire. We hypothesized that X3 would exhibit similar wear rates but lower oxidation than Crossfire. 182 hip liners were consecutively retrieved during revision surgeries at 7 surgical centers and continuously analyzed over the past 12 years in a prospective, multicenter study. 90 were highly crosslinked and annealed (Crossfire; Implanted 4.2±3.4 years, max: 11 years), and 92 were highly crosslinked and annealed in 3 sequential steps (X3; Implanted 1.2±1.5 years; max: 5 years). Oxidation was characterized in accordance with ASTM 2102 using transmission FTIR performed on thin sections (∼200μm) from the superior/inferior axis. Mechanical behavior was assessed via the small punch test (ASTM 2183).Introduction
Methods
A tibial insert with choices in size, thickness, and posterior slope is proposed to improve ligament balancing in total knee arthroplasty. However, increasing posterior slope, or the angle between the distal and proximal insert surfaces, will redistribute ultra-high molecular weight polyethylene (UHMWPE) thickness in the sagittal plane, potentially affecting wear. This study used in-vitro testing to compare wear for a standard cruciate-retaining tibial insert (STD) and a corresponding 6° sloped insert (SLP), both manufactured from direct-compression molded (DCM) UHMWPE. Our hypothesis was slope variation would have no significant effect on wear. Two of each insert (STD and SLP) were tested on an Instron-Stanmore knee simulator with a force-control regime. The gait cycle and other settings followed ISO 14243-1 and -2, except for reference positions. The STD insert was tilted 6° more than the SLP insert to level the articular surfaces. Wear was gravimetrically measured at intervals according to strict protocol.Introduction
Methods
While clinically successful for decades, CR TKA is persistently compromised by inconsistent PCL function. Problems of mid-flexion instability, incomplete knee flexion, erratic kinematic behavior and posterior instability, not seen with PS devices, raise concerns about the consistency of the technique, and the devices used. Most TKA systems offer at least 2 different geometries of tibial inserts to address this clinical problem. We hypothesize these problems are a result of compromise of PCL anatomy. To avoid compromise to the PCL 3 steps are required: 1) The slope of tibial resection must be less than 5°; 2) the depth of tibial resection must be based off the insertion footprint of the PCL, not the deficiencies of the tibial articular surface; and 3) the tibial insert must be modified to allow intraoperative balancing of the PCL. The CR Slope ™ implants and technique (Exactech) (“Posterior Cruciate Referencing Technique (PCRT)”) reflect this philosophy and have allowed consistent surgical intervention without PCL release and without multiple inserts. We present data identifying, the footprint, and the instrument and technique modifications that allow for predictable identification of the depth and angle of resection. At 2 years post implantation in the first 100 patients implanted, the study group has demonstrated similar operative time, LOS and Oxford knee scores (OKS), while ROM averaged 5° greater, and time to achieved flexion was decreased.Introduction
Results
A tibial insert with choices in posterior slope, size, and thickness is proposed to improve ligament balancing in total knee arthroplasty. However, increasing slope, or the angle between the distal and proximal insert surfaces, will redistribute ultra-high molecular weight poly-ethylene (UHMWPE) thickness in the sagittal plane, potentially affecting wear. This study used in-vitro testing to compare UHMWPE wear for a standard cruciate-retaining (CR) tibial insert (STD) and a corresponding 6° sloped insert (SLP). Our hypothe sis was that slope variation would have little effect on wear. Two of each style inserts were tested on an Instron-Stanmore knee simulator with a force-control regime. The gait cycle and other settings followed ISO 14243-1 &
2, except for the reference position, which was posteriorly shifted 6 mm to simulate the worst-case scenario. The STD insert was tilted 6° more than the SLP to level the articular surfaces. Wear was gravimetrically measured at intervals according to strict protocol. No statistical difference (p=0.36) was found between wear for the STD (9.5 ±1.8 mg/Mc) and SLP (11.4 ±0.5 mg/Mc) inserts. The overall wear rate measured was higher than previously published rates using implants similar to the STD inserts. This may relate to the shift in the reference position and the 6° slope, leading to increased shear loads. This is the first time the effect of tibial insert slope on wear has been evaluated in-vitro. When limited to 6°, wear testing suggests that al tering the tibial insert slope will have a minor effect on UHMWPE wear.
Total hip arthroplasty (THA) and Total knee arthroplasty (TKA) are successful operations that predictably restore function and provide pain relief for up to 20 years. What happens if they fail in the elderly patient? The purpose of this review was to evaluate pain relief, function and quality of life (QOL) in octogenarian patients undergoing revision total joint arthroplasty (TJA). We reviewed our surgical database to find all patients who were 80 years or older at the time of revision surgery. From 1993 through 2008, there were 61 revision THAs (52 patients) and 33 revision TKAs (29 patients). This represented 3% and 8% respectively of all arthroplasties and revision arthroplasties done during the same period. Outcomes evaluated include Harris Hip Scores (HHS), Knee Society Scores (KSS), complications, and QOL. The average follow-up for revision THA patients with completed Harris Hip Evaluations was 27 months (range: 3 – 126 months). HHS improved from 47 pre-operatively to 74 at most recent follow-up. Pain Scores improved from 20 to 39, Function Scores from 11 to 16, Activities Scores from 9 to 10, Deformity Scores from 2 to 4 and ROM Scores from 5 to 6. Complications occurred in 34% of these cases. The average follow-up for revision TKA patients with completed Knee Society Evaluations was 38 months (range: 11 – 98 months). KSS improved from 48 preoperatively to 84 at the most recent follow-up. Pain Scores improved from 22 to 43 and Function Scores from 20 to 34. Complications occurred in 47% of these cases. Total HHS and KSS greatly improved postoperatively with the most notable improvement in the Pain category. Complications were common, although most were considered minor. More severe complications occurred when revisions of all components were needed, more likely in TKA than THA. With careful selection, patient education and preoperative planning, revision TJA can be done safely and provide benefit for the elderly patient.
One of these total hip arthroplasties has been revised for incomplete femoral fixation leading to a 96% survival rate at an average follow-up of 22 months (range: 2 – 74 months). The average Harris Hip Score for these patients at the most recent follow-up was 87.
