As previous meta-analyses on the alignment outcomes of Computer-assisted orthopaedic surgery (CAOS) did not differentiate between CAOS systems, limited information is available on the accuracy of a specific CAOS system based on clinical cases. This study assessed the accuracy and precision of achieving surgical goals in approximately 7000 cases using a specific contemporary CAOS system. Alignment parameters were extracted from the technical logs of 6888 TKA surgeries performed between October 2012 and January 2017 using a contemporary CAOS system. The following surgical parameters were investigated: 1) planned resection defined by the surgeon prior to the bone cuts; 2) Checked resection defined as digitalisation of the bony cuts. Deviations in alignment between planned and checked resections were evaluated, with acceptable resections defined as no more than 3° of resection deviations. For the tibial resection, deviations in tibial varus/valgus angle and posterior tibial slope were 0.06 ± 0.94° and −0.09 ± 1.73°, respectively. For the femoral resection, deviations in femoral varus/valgus angle amd femoral flexion were 0.00 ± 0.97° and −0.17 ± 1.44°, respectively. High percentages of the resections were found to be acceptable (>94% of the cases). The CAOS system investigated was shown to provide accurate and precise intra-operative assistance to the surgeon in achieving targeted resections. The study summarised a large number of cases spanning the application history of the specific CAOS system, including both experienced users and new adopters of the technology. The data provided a complete clinical relevant evaluation demonstrating its high accuracy and precision in resection alignment.
Computer-assisted orthopaedic surgery (CAOS) has been demonstrated to increase accuracy to component alignment of total knee arthroplasty compared to conventional techniques. The purpose of this study was to assess if learning affects resection alignment using a specific CAOS system. Nine surgeons, each with >80 TKA experience using a contemporary CAOS system were selected. Prior to the study, six surgeons had already experienced with CAOS TKA (experienced), while the rest three were new to the technology (novice). The following surgical parameters were investigated: 1) planned resection, resection parameters defined by the surgeon prior to the bone cuts; 2) checked resection, digitalisation of the realised resection surfaces. Deviations in the alignment between planned and checked resections were compared between the first 20 cases (in learning curve) and the last 20 cases (well past learning curve) within each surgeon. Any significance detected (p < 0.05) with >1° difference in means indicated clinically meaningful impact on alignment by the learning phase. Both pooled and surgeon-specific analysis exhibited no clinically meaningful significant difference between the first 20 and the last 20 cases from both experienced and novice surgeon groups. The resections in both the first 20 and the last 20 cases demonstrated acceptable rates of over 95% in alignment (<3° deviation) for both experienced and novice surgeons. This study demonstrated that independent of the surgeon's prior CAOS experiences, the CAOS system investigated can provide an accurate and precise solution to assist in achieving surgical resection goals with no clinically meaningful compromise in alignment accuracy and outliers during the learning phase.
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
One main perceived drawback for the adoption of computer assisted orthopedic surgery (CAOS) during total knee arthroplasty (TKA) relates to the increased surgical time compared to the use of standard mechanical instrumentation [1]. This study compared the time efficiency between a next generation CAOS system (ExactechGPS®, Blue-Ortho, Grenoble, FR) and conventional mechanical instrumentation, and assessed the impact of surgeon experience level on the efficiency. Surgical time was retrospectively reviewed on 63 primary TKAs performed by a board-certified orthopedic surgeon (PP) using a cemented postero-stabilized knee system (Optetrak Logic PS, Exactech, Gainesville, FL), grouped as 1) Group I (control): 21 TKAs using conventional mechanical instruments; 2) Group II: 21 TKAs performed using the CAOS system with an early experience level (first 21 cases); and 3) Group III: 21 TKAs using the CAOS system with an advanced experience level (beyond 30 cases). Surgical time was compared across the three groups (with significance defined as p<0.05).Introduction
Materials and methods
Total knee arthroplasty (TKA) can effectively treat end-stage knee osteoarthritis. For cruciate-retaining (CR) TKA, the posterior tibial slope (PTS) of the reconstructed proximal tibia plays a significant role in restoring normal knee kinematics as it directly affects the tension of the posterior cruciate ligament (PCL) [1]. However, conventional cadaveric testing of the impact of PTS on knee kinematics may damage/stretch the PCL, therefore impact the test reproducibility. The purpose of this study was to assess the reproducibility of a novel method for the evaluation of the effects of PTS on knee kinematics. Cemented CR TKAs (Logic CR, Exactech, Gainesville, FL, USA) were performed using a computer-assisted surgical guidance system (ExactechGPS®, Blue-Ortho, Grenoble, FR) on six fresh frozen non-arthritic knees (PCL presumably intact). The tibial baseplate was specially designed (Fig. 1) with a mechanism to modify the PTS in-situ. Knee kinematics, including anteroposterior (AP) translation, internal/external (IE) rotation, and hip-knee-ankle angles, were evaluated by performing a passive range of motion from extension up to ∼110° of flexion, three separate times at 5 PTSs: 10°, 7°, 4°, 1°, and then 10° again. The repeatability of the test was investigated by comparing the kinematics between the first and the last 10° tests. Any clinically relevant deviation (1.5° for the hip knee ankle angle, 1.5mm for anterior-posterior translation and 3° for internal-external rotation) would reflect damage to the soft-tissue envelope or the PCL during the evaluation. Potential damage of PCL was investigated by comparing the kinematic parameters from the first and last 10° slope tests at selected flexion angles (Table 1) by paired t-test, with statistical significance defined as p<0.05.Introduction
Materials and Methods
Computer-assisted orthopaedic surgery (CAOS) has been shown to assist in achieving accurate and reproducible prosthesis position and alignment during total knee arthroplasty (TKA) [1]. The most prevalent modality of navigator tracking is optical tacking, which relies on clear line-of-sight (visibility) between the localizer and the instrumented trackers attached to the patient. During surgery, the trackers may not always be optimally positioned and orientated, sometimes forcing the surgeon to move the patient's leg or adjust the camera in order to maintain tracker visibility. Limited information is known about tracker visibility under clinical settings. This study quantified the rotational limits of the trackers in a contemporary CAOS system for maintaining visibility across the surgical field. A CAOS system (ExactechGPS®, Blue-Ortho, Grenoble, FR) was set up in an operating room by a standard surgical table according to the manufacture's recommendation. A grid with 10×10 cm sized cells was placed at the quadrant of the surgical table associated with the TKA surgical field [Fig. 1A,B]. The localizer was set up to aim at the center of the grid. A TKA surgical procedure was then initiated using the CAOS system. Once the trackers-localizer connection was established, the CAOS system constantly monitored the root mean square error (RMS) of each tracker. The connection was immediately aborted if the measured RMS was above the defined threshold. Therefore, “visibility” was defined as the tracker-localizer connection with proper accuracy level. An F tracker from the tracker set (3 trackers with similar characteristics) was placed at the center of each cell by a custom fixture, facing along the +Y axis [Fig. 1]. The minimum and maximum angles of rotation around the Z axis (RAZ_MIN and RAZ_MAX) and X axis (RAX_MIN and RAX_MAX) for maintaining tracker visibility were identified. For each cell, the rotational limit of the tracker was calculated for each axis of rotation as the difference between the maximum and minimum angles (RLX and RLZ).Introduction
Materials and Methods
While total knee arthroplasty (TKA) improves postoperative function and relieves pain in the majority of patients with end stage osteoarthritis, its ability to restore normal knee kinematics is debated. Cadaveric studies using computer-assisted orthopaedic surgery (CAOS) system [1] are one of the most commonly used methods in the assessment of post-TKA knee kinematics. Commonly, these studies are performed with an open arthrotomy; which may impact the knee kinematics. The purpose of this cadaveric study was to compare the knee kinematics before and after (open or closed) arthrotomy. Kinematics of seven non-arthritic, fresh-frozen cadaveric knees (PCL presumably intact) was evaluated using a custom software application in an image-free CAOS system (ExactechGPS, Blue-Ortho, Grenoble, FR). Prior to the surgical incision, one tracker was attached to the diaphysis of each tibia and femur. Native intact knee kinematics was then assessed by performing passive range of motion (ROM) three separate times, from full extension to at least 110 degrees of flexion, with the CAOS system measuring and recording anatomical values, including flexion angle, internal-external (IE) rotation and anterior-posterior (AP) translation of the tibia relatively to the femur, and the hip-knee-ankle (HKA) angle. Next, an anterior incision with a medial parapatellar arthrotomy was performed, followed by acquisition of the anatomical landmarks used for establishing an anatomical coordinate system in which all the anatomical values were evaluated [2]. The passive ROM test was then repeated with closed and then open arthrotomy (patella manually maintained in the trochlea groove). The anatomical values before and after knee arthrotomy were compared over the range of knee flexion using the native knee values as the baseline.Introduction
Materials and Methods
Computer-assisted orthopaedic surgery (CAOS) has been shown to help achieve accurate, reliable and reproducible prosthesis position and alignment during total knee arthroplasty (TKA) [1]. A typical procedure involves inputting target resection parameters at the beginning of the surgery and measuring the achieved resection after bone cuts. Across CAOS systems, software/hardware design, mechanical instrumentation, and system-dependent work flow may vary, potentially affecting the intraoperative measurement of the achieved resection. This study assessed the cumulative effect of system-dependent differences between two CAOS systems by comparing the alignment deviation between the measurement of the achieved resection and the targeted parameters. TKA resections were performed on 10 neutral whole leg assemblies (MITA knee insert and trainer leg, Medial Models, Bristol, UK) by a board-certified orthopaedic surgeon (BH) using System I (5 legs, ExactechGPS®, Blue-Ortho, Grenoble, FR) and System II (5 legs, globally established manufacturer). The surgeon was deemed as “experienced” user (>30 surgeries) with both systems. The target parameters for the TKA resections, as well as major differences between the two systems are summarized in Table 1A. The deviations of the intraoperative alignment measurements on the achieved distal femoral and proximal tibial resection from the target were calculated and compared between the two systems with significance defined as p<0.05.Introduction
Materials and Methods
Cemented total knee arthroplasty (TKA) is a widely accepted treatment for end-stage knee osteoarthritis. During this procedure, the surgeon targets proper alignment of the leg and balanced flexion/extension gaps. However, the cement layer may impact the placement of the component, leading to changes in the mechanical alignment and gap size. The goal of the study was to assess the impact of cement layer on the tibial mechanical alignment and joint gap during cemented TKA. Computer-assisted TKAs (ExactechGPS®, Blue-Ortho, Grenoble, FR) were performed by two fellowship trained orthorpaedic surgeons on five fresh-frozen non-arthritic pelvis-to-ankle cadaver legs. All the surgeries used a cemented cruciate retaining system (Optetrak Logic CR, Exactech, Gainesville, FL). After the bony resection, the proximal tibial resection plane was acquired by manually pressing an instrumented checker onto the resected tibial surface (resection plane). Once the prosthesis was implanted through standard cementing techniques, the top surface of the implanted tibial component was probed and recorded using an instrumented probe. A best fit plane was then calculated from the probed points and offset by the thickness of the prosthesis, representing the bottom plane of the component (component plane). The deviation of component alignment caused by the cement layer was calculated as the coronal and sagittal projection of the three-dimensional angle between the resection plane and the component plane. The deviation of the component height, reflecting a change in the joint gap, was assessed as the distance between the two planes calculated at the lowest points on the medial and lateral compartments of the proximal tibial surface. Statistical significance was defined as p≤0.05.INTRODUCTION
MATERIAL
Total knee arthroplasty (TKA) is an effective technique to treat end-stage osteoarthritis of the knee. One important goal of the procedure is to restore physiological knee kinematics. However, fluoroscopy studies have consistently shown abnormal knee kinematics after TKA, which may lead to suboptimal clinical outcomes. Posterior slope of the tibial component may significantly impact the knee kinematics after TKA. There is currently no consensus about the most appropriate slope. The goal of the present study was to analyze the impact of different prosthetic slopes on the kinematics of a PCL-preserving TKA. The tested hypothesis was that the knee kinematics will be different for all tested tibial slopes. PCL-retaining TKAs (Optetrak Logic CR, Exactech, Gainesville, FL) were performed by fellowship trained orthopedic surgeons on six fresh frozen cadaver with healthy knees and intact PCL. The TKA was implanted using a computer-assisted surgical navigation system (ExactechGPS®, Blue-Ortho, Grenoble, FR). The implanted tibial baseplate was specially designed (figure 1) to allow modifying the posterior slope without repeatedly removing/assembling the tibial insert with varying posterior slopes, avoiding potential damages to the soft-tissue envelope.INTRODUCTION
MATERIAL
Although total knee arthroplasty (TKA) is a largely successful procedure to treat end-stage knee osteoarthritis (OA), some studies have shown postoperative abnormal knee kinematics. Computer assisted orthopaedic surgery (CAOS) technology has been used to understand preoperative knee kinematics with an open joint (arthrotomy). However, limited information is available on the impact of arthrotomy on the knee kinematics. This study compared knee kinematics before and after arthrotomy to the native knee using a CAOS system. Kinematics of a healthy knee from a fresh frozen cadaver with presumably intact PCL were evaluated using a custom software application in an image-free CAOS system (ExactechGPS, Blue-Ortho, Grenoble, FR). At the beginning of the test, four metal hooks were inserted into the knee away from the joint line (one on each side of the proximal tibia and the distal femur) for the application of 50N compressive load to simulate natural knee joint. Prior to incision, one tracker was attached to each tibia and femur on the diaphysis. Intact knee kinematics were recorded using the CAOS system by performing passive range of motion 3 times. Next, a computer-assisted TKA procedure was initiated with acquisition of the anatomical landmarks. The system calculated the previously recorded kinematics within the coordinate system defined by the landmarks. The test was then repeated with closed arthrotomy, and again with open arthrotomy with patella maintained in the trochlea groove. The average femorotibial AP displacement and rotation, and HKA angle before and after knee arthrotomy were compared over the range of knee flexion. Statistical analysis (ANOVA) was performed on the data at ∼0° (5°), 30°, 60°, 90° and 120° flexion. The intact knee kinematics were found to be similar to the kinematics with closed and open arthrotomy. Differences between the three situations were found, in average, as less than 0.25° (±0.2) in HKA, 0.7mm (±0.4) in femorotibial AP displacement and 2.3° (±1.4) in femorotibial rotation. Although some statistically significant differences were found, especially in the rotation of the tibia for low and high knee flexion angles, the majority is less than 1°/mm, and therefore clinically irrelevant. This study suggested that open and closed arthrotomy do not significantly alter the kinematics compared to the native intact knee (low RMS). Maintaining the patella in the trochlea groove with an open arthrotomy allows accurate assessment of the intact knee kinematics.
Total knee arthroplasty (TKA) is an effective technique to treat end-stage knee osteoarthritis, targeting the restore a physiological knee kinematics. However, studies have shown abnormal knee kinematics after TKA which may lead to suboptimal clinical outcomes. Posterior slope of the tibial component may significantly impact the knee kinematics. There is currently no consensus about the most appropriate slope. The goal of the present study was to analyse the impact of different prosthetic slopes on the kinematics of a PCL-preserving TKA, with the hypothesis that posterior slopes can alter the knee kinematics. A PCL-retaining TKA (Optetrak CR, Exactech, Gainesville, FL) was performed by a board-certified orthopaedic surgeon on one fresh frozen cadaver that had a non arthritic knee with an intact PCL. Intact knee kinematic was assessed using a computer-assisted orthopaedic surgery (CAOS) system (ExactechGPS®, Blue-Ortho, Grenoble, FR) Then, TKA components were implanted using the guidance of the CAOS system. The implanted tibial baseplate was specially designed to allow modifying the posterior slope without repeatedly removing/assembling the tibial insert with varying posterior slopes, avoiding potential damages to the soft-tissue envelope. Knee kinematic was evaluated by performing a passive range of motion 3 separate times at each of the 4 posterior slopes: 10°, 7°, 4° and 1°, and recorded by the navigation system. Femorotibial rotation, antero-posterior (AP) translation and hip-knee-ankle (HKA) angle were plotted with regard to the knee flexion angle. Tibial slopes of 1° and 4° significantly altered the normal rotational kinematics. Tibial slopes of 7° and 10° led to a kinematics close to the original native knee. All tibial slopes significantly altered the changes in HKA before 90° of knee flexion, without significant difference between the different slopes tested. The magnitude of change was small. There was no significant change in the AP kinematics between native knee and all tested tibial slopes. Changing the tibial slope significantly impacted the TKA kinematics. However, in the implant studied, only the rotational kinematics were significantly impacted by the change in tibial slope. Tibial slopes of 7° and 10° led rotational kinematics that were closest to that of a normal knee. Alterations in knee kinematics related to changing tibial slope may be related to a change in the PCL strain. However, these results must be confirmed by other tests involving more specimens.
Clinical outcomes for total knee arthroplasty (TKA) are sensitive to lower extremity alignment, implant positioning, and implant size. Accurate determination of femoral implant size is the focus of this paper. As existing methods (conventional instrumentation, preoperative images, navigation) can be limited by issues including inaccuracy, time required, exposure, and cost, this study assesses a novel method for determining femoral component size using navigation. We used a commercially available navigation system (Exactech GPS, Blue Ortho, Grenoble, FR, with Total Knee V1.13 software). The system uses surface patches to collect small point clouds, and then computes points that match a given criteria (e.g. the most distal point). For femoral component sizing, the proposed method automatically defines a target area to be digitised on the anterior cortex. To do this, the surgeon acquires anatomical landmarks (i.e., knee centre, distal condyles, etc.) for all femoral implant parameters but the size. The surgeon then moves the tip of the acquisition instrument near the anterior cortex, and the system computes the distance between the virtual posterior cut and the tip in real time. The theoretical implant size increases in real time as the instrument tip moves anteriorly and decreases as it moves posteriorly. The target area is displayed on the anterior cortex such that it covers all the bone in the medio-lateral direction, is centred on the most proximal part of the theoretical implant in the proximal-distal direction, and covers the current size plus or minus one size. As a result, the target area virtually moves in the proximal-distal direction as the surgeon moves the instrument tip closer to the anterior cortex surface. When the tip is in contact with the anterior surface, acquisition of the point cloud is performed. From a user point of view, the system does not move the target area relative to the bone on the display, but instead adjusts the relative position of the instrument tip, creating the impression that no matter the bone size, the target area does not move and the instrument tip is always guided to the right spot. The method has been successfully implemented and used on more than 1,400 patients. A preliminary analysis on 189 surgical reports shows in 188 cases (99,5%) the proximal point of the selected implant is inside the target area (which means that the selected size is the one by default, plus or minus one). We conclude the proposed method as implemented in the Exactech GPS has proven to be clinically effective. It can easily be extended to determination of other points when global criteria can be used to define an optimal area of digitisation determined from previously acquired data.
