Purpose. Many TKA instruments were developed in these days. Distal femoral cutting guide using intra-medullary system were divided into two methods, from anterior or medial. Many companies employed anterior cutting guide, however these guides have a disadvantage of wide skin and quadriceps incision. Only Zimmer provided medial cut guide which performed short skin and quadriceps incision. However, reference point (medial femoral condyle) will be a risk of imprecise cutting for a medial condyle defect cases. We tried L-shaped new distal femoral cutting guide, reference point will be both femoral condyle and cutting from antero-medial side. The purpose of this study was to prove usefulness of the new guide. Materials and Methods. Twenty-nine knees were employed in this study. All knees were treated with Optetrak knee system (Exactec). Surgical methods were as follows, mid line skin incision, short para-patellar deep incision, no patellar resurfacing, PS type implant and cement fixation were employed. 13 knees were used original anterior cutting guide (O group) and 16 knees were used new antero-medial cut guide (N group). Study items were length of skin incision, length of Quadriceps incision, surgical time, JOA score, and component tilting angles (implant position were compared to femoral axis with AP and lateral view of roentgenograms). Results. Average skin incision was 11.7cm in O group and 10.6cm in N group. Average Quadriceps incision was 4.1cm in O group and 2.9cm in N group. There were significant difference in length of skin incision and length of Quadriceps incision. Average surgical time was 155min in O group and 147min in N group. Average component angles of AP view were 84 deg. in O group and 83 deg. in N group. Average component angles of lateral view were 99 deg. in O group and 99 deg. in N group. There were no significant differences between O group and N group in surgical time, component angles, amount of bleeding, and post surgical JOA scores. Conclusions. New distal femoral cutting guide demonstrated same precise cutting compared to original guide. New distal femoral cutting guide achieved small skin incision and small quadriceps incision which is useful for MIS-TKA

Introduction. Robotic-guided arthroplasty procedures are becoming increasingly common, though to our knowledge there are no published studies on robotic cutting guides in TKA. We introduced a new computer-navigated TKA system with a robotic cutting-guide into a community-based hospital and characterized the accuracy and efficiency of the technique with respect to bone cutting, component alignment and final limb alignment, and tourniquet time. Methods. The first 100 cases from a single-surgeon were retrospectively reviewed following IRB approval. Intra-operative bone-cut accuracy and overall limb alignment as measured by the computer were collected and divided into consecutive quartiles: Group I, cases 1–25; Group II, cases 26–50; Group III, cases 51–74; Group IV, cases 75–100. All resections were planned neutral to the mechanical axis. Postoperative component alignment and the overall mechanical axis limb alignment in the coronal plane were also measured on standing long-leg AP radiographs by two independent observers at a minimum six weeks post-op. This mechanical radiographic alignment was available for 62 cases. Tourniquet time (the time prior to incision until after cementation) and robotic cutting guide use time were also analyzed. Results. Intra-operative Computer Data: Bone-cut accuracy was a mean 0.1° valgus, SD±0.8° for both the femur and tibia (range, femur: 2.0° valgus to 1.5° varus; range, tibia: 3.5° valgus to 1.5° varus). Final limb alignment was within 3° of neutral for 98% (96/98) of cases (range: 2.0° valgus to 3.5° varus). Radiographic Alignment Data: Pre-operative mechanical alignment ranged from −14.5° valgus to 21.5° varus. Radiographic femoral and tibial component alignment was within 3° of neutral in 98.4% of cases (61/62). Final limb alignment was within 3° of neutral for 87.1% (54/62) of cases (range: 4.5° varus to 4.5° valgus). Learning curve: Mean tourniquet time was 10 minutes longer for Group I (60 minutes ± 9.9SD, range 46–79) than for groups II, III, and IV (average mean 49.5min, range 35–68), p=0.0001. Within Group I, mean tourniquet time for the first ten and second ten procedures was 65 ± 10.6 min and 55 ± 8.3 min, respectively, p=0.034. Robotic-guide use time was also longer for the first quartile (7.8 ± 1.9 minutes, range 4–12), than for Groups II, III, and IV (average 5.2 minutes, range, 3–8), p<0.001. There were no significant differences in any of the accuracy measures among the different groups (p>0.05). Conclusion. Imageless computer-navigated TKA with a robotic cutting guide allowed one surgeon to make bone resections within 3° of neutral in 98% of cases. Radiographic limb alignment was less precise, which is consistent with the known limitations inherent to this measurement technique. During the learning curve phase, surgeons can expect the procedure to take an average of 15 extra minutes during the first ten cases and 5 extra minutes during the second ten without compromising accuracy

Background: A navigated 8 in 1 femoral cutting guide for TKA that does not require primary fixation or intramedullary guides was developed. The hypothesis of our study were twofold: 1) the navigation system allows for precise alignment and adjustment of a new femoral 8 in 1 cutting guide with negligible variance in the initially planned vs. achieved implant position; 2) resulting femoral cuts are very accurate without relevant cutting errors. Material and Methods: We demonstrate our approach with the Universal Knee Instrument (UKI, Precimed Inc. USA), a versatile 8 in 1 TKA guide designed to perform all femoral cuts with a single jig. We integrated an array of “adjustable constraints” into the UKI by machining four threaded holes directly through the template. Adaptation to a navigation system has been performed by integrating the adjustable constraints protocol on the open platform Surgetics Station (PRAXIM-medivision, France), which uses image-free BoneMorphing technology. Based on navigated bone morphing the required preadjustment of the guide was done mechanically, with depth control by mini screws. Testings on 10 cadavers compared the planned vs. achieved positions of the jig before, after fixation, final implant position and planned vs. achieved cutting procedures. Results: Results revealed for valgus/varus deviations before fixation −0.1°±0.7°, after 0.0°±0.8° (p=0.51), final implant position 0.9°±1.7° (p=0.93). For flexion before fixation −0.3°±1.3° after −0.3°±1.8° (p=0.44), final position 2.9°±2.5° (p=0.65). Distal cut height before fixation 0.0°±0.4°, after 0.1°±0.3° (p=0.61), final position 0.3°±1.0° (p=0.1). Axial rotation before −0.3°±1.1°, after fixation 0.2°±1.4° (p=0.57), final implant position 0.8°±2.7° (p=0.89). Anterior-posterior positions before fixation 0.7°±1.4°, after 1.0°±1.6° (p=0.27), final position 3.4°±1.3° (p=0.13). Highest deviations in the planned vs. actual cut position was found for the posterior cut −3.1°±2.4° in sagittal and anterior cut 0.8°±1.9° in the coronal plane. The highest mean errors in the final implant position where on the order of 3 degrees/mm in flexion and anterior-posterior positioning. Conclusion: A novel ‘CAS-enabled 8 in 1 jig’ has been developed and validated. The system allows for direct execution of a complex, multi-planar CAS plan with single navigated device. The instrumentation is considerably simplified and eliminates the problems associated with sequential jigs

Robotic-guided arthroplasty procedures are becoming increasingly common. We introduced a new computer-navigated TKA system with a robotic cutting-guide into a community-based hospital and characterized the accuracy and efficiency of the technique. We retrospectively reviewed our first 100 cases following IRB approval. Tourniquet time, intraoperative bone-cut accuracy and final limb alignment as measured by the computer were collected and divided into consecutive quartiles: Groups I, II, III, and IV; 25 cases per group. All resections were planned neutral to the mechanical axis. Postoperative component alignment and overall mechanical axis limb alignment were also measured on standing long-leg radiographs by two independent observers at minimum six weeks follow-up. Radiographic alignment was available for 62 cases. Intraoperative Computer Data: Bone-cut accuracy was a mean 0.1° valgus, SD±0.8° for both the femur and tibia (range, femur: 2.0° valgus to 1.5° varus; range, tibia: 3.5° valgus to 1.5° varus). Final limb alignment was within 3° for 98% (97/99) of cases (range: 2.0° valgus to 3.5° varus). Radiographic Alignment: Pre-operative mechanical alignment ranged from −14.5° valgus to 21.5° varus. Radiographic femoral and tibial component alignment was within 3° of neutral in 98.4% of cases (61/62). Final limb alignment was within 3° for 87.1% (54/62) of cases (range: 4.5° varus to 4.5° valgus). Learning curve: Mean tourniquet time was 60minutes ±9.9SD (range 46–79) for Group I and 49.5minutes for Groups II, III, and IV (range 35–68), p = 0.0001. Mean tourniquet time for the first ten and second ten procedures was 65±10.6minutes and 55±8.3minutes, respectively, p = 0.034. There were no differences in accuracy among the four groups (p>0.05). Imageless computer-navigated TKA with a robotic cutting guide allowed one surgeon to make bone resections within 3° of neutral in 98% of cases. Radiographic limb alignment was less precise, which is consistent with the known limitations inherent to this measurement technique. Surgeons can expect this procedure to take 15 additional minutes during the first ten cases and five additional minutes during the second ten cases on average, without compromising accuracy

Introduction. Proper alignment (tibial alignment, femoral alignment, and overall anatomic alignment) of the prosthesis during total knee replacement is critical in maximizing implant survival[7] and to reduce polyethylene wear[1]. Poor overall anatomic alignment of a total knee replacement was associated with a 6.9 times greater risk of failure due to tibial collapse, that varus tibial alignment is associated with a 3.2 times greater risk[2] and valgus femoral alignment is associated with a 5.1 times greater risk of failure[7]. To reduce this variability intramedullary (IM) instruments have been widely used, with increased risk of the fat emboli rate to the lungs and brain during TKA[6] and possible increase of blood loss[4, 5]. Or, alternatively, navigation has been used to achieve proper alignment and to reduce morbidity[3]. Recently, for distal femoral resection, inertial sensors have been coupled to extramedullary (EM) instruments to improve TKA surgery in terms of femoral implant alignment, with respect to femoral mechanical axis, and reduced morbidity by avoidance of IM canal violation. The purpose if this study is to compare blood loss and alignment of distal femoral cut in three cohorts of patients: 1 Operated with inertial based cutting guide; 2 Operated with navigation instruments; 3 operated with conventional IM instruments. Material and methods. From September to November 2014 30 consecutive patients, eligible for TKA, were randomly divided into three cohorts with 10 patients each:x 1 “EM Perseus”, patient operated with EM inertial based instruments (Perseus, Orthokey Italia srl, Florence, Italy); 2 “EM Nav”, operated with standard navigated technique, where bone resections were planned and verified by mean of navigation system (BLUIGS, Orthokey Italia srl, Florence, Italy); 3 “IM Conv”, operated with standard IM instrumentation. All patients were operated by the same surgical technique, implanted TKA were mobile bearing PS models, Gemini (Waldemar Link, Hamburg, Germany) and Attune (Depuy, Warsaw, Indiana). Anteroposterior, lateral, and full-limb weightbearing views preoperatively and postoperatively at discharge were obtained, taking care of neutral limb rotational positioning in all patients enrolled in the study. Angles between femoral mechanical axis and implant orientation on frontal and lateral planes were measured with a CAD software (Rhinoceros 3, McNeel Europe, Rome, Italy) by two independent persons, average value was used for statistical analysis. Haemoglobin values were recorded at three time intervals: the day before surgery, at 24h follow-up and at patients discharge. Statistical analysis. Kruskal-Wallis test was used to compare differences between the three cohorts in blood loss and femoral implant alignment. Results. All the three cohorts were comparable in terms of age, sex, preoperative limb alignment and preoperative haemoglobin values (Tab. 1). Haemoglobin ad discharge was reduced for all three cohorts (Tab. 2), no significant differences was found even if IM Conv group showed higher loss compared to EM Perseus and EM Nav groups. Femoral implant alignment deviation, considering perpendicularity with femoral mechanical axis as goal, was comparable in frontal and lateral plane for all three cohorts (Tab. 2). Discussion. The aim of the study was to compare the accuracy in femoral component positioning, on the coronal and sagittal plane obtained with a new inertial based EM instrument, with a standard IM distal femoral cutting jig and with navigation. We confirm our hypothesis that the use of inertial based EM instruments to perform the distal femoral bone cut in TKA is reliable and at least as accurate as the standard IM technique and navigation. Our study did not show a statistical decrease in blood loss when the femoral canal was not reamed (in inertial based EM, and navigated groups), even if patient operated with IM instruments had sensibly higher blood loss compared to the other two groups. This study was not exactly powered for that purpose, a study with a larger cohort and strict patient selection criteria would be required. This study demonstrates that inertial based EM instruments is accurate for femoral component alignment in TKA and compares favorably to navigation systems and standard IM techniques. Other indications for the use of inertial based EM instruments include all major femoral extraarticular deformities, the presence of ipsilateral long-stemmed hip arthroplasty, and the presence of hardware such as distal femoral plates and screws or IM nails

Introduction. In major orthopaedic departments, typically several total knee systems are used. Each system requires several sets of instruments, each set with many trays of complicated and expensive parts. The logistics and costs of maintainance are considerable. Our overall goal is to investigate the feasibility of autoclavable single-use 3D printed instruments made from a polymeric material, used for any type of total knee design. The procedure will be standardized and adjustments easy to implement. Each set will be packaged individually, and used for a single case. There are many aspects to this study; in this part, the aims are to identify suitable materials for autoclavability and strength, and then to compare the accuracy of a novel design of 3D printed tibial cutting guide with a current metallic guide. Methods. Test samples were designed to simulate shapes in current instruments, such as mating pegs and holes, threaded screws, and slotted blocks. Each set was produced in biocompatible materials, ABS-M30i, VeroClear (MED610), Ultem1010, and Nylon 12. Each part was laser scanned, and then imaged virtually using a reverse engineering software (GeoMagic). Manual measurements of key dimensions were also made using calipers. The parts were autoclaved using a standardized protocol, 30 minutes at 250° F. All parts were re-scanned and measured to determine any changes in dimensions. To test for strength and abrasion resistance, the slotted blocks were pinned to sawbones model tibias, and an oscillating saw used to cut through the slot. A compact 3D printed tibial cutting guide was then designed which fitted to the proximal tibia and allowed varus-valgus, tibial slope and height adjustments. A small laser attached to the guide projected to a target at the ankle. Tests were made on 20 sawbones, and compared with 20 with a standard metal cutting guide. Digitization was used to measure the angles of the cuts. Results. Prior to autoclaving, the mating parts of all parts were congruent, except for Nylon 12 which had processing debris in slots and screw threads. The ABS-M30i shapes became grossly deformed after autoclaving. The other materials experienced only small changes in dimensions without loss of overall shape, but the slot of the Nylon 12 block was stenotic, 1.4 mm compared to 0.9 mm before autoclaving. In saw blade testing, the VeroClear block fractured through the corner of the slot, while the Nylon 12 block deformed due to heating. The Ultem1010 block produced a small amount of debris, but maintained its shape without any structural damage. In the tests of the tibial cutting guide the 3D printed laser-guided tibial cutting guide resulted in a mean absolute error of 1.72°±1.31° and 1.19°±0.93°, for the tibial slope and varus-valgus respectively. For the conventional guides, these values were 3.78°±1.98° and 2.33°±0.98°, respectively. These measurements were found to be statistically significant with p values of 0.004 and 0.001, respectively. Conclusions. Thus far, apart from patient specific cutting guides and trial components, 3D printing has had limited applications in total knee surgery. As cost containment remains prominent, the use of 3D printing to produce standardized instruments may become viable. These instruments would not require pre-op planning such as CT or MRI, yet allow patient-specific angular settings. Our results indicated that Ultem1010 is a promising material, while a novel tibial cutting guide showed higher accuracy than standard, as well as being quicker to use. These initial tests indicated the viability of 3D printed instruments, but further work will include design and evaluation of the other cutting guides, manufacturing logistics such as in-house or company- based, and economics

In the last years, 3d printing has progressively grown and it has reached a solid role in clinical practice. The main applications brought by 3d printing in orthopedic surgery are: preoperative planning, custom-made surgical guides, custom-made im- plants, surgical simulation, and bioprinting. The replica of the patient's anatomy, starting from the elaboration of medical volumetric images (CT, MRI, etc.), allows a progressive extremization of treatment personalization that could be tailored for every single patient. In complex cases, the generation of a 3d model of the patient's anatomy allows the surgeons to better understand the case — they can almost “touch the anatomy” —, to perform a more ac- curate preoperative planning and, in some cases, to perform device positioning before going to the surgical room (i.e. joint arthroplasty). 3d printing is also commonly used to produce surgical cutting guides, these guides are positioned intraoperatively on given landmarks to guide the surgeon to perform a specific surgical act (bone osteotomy, bone resection, implant position, etc.). In total knee arthroplasty, custom-made cutting guides have been developed to help the surgeon align the femoral and tibial components to the pre-arthritic condition with- out the use of the intramedullary femoral guide. 3d printed custom-made implants represent an emerging alternative to biological reconstructions especially after oncologic resection surgery or in case of complex arthroplasty revision surgery. Custom-made implants are designed to re- place the original shape and size of the patient's bone and they allow an extreme personalization of the treatment for every single patient. Patient-specific surgical simulation is a new frontier that promises great benefits for surgical training. a solid 3d model of the patient's anatomy can faithfully reproduce the surgical complexity of the patient and it allows to generate surgical simulators with increasing difficulty to adapt the difficulties of the course with the level of the trainees performing structured training paths: from the “simple” case to the “complex” case

Recent innovations in total ankle replacement (TAR) have led to improvements in implant survivorship, accuracy of component positioning and sizing, and patient outcomes. CT-generated pre-operative plans and cutting guides show promising results in terms of placement enhancement and reproducibility in clinical studies. The purpose of this study was to determine the accuracy of 1) implant sizes used and 2) alignment corrections obtained intraoperatively using the cutting guides provided, compared to what was predicted in the CT generated pre-operative plans. This is a retrospective study looking at 36 patients who underwent total ankle arthroplasty using a CT generated pre-operative planning system between July 2015 and December 2017. Personalized pre-operative planning data was obtained from the implant company. Two evaluators took measurements of the angle corrected using pre- and post-operative weight bearing ankle AP X-rays. All patients had a minimum three-month follow-up with weightbearing postoperative radiographs. The actual correction calculated from the radiographic assessment was compared with the predicted angles obtained from pre-operative plans. The predicted and predicted alternative component sizes and actual sizes used were also compared. If either a predicted or predicted alternative size was implanted, we considered it to be accurate. Average age for all patients was 64 years (range 40–83), with a body mass index of 28.2 ± 5.6. All surgeries were performed by two foot and ankle surgeons. The average total surgical time was 110 ± 23 minutes. Pre-operative alignment ranged from 36.7 degrees valgus to 20 degrees varus. Average predicted coronal alignment correction was 0.8 degrees varus ± 9.3 degrees (range, 18.2 degrees valgus to 29 degrees varus) and average correction obtained was 2.1 degrees valgus ± 11.1 degrees. Average post-op alignment was consistently within 5 degrees of neutral. There were no significant differences between the predicted alignments and the postoperative weightbearing alignments. The predicted tibia implant size was accurate in all cases. The predicted sizes were less accurate for talar implants and predicted the actual talar implant size used in 66% of cases. In all cases of predicted talar size mismatch, surgical plans predicted 1 implant size larger than used. Preliminary analyses of our data is comparable to previous studies looking at similar outcomes. However, our study had higher pre-operative deformities. Despite that, post-op alignments were consistently within 5 degress of neutral with no significant difference between the predicted and actual corrections. Tibial implant sizes are highly accurate while talar implant sizes had a trend of being one size smaller than predicted. Moreover, this effect seems to be more pronounced in the earlier cases likely reflective of increasing surgeon comfort with the implant with each subsequent case. These results confirm that pre-operative cutting guides are indeed helpful in intra-operative implant selection and positioning, however, there is still some room for innovation

Introduction. Patient-specific instruments (PSI) and surgical-guiding templates are gaining popularity as a tool for enhancing surgical accuracy in the correction of oblique bone deformities Three-dimensional virtual surgical planning technology has advanced applications in the correction of deformities of long bones and enables the production of 3D stereolithographic models and PSI based upon a patient's specific deformity. We describe the implementation of this technology in young patients who required a corrective osteotomy for a complex three-plane (oblique plane) lower-limb deformity. Materials and Methods. Radiographs and computerized tomographic (CT) scans (0.5 mm slices) were obtained for each patient. The CT images were imported into post-processing software, and virtual 3D models were created by a segmentation process. Femoral and tibial models and cutting guides with locking points were designed according to the deformity correction plan as designed by the surgeon. The models were used for preoperative planning and as an intraoperative guide. All osteotomies were performed with the PSI secured in the planned position. Results. A total of 17 patients (9 males and 8 females, average age 14.7 years [range 8–24]) comprised the study group. All of the PSI were excellent fits for the planned bone surfaces during surgery. The osteotomies matched the preoperative planning simulation and allowed for easy fixation with pre-chosen plates. No intra- or postoperative complications were encountered. Surgery time was shortened (101 minutes) and intraoperative blood loose was less compared to historical cases. Clinical and radiographic follow-up findings showed highly satisfactory alignment of the treated extremities in all 17 patients. Conclusions. The use of 3D-printed models and patient-specific cutting guides with locking points increases accuracy, shortens procedure time, reduces intraoperative blood loss, and improves the outcome of osteotomies in young patients with complex oblique bone deformities

Performance and durability of total knee arthroplasty is optimised when bone surfaces are prepared with the knee in neutral varus-valgus alignment in the anteroposterior (AP) plane. For the femur, this means resecting the surface perpendicular to the mechanical axis of the femur, which passes through the center of the femoral head and center of the knee. Because the center of the femoral head is not a reliable landmark during the operation, the distal femoral surface can be resected at 5 degrees valgus to the long axis of the femur using an intramedullary (IM) alignment rod to establish the position of the femur's long axis. The IM rod also provides the landmark for alignment of the femoral component in the flexion-extension position. Tibial alignment is established by cutting the upper surface of the tibia perpendicular to the long axis. An extramedullary (EM) rod easily can span the distance between the centers of the tibial surface at the knee and ankle to establish a reference for upper tibial surface resection via the long axis of the tibia. In cases with femoral deformity or bone disease that prevents use of an IM rod as a landmark for the long axis of the femur, plain film radiographs can be used along with intraoperative measurements and hand-held tools that are readily available in the standard total knee instrument set. Using an AP radiograph taken to include the femoral head and knee: 1.) Mark the centers of the femoral head and knee. 2.) Draw a line to connect the centerpoints. 3.) Mark the high points of the medial and lateral femoral condylar joint surfaces. 4.) Draw a line perpendicular to the mechanical axis that crosses the mark on the high point of the most prominent femoral condyle. This marks the position and alignment of the femoral implant surface. 5.) To measure the distal thickness of the femoral component and adding 10% to account for magnification of the radiograph, mark two points proximal to the two high points of the condyles and draw a line perpendicular through these two points to mark the resection line for the distal femoral surfaces. Less than the thickness of the implant will be resected from the least prominent condyle. 6.) Measure the thickness of bone to be resected and the distance between the bone surface and distal surface line. This distance represents the space between the distal femoral cutting guide and the joint surface of the deficient condyle. 7.) Insert a threaded pin into the bone surface with the measured distance protruding from the surface to set this position. 8.) Seat the distal femoral cutting guide against the protruding pin on the low side and against the surface of the femur on the high side. This aligns the distal femoral cutting guide perpendicular to the mechanical axis of the femur. 9.) Draw the AP axis from the center of the intercondylar notch posteriorly to the deepest point of the patellar groove, and use the combined cutting guide to finish the femur. 10.) Make the anterior, posterior, and bevel cuts perpendicular to the AP axis. 11.) Finally, align the tibial surface, with an IM or EM rod, to resect perpendicular to the long axis of the tibia in the AP plane and sloped 4 degrees posteriorly in the lateral plane. 12.) Once the bone surfaces are resected at the proper angle, insert the trials or spacer blocks and finish the arthroplasty with release of tight ligaments

Major aspects on long-term outcome in Total Knee Arthroplasty are the correct alignment of the implant with the mechanical load axis, the rotational alignment of the components as well as good soft tissue balancing. To reduce the variability of implant alignment and at the same time minimise the invasiveness different computer assisted systems have been introduced. To achieve accuracy as high as those of a robotic system but with a pure mechanically adjustable cutting block, the Exactech GPS system has been developed. The new concept comprises a seamlessly planning and navigation screen with an integrated optical tracking system for fast and accurate acquisition and verification of anatomical landmarks within the sterile field as well as a tiny cutting guide for accurate transfer of the planned bone resections. Using a conventional screwdriver the cutting block could be accurately aligned with the planned resection by controlling the current position of the cutting block on the navigation screen. To save time, to maximise the ease of use and to minimize the surgeon's mental workload during adjustment, a smart screwdriver (SSD) has been developed being able to automatically adjust the screws. The basic idea of the smart screwdriver is to have a system providing an automatic transfer of the planned data to the cutting guide similar to a robotic system, but with the actuators separated from the kinematic. The use of the SSD is as simple as follows: After planning of the intervention and rigid fixation of the cutting guide on the bone, the surgeon simply connects sequentially the screwdriver to all screws of the cutting guide. To further maximise the ease of use and to avoid a mix-up of different screws, an identification means has been integrated into the positioning screws as well as into the smart screwdriver. For an automated identification of the screws different technologies have been analysed as position tracking, optical recognition or wired/wireless electronics. A first prototype without screw identification has been used successfully on 4 cadaver knees. All guide positions could be adjusted automatically using the SSD. However, the absence of screw identification required that the surgeon follows indications given by the computer to turn screws sequentially. A second prototype of the smart screwdriver has successfully been built up and is able to identify the different positioning screws in less than 1s with high reliability. The identification is realised as inductive coupling of different small resonance circuits that are integrated into the screw heads and the screwdrivers tip. To adjust the cutting guide from neutral to the planned position, the screws have to be adjusted by 5 mm in average. The rotational speed of the current SSD implementation is 2 rounds per second, resulting in a mean time of about 3.5 s for each screw adjustment. The rotational accuracy of the screwdriver is ±5°. Taking into account a thread of the positioning screws of 0.7 mm, the theoretical translational error is about ±0.01 mm. Looking at the angular accuracy, the maximum distance of the screws of the current setup of the cutting block of 15 mm results in an angular error of less than ±0.05°

The Gpsystem Medacta vision system is composed of an infrared camera that produces and receives infrared rays reflected by almost 3 reflectors mounted on different rigid body devices (F=femoral, T=tibial, G=guide), in order to determine its position with an error lower than 0.35mm. Data received from this vision system are than elaborated by the Cinetique Gpsystem Version 1.0 system in order to determine the correct cutting guide positioning both for the femur and the tibia. The cutting guide is moved on different planes by 5 electric engines applied on 5 no ending screws. The first step of this system is determining, with the F and the T rigid bodies, patient’s lower limb kinematic in order to evaluate its mechanical axis, its flexion-extension range of movement and its pathological deviations. The second step is evaluating anatomical landmarks to find out the correct degrees of tibial and femoral cuts: these landmarks are the medial and lateral tibial glena, the distal femoral condyles, the posterior femoral condyles, the anterior femoral cortex, the tibial tuberosity, the Whiteside line and the epycondilar axis (each anatomical landmark is identified by multiple points in order to decrease possible errors). The third step is applying the cutting guide and the Grigid body on the femoral clamp in order to estimate the correct level for the tibial cut than, once the tibial osteotomy is done the vision system controls its correct execution and the soft tissue balancing of the knee. The fourth step is calculating with the Gpsystem the correct orientation of the femoral cutting guide and checking its positioning and cutting execution. The last step is applying the test-prosthesis verifying the mechanical axis of the knee and than assembling the definitive prosthesis. Since now we have applied 10 Cinetique knee prosthesis with the Medacta computer navigation system with good results and good positioning of the prosthesis. Medacta computer navigation system for Cinetique knee arthroplasty is innovative for its simple cutting guide and movement device both in their hardware than in their way of using and for a simpler software interface; these characteristics allows faster surgeon technique learning, shortening of surgical time and a better prosthesis positioning

Primary malignant bone tumor often requires a surgical treatment to remove the tumor and sometimes restore the anatomy using a frozen allograft. During the removal, there is a need for a highest possible accuracy to obtain a wide safe margin from the bone tumour. In case of reconstruction using a bone allograft, an intimate and precise contact at each host-graft junction must be obtained (Enneking 2001). The conventional freehand technique does not guarantee a wide safe margin nor a satisfying reconstruction (Cartiaux 2008). The emergence of navigation systems has procured a significant improvement in accuracy (Cartiaux 2010). However, their use implies some constraints that overcome their benefits, specifically for long bones. Patient-specific cutting guides become now available for a clinical use and drastically simplify the intra-operative set-up. We present the use of pre-operative assistances to produce patient-specific cutting guides for tumor resection and allograft adjustment. We also report their use in the operative room. We have developed technical tools to assist the surgeon during both pre-operative planning and surgery. First, the tumor extension is delineated on MRI images. These MRI images are then merged with Computed Tomography scans of the patient. The tumor and the CTscan are loaded in custom software that enables the surgeon to define target (desired) cutting planes around the tumor (Paul 2009) including a user-defined safe margin. Finally, cutting guides are designed on the virtual model of the patient as a mould of the bone surface surrounding the tumor, materialising the desired cutting planes. When required, a massive bone allograft is selected by comparing shapes of the considered patient's bone and available allografts. The resection planes are transferred onto the selected allograft and a second guide is designed for the allograft cutting. The virtually-designed cutting guides are then manufactured by a rapid prototyping machine using biocompatible material. This procedure has been used to excise a local recurrence of a tibial sarcoma and reconstruct the anatomy using a frozen tibial allograft. The pre-operative planning using virtual models of the patient's bone, tumor and the available allografts enabled the surgeon to localise the tumor, define the desired cutting planes and select the optimal allograft. Patient- and allograft-specific guides have been designed and manufactured. A stable and accurate positioning of guide onto the patient's tibia was made easier thanks to the plate formerly put in place during the previous surgery. An accurate positioning of the allograft cutting guide has been obtained thanks to its design. The obtained reconstruction was optimal with a adjusted allograft that was perfectly fitting the bone defect. The leg alignment was also optimally restored. Computer assistances for tumor surgery are progressively appearing. We have presented at CAOS 2010 an optical navigation system for tumor resection in the pelvis that was promising. However, such a tool is not well adapted for long bones. We have used patient-specific guides on a clinical case to assess the feasibility of the technique and check its accuracy in the resection and reconstruction. The surgeon has benefited from the 3D planning to define his strategy. He had the opportunity to select the optimal transplant for his patient and plan the same cuttings for the allograft and the patient. During the surgery, guide positioning was straightforward and accurate. The bone cuttings were very easy to perform. The use of custom guides decreases the operating time when compared to the conventional procedure since there is no need for measurements between cutting trajectories and anatomical landmarks. Furthermore, the same cutting planes were performed around the tumor and onto the allograft to obtain a transplant that optimally fills the defect. We recommend the use of such an intra-operative assistance for tumor surgery

Paediatric musculoskeletal (MSK) disorders often produce severe limb deformities, that may require surgical correction. This may be challenging, especially in case of multiplanar, multifocal and/or multilevel deformities. The increasing implementation of novel technologies, such as virtual surgical planning (VSP), computer aided surgical simulation (CASS) and 3D-printing is rapidly gaining traction for a range of surgical applications in paediatric orthopaedics, allowing for extreme personalization and accuracy of the correction, by also reducing operative times and complications. However, prompt availability and accessible costs of this technology remain a concern. Here, we report our experience using an in-hospital low-cost desk workstation for VSP and rapid prototyping in the field of paediatric orthopaedic surgery. From April 2018 to September 2022 20 children presenting with congenital or post-traumatic deformities of the limbs requiring corrective osteotomies were included in the study. A conversion procedure was applied to transform the CT scan into a 3D model. The surgery was planned using the 3D generated model. The simulation consisted of a virtual process of correction of the alignment, rotation, lengthening of the bones and choosing the level, shape and direction of the osteotomies. We also simulated and calculated the size and position of hardware and customized massive allografts that were shaped in clean room at the hospital bone bank. Sterilizable 3D models and PSI were printed in high-temperature poly-lactic acid (HTPLA), using a low-cost 3D-printer. Twenty-three operations in twenty patients were performed by using VSP and CASS. The sites of correction were: leg (9 cases) hip (5 cases) elbow/forearm (5 cases) foot (5 cases) The 3D printed sterilizable models were used in 21 cases while HTPLA-PSI were used in five cases. customized massive bone allografts were implanted in 4 cases. No complications related to the use of 3D printed models or cutting guides within the surgical field were observed. Post-operative good or excellent radiographic correction was achieved in 21 cases. In conclusion, the application of VSP, CASS and 3D-printing technology can improve the surgical correction of complex limb deformities in children, helping the surgeon to identify the correct landmarks for the osteotomy, to achieve the desired degree of correction, accurately modelling and positioning hardware and bone grafts when required. The implementation of in-hospital low-cost desk workstations for VSP, CASS and 3D-Printing is an effective and cost-advantageous solution for facilitating the use of these technologies in daily clinical and surgical practice

Introduction:. Despite over 95% long-term survivorship of TKA, 14–39% of patients express dissatisfaction due to anterior knee pain, mid-flexion instability, reduction in range of flexion, and incomplete return of function. Changing demographics with higher expectations are leading to renewed interest in patient-specific designs with the goal of restoring of normal kinematics. Improved imaging and image-processing technology coupled with rapid prototyping allow manufacturing of patient-specific cutting guides with individualized femoral and tibial components with articulating surfaces that maximize bony coverage and more closely approximate the natural anatomy. We hypothesized that restoring the articular surface and maintaining medial and lateral condylar offset of the implanted knee to that of the joint before implantation would restore normal knee kinematics. To test this hypothesis we recorded kinematics of patient-specific prostheses implanted using patient-specific cutting guides. Methods:. Preoperative CT scans were obtained from nine matched pairs of human cadaveric knees. One of each pair was randomly assigned to one of two groups: one group implanted with a standard off-the-shelf posterior cruciate-retaining design using standard cutting guides based on intramedullary alignment; the contralateral knee implanted with patient-specific implants using patient-specific cutting guides, both manufactured from the preoperative CT scans. Each knee was tested preoperatively as an intact, normal knee, by mounting the knee on a dynamic, quadriceps-driven, closed-kinetic-chain Oxford knee rig (OKR), simulating a deep knee bend from 0° to 120° flexion. Following implantation with either the standard or patient-specific implant, knees were mounted on the OKR and retested. Femoral rollback, tibiofemoral rotation, tibial adduction, patellofemoral tilt and shift were recorded using an active infrared tracking system. Results:. To reduce the effect of variability, change in each kinematic measure was quantified as the absolute difference between the normal kinematic measure and the same measure after implantation (10° flexion increments). The cumulative difference from normal kinematics was calculated by summing the area beneath the curve (Fig 2). Cumulative differences in kinematics from normal were statistically lower for the patient-specific group compared to the standard group for all measures except patellar shift (Fig 2, paired t-test). Discussion:. Knee kinematics with the patient-specific design more closely approximated normal femoral rollback and tibial adduction than knees with the standard design. Femoral rollback is significantly closer qualitatively and quantitatively to normal in specimens implanted with patient-specific designs (Figs 1). The tibia rotated internally with flexion; however, the patient-specific group more closely approximated normal rotation. The patient-specific group more closely approximated normal tibial adduction suggesting ligament balance was better restored. Due to substantial differences in articular morphology among genders, races and patients, it is impossible to provide multiple sized implants to address the full range of inter-patient variability. Patient-specific designs that remove this variation, restore normal articular geometry, and maintain alignment are more likely to result in normal kinematics. Our results support the hypothesis that knees with patient-specific implants generate kinematics more closely resembling normal knee kinematics than standard knee designs. Clinical outcome studies are necessary to determine if our results translate into better outcomes

The medial opening-wedge high tibial osteotomy (OW-HTO) is an accepted option to treat the isolated medial compartment osteoarthritis (OA) in varus knee. Despite satisfactory outcomes were described in literature, consistent complication rate has been reported and the provided accuracy of coronal alignment correction using conventional HTO techniques falls short. Patient specific instrumentations has been introduced with the aim to reduce complications and to improve the intra-operative accuracy according to the pre-operative plan, which is responsible for the clinical result of the surgery. In this talk, an overview of the clinical results of HTO patient specific instrumentation available in literature will be performed. Moreover, preliminary intra-operative and clinical results of a new customised 3-D printed cutting guide and fixation plate for OW-HTO will be presented

Recently, a new technique of custom-made cutting guides for TKA is introduced to clinical practice. However, no published data yet on the comparison between this new technique against both navigation and conventional techniques. The author prospectively compared between custom-made cutting guides, navigation and conventional techniques. A total number of 90 cases were included in this study with 30 consecutive cases for each technique. The highest number of medically unfit patients and those with articular and extra articular deformities were in custom guides groups. The results showed one case of aseptic loosening after one year in custom guides, one case of superficial infection and loose pins but with no fracture in navigation group, and higher need for blood transfusion in conventional. One case in the custom guide group had a periprosthetic fracture 3 weeks postoperatively diagnosed as insufficiency fracture after a relatively minor trauma to an osteoporotic bone. Navigation was the most accurate in alignment but custom guides was the most accurate in implant sizing and had the least bleeding. This clinical study showed some advantages of custom-made cutting guides over conventional instrumentation. It eliminated medullary guides, reduced operative time, and provided better accuracy. The technique was proved to be useful in complex cases of deformities and unfit patients

Total shoulder arthroplasty implants have evolved to include more anatomically shaped components that replicate the native state. The geometry of the humeral head is non-spherical, with the sagittal diameter of the base of the head being up to 6% (or 2.1-3.9 mm) larger than the frontal diameter. Despite this, many TSA humeral head implants are spherical, meaning that the diameter must be oversized to achieve complete coverage, resulting in articular overhang, or portions of the resection plane will remain uncovered. It is suspected that implant-bone load transfer between the backside of the humeral head and the cortex on the resection plane may yield better load-transfer characteristics if resection coverage was properly matched without overhang, thereby mitigating proximal stress shielding. Eight paired cadaveric humeri were prepared for reconstruction with a short stem total shoulder arthroplasty by an orthopaedic surgeon who selected and prepared the anatomic humeral resection plane using a cutting guide and a reciprocating sagittal saw. The humeral head was resected, and the resulting cortical boundary of the resection plane was digitized using a stylus and an optical tracking system with a submillimeter accuracy (Optotrak,NDI,Waterloo,ON). A plane was fit to the trace and the viewpoint was transformed to be perpendicular to the plane. To simulate optimal sizing of both circular and elliptical humeral heads, both circles and ellipses were fit to the filtered traces using the sum of least squares error method. Two extreme scenarios were also investigated: upsizing until 100% total coverage and downsizing until 0% overhang. Total resection plane coverage for the fitted ellipses was found to be 98.2±0.6% and fitted circles was 95.9±0.9%Cortical coverage was found to be 79.8 ±8.2% and 60.4±6.9% for ellipses and circles respectively. By switching to an ellipsoid humeral head, a small 2.3±0.3% (P < 0.001) increase in total coverage led to a 19.5±1.3%(P < 0.001) increase in cortical coverage. The overhang for fitted ellipses and circles was 1.7 ±0.7% and 3.8 ±0.8% respectively, defined as a percentage of the total enclosed area that exceeded the bounds of the humerus resections. Using circular heads results in 2.0 ±0.1% (P < 0.001) greater overhang. Upsizing until 100% resection coverage, the ellipse produced 5.4 ±3.5% (P < 0.001) less overhang than the circle. When upsizing the overhang increases less rapidly for the ellipsoid humeral head that the circular one (Figure 1). Full coverage for the head is achieved more rapidly when up-sizing with an ellipsoid head as well. Downsizing until 0% overhang, total coverage and cortical coverage were 7.5 ±2.8% (P < 0.001) and 7.9 ±8.2% (P = 0.01) greater for the ellipse, respectively. Cortical coverage exhibits a crossover point at −2.25% downsizing, where further downsizing led to the circular head providing more cortical coverage. Reconstruction with ellipsoids can provide greater total resection and cortical coverage than circular humeral heads while avoiding excessive overhang. Elliptical head cortical coverage can be inferior when undersized. These initial findings suggest resection-matched humeral heads may yield benefits worth pursuing in the next generation of TSA implant design. For any figures or tables, please contact the authors directly

Abstract Detail. Interim results on a prospective, randomised, single-blinded pilot study to compare implant alignment using a patient-matched cutting guide versus a computer-assisted navigation system following total knee arthroplasty. Purpose of Study. To compare implant alignment using a patient-matched cutting guide (Visionaire) versus a computer-assisted navigation system (CAS) following total knee arthroplasty (TKA). Description of methods. Ethics approval was sought and granted by the South African Medical Association Research Ethics Committee. Patient consent for participation was obtained. Patients were randomized to TKA using Visionaire or CAS. Mechanical alignment was evaluated pre-operatively and at 3 months with a full leg X-Ray. Operative and post-operative parameters relating to resource utilization were captured. Clinical status according to the Knee Society Clinical Rating System (KSCRS) was assessed pre-operatively and at 3 months. Adverse events were noted. An independent Contract Research Organisation was used to monitor the site. Summary of results. Ten unique patients were enrolled, of whom 5 were randomized to Visionaire and 5 to CAS. Two patients in the Visionaire group have not yet reached their 3-month assessment. No significant difference in mechanical alignment between the 2 groups at 3 months was observed. The median duration of surgery was significantly shorter for the patient-matched cutting guide group across all assessed parameters (theatre time: 117 versus 150 minutes, p=0.009; operative time: 85 versus 108 minutes, p=0.0088; tourniquet time: 73 versus 99 minutes, p=0.009; and anaesthetist time: 117 versus 150 minutes, p=0.009). No other significant differences in operative or post-operative cost-drivers were noted between the 2 groups. No significant difference in KSCRS scores between the 2 groups at 3 months was observed. Two adverse were reported, one in each group, both unrelated to the medical devices, and both of which have resolved. Conclusion. While implant alignment appears consistent and comparable in both groups at 3 months, the median duration of surgery was significantly shorter for the Visionaire group. DISCLOSURE: Assistance and funding was received from Smith & Nephew

Accurate implant alignment, prolonged operative times, array pin site infection and intra-operative fracture risk with computer assisted knee arthroplasty is well documented. This study compares the accuracy and cost-effectiveness of the pre- operative MRI based Signature custom made guides (Biomet) to intra-operative computer navigation (BrainLab Knee Unlimited). Twenty patients from a single surgeon's orthopaedic waiting list awaiting primary knee arthroplasty were identified. Patients were contacted and consented for the study and their suitability for MRI examination assessed. An MRI scan of the hip, knee and ankle was performed of the operative side following a set scanning protocol. Following MRI, patient specific femoral and tibial positioning cutting guides were manufactured. Patients then underwent arthroplasty and intra-operative computer navigation was used to measure the accuracy of the custom made, patient specific cutting guides. A cost analysis of the signature system compared with computer navigation was made. Our provisional results show that the accuracy of the pre-operative MRI patient specific femoral and tibial positioning guides was comparable to computer navigation. Pre-operative, patient specific implant positioning cutting guides were as accurate as computer navigation from analysis of our preliminary results. The potential advantages of the MRI based system are accurate pre-operative planning, reduced operating times and avoidance of pin site sepsis. However, further larger studies are required to examine this technique