The object of this study was to develop a method to assess the accuracy of an image-free total knee replacement navigation system in legs with normal or abnormal mechanical axes. A phantom leg was constructed with simulated hip and knee joints and provided a means to locate the centre of the ankle joint. Additional joints located at the midshaft of the tibia and femur allowed deformation in the flexion/extension, varus/valgus and rotational planes. Using a digital caliper unit to measure the coordinates precisely, a software program was developed to convert these local coordinates into a determination of actual leg alignment. At specific points in the procedure, information was compared between the digital caliper measurements and the image-free navigation system. Repeated serial measurements were undertaken. In the setting of normal alignment the mean error of the system was within 0.5°. In the setting of abnormal plane alignment in both the femur and the tibia, the error was within 1°. This is the first study designed to assess the accuracy of a clinically-validated navigation system. It demonstrates in vitro accuracy of the image-free navigation system in both normal and abnormal leg alignment settings

We compared the alignment of 39 total knee replacements implanted using the conventional alignment guide system with 37 implanted using a CT-based navigation system, performed by a single surgeon. The knees were evaluated using full-length weight-bearing anteroposterior radiographs, lateral radiographs and CT scans. The mean hip-knee-ankle angle, coronal femoral component angle and coronal tibial component angle were 181.8° (174.2° to 188.3°), 88.5° (84.0° to 91.8°) and 89.7° (86.3° to 95.1°), respectively for the conventional group and 180.8° (178.2° to 185.1°), 89.3° (85.8° to 92.0°) and 89.9° (88.0° to 93.0°), respectively for the navigated group. The mean sagittal femoral component angle was 85.5° (80.6° to 92.8°) for the conventional group and 89.6° (85.5° to 94.0°) for the navigated group. The mean rotational femoral and tibial component angles were −0.7° (−8.8° to 9.8°) and −3.3° (−16.8° to 5.8°) for the conventional group and −0.6° (−3.5° to 3.0°) and 0.3° (−5.3° to 7.7°) for the navigated group. The ideal angles of all alignments in the navigated group were obtained at significantly higher rates than in the conventional group. Our results demonstrated significant improvements in component positioning with a CT-based navigation system, especially with respect to rotational alignment

The biomechanical function of the anteromedial (AM) and posterolateral (PL) bundles of the anterior cruciate ligament (ACL) remains controversial. Some studies report that the AM bundle stabilises the knee joint in anteroposterior (AP) translation and rotational movement (both internal and external) to the same extent as the PL bundle. Others conclude that the PL bundle is more important than the AM in controlling rotational movement.

The objective of this randomised cohort study involving 60 patients (39 men and 21 women) with a mean age of 32.9 years (18 to 53) was to evaluate the function of the AM and the PL bundles of the ACL in both AP and rotational movements of the knee joint after single-bundle and double-bundle ACL reconstruction using a computer navigation system. In the double-bundle group the patients were also randomised to have the AM or the PL bundle tensioned first, with knee laxity measured after each stage of reconstruction. All patients had isolated complete ACL tears, and the presence of a meniscal injury was the only supplementary pathology permitted for inclusion in the trial. The KT-1000 arthrometer was used to apply a constant load to evaluate the AP translation and the rolimeter was used to apply a constant rotational force. For the single-bundle group deviation was measured before and after ACL reconstruction. In the double-bundle group deviation was measured for the ACL-deficient, AM- or PL-reconstructed first conditions and for the total reconstruction.

We found that the AM bundle in the double-bundle group controlled rotation as much as the single-bundle technique, and to a greater extent than the PL bundle in the double-bundle technique. The double-bundle technique increases AP translation and rotational stability in internal rotation more than the single-bundle technique.

Aims. The objective of this study is to assess the use of ultrasound (US) as a radiation-free imaging modality to reconstruct 3D anatomy of the knee for use in preoperative templating in knee arthroplasty. Methods. Using an US system, which is fitted with an electromagnetic (EM) tracker that is integrated into the US probe, allows 3D tracking of the probe, femur, and tibia. The raw US radiofrequency (RF) signals are acquired and, using real-time signal processing, bone boundaries are extracted. Bone boundaries and the tracking information are fused in a 3D point cloud for the femur and tibia. Using a statistical shaping model, the patient-specific surface is reconstructed by optimizing bone geometry to match the point clouds. An accuracy analysis was conducted for 17 cadavers by comparing the 3D US models with those created using CT. US scans from 15 users were compared in order to examine the effect of operator variability on the output. Results. The results revealed that the US bone models were accurate compared with the CT models (root mean squared error (RM)S: femur, 1.07 mm (SD 0.15); tibia, 1.02 mm (SD 0.13). Additionally, femoral landmarking proved to be accurate (transepicondylar axis: 1.07° (SD 0.65°); posterior condylar axis: 0.73° (SD 0.41°); distal condylar axis: 0.96° (SD 0.89°); medial anteroposterior (AP): 1.22 mm (SD 0.69); lateral AP: 1.21 mm (SD 1.02)). Tibial landmarking errors were slightly higher (posterior slope axis: 1.92° (SD 1.31°); and tubercle axis: 1.91° (SD 1.24°)). For implant sizing, 90% of the femora and 60% of the tibiae were sized correctly, while the remainder were only one size different from the required implant size. No difference was observed between moderate and skilled users. Conclusion. The 3D US bone models were proven to be closely matched compared with CT and suitable for preoperative planning. The 3D US is radiation-free and offers numerous clinical opportunities for bone visualization rapidly during clinic visits, to enable preoperative planning with implant sizing. There is potential to extend its application to 3D dynamic ligament balancing, and intraoperative registration for use with robots and navigation systems. Cite this article: Bone Joint J 2021;103-B(6 Supple A):81–86

Aims. The aim of this study was to compare the post-operative radiographic and clinical outcomes between kinematically and mechanically aligned total knee arthroplasties (TKAs). . Patients and Methods. A total of 60 TKAs (30 kinematically and 30 mechanically aligned) were performed in 60 patients with varus osteoarthritis of the knee using a navigation system. The angles of orientation of the joint line in relation to the floor, the conventional and true mechanical axis (tMA) (the line from the centre of the hip to the lowest point of the calcaneus) were compared, one year post-operatively, on single-leg and double-leg standing long leg radiographs between the groups. The range of movement and 2011 Knee Society Scores were also compared between the groups at that time. Results. The angles of orientation of the joint line in the kinematic group changed from slight varus on double-leg standing to slight valgus with single-leg standing. The mechanical axes in the kinematic group passed through a neutral position of the knee in the true condition when the calcaneus was considered. The post-operative angles of flexion and functional activity scores were significantly better in the kinematic than in the mechanical group (p < 0.003 and 0.03, respectively). Conclusion. A kinematically aligned TKA results in a joint line which has a more parallel orientation in relation to the floor during single- and double-leg standing, and more neutral weight-bearing in tMA than a mechanically aligned TKA. Cite this article: Bone Joint J 2017;99-B:640–6

Introduction. Instability is a common reason for revision after total knee arthroplasty. A balanced flexion gap is likely to enhance stability throughout the arc of motion. This is achieved differently by the gap balancing and measured resection techniques. Given similar clinical results with the two techniques, one would expect similar rotation of the femoral component in the axial plane. We assessed posterior-stabilized femoral component axial rotation placed with computer navigation and a modified gap balancing technique. We hypothesized that there would be little variation in rotation. Methods. 90 surgeons from 8 countries used a modified gap-balancing technique and the same posterior-stabilized implant for this retrospective study. Axial rotation of the femoral component was collected from a navigation system and reported relative to the posterior condylar line. Patients were stratified by their preoperative coronal mechanical alignment (≥ 3° varus, < 3° varus to < 3° valgus, and ≥ 3° valgus). Results. 2442 consecutive patients were included in the analysis; 835 with ≥ 3° varus, 1343 with < 3° varus to < 3° valgus, and 264 with ≥ 3° valgus. Mean rotation was external 2.4. 0. +/− 3.4. 0. (range, 10. 0. internal − 21. 0. external). In 16.4% of the cohort, axial rotation was set in a position of internal rotation. In 15.6% of the cohort, axial rotation was set at > 5. 0. of external rotation. Compared to both the neutral and varus groups, valgus knees required a different mean rotation to achieve a balanced flexion gap (p < .0001). Conclusion. These data show a wide range of femoral rotation was needed to achieve a rectangular flexion gap. This suggests that choosing a pre-determined femoral implant axial rotation (measured resection) may lead to flexion gap asymmetry more frequently compared to adjusting the axial rotation intraoperatively (gap-balancing). Correlation to clinical outcome scores is needed

Introduction. The objective of this study is to assess the use of ultrasound (US) as a radiation free imaging modality to reconstruct three-dimensional knee anatomy. Methods. An OEM US system is fitted with an electromagnetic (EM) tracker that is integrated into the US probe, allowing for 3D tracking of probe and femur and tibia. The raw US RF signals are acquired and using real time signal processing, bone boundaries are extracted. Bone boundaries are then combined with the EM sensor information in a 3D point cloud for both femur and tibia. Using a statistical shape model, the patient specific surface is reconstructed by optimizing bone geometry to match the point clouds. An accuracy analysis was then conducted for 11 cadavers by comparing the 3D US models to those created using CT scans. Results. The results revealed the US bone models were accurate compared to the CT models (Mean RMS: femur: 1.03±0.15 mm, tibia:1.11± 0.13). Also, femoral landmarking proved to be accurate (transepicondylar axis: 1.07±0.65°, Posterior condylar axis: 0.73±0.41° Distal condylar axis: 1.12±0.89°, Medial AP: 1.39±1.18 mm, Lateral AP: 1.56±1.15 mm, TEA width: 1.2±0.87 mm). Tibial landmarking errors were slightly higher (Posterior slope axis: 2 ±1.19° and Tubercle axis: 1.8±1.37°). The models were then used to evaluate implant sizing as, 90% of the femurs and 60% of the tibias were sized correctly, while the others were off only one size. Discussion. The 3D US bone models were proven to be accurate compared to CT and can be used for preoperative planning. 3D ultrasound is radiation free and offers numerous clinical opportunities for bone creation in minutes during their office visit, surgeon-patient pre-operative planning, implant sizing and selection, 3D dynamic ligament balancing and intra-operative registration for use with robots and navigation systems

We conducted this prospective randomised and externally evaluated study to investigate whether the use of a navigation system during total knee arthroplasty leads to significantly better results than the hand-guided technique. A total of 240 patients was included in the study. All patients received a condylar knee prosthesis. Two surgeons performed all the operations using the Stryker knee navigation system. Exclusion criteria included the necessity for the primary use of constrained implants. The results revealed a highly significant difference between the two groups in favour of navigation with regard to the mechanical axis, the frontal and sagittal femoral axis and the frontal tibial axis (p < 0.0001). The use of a navigation system was therefore shown to improve the alignment of the implant

Aims. The aim of this study was to evaluate the effects of using a portable, accelerometer-based surgical navigation system (KneeAlign2) in total knee arthroplasty (TKA) on the alignment of the femoral component, and blood loss. Patients and Methods. A total of 241 consecutive patients with primary osteoarthritis of the knee were enrolled in this prospective, randomised controlled study. There were 207 women and 34 men. The mean age of the patients was 74.0 years (57 to 89). The KneeAlign2 system was used for distal femoral resection in 121 patients (KA2 group) and a conventional intramedullary femoral guide was used in 120 patients (IM group). Results. One patient (0.8%) in the KA2 group and 19 in the IM group had an alignment which was > 3° away from the neutral mechanical axis (p < 0.01). The mean deviation from neutral alignment was 1.01° (standard deviation (. sd). 1.0°) in the KA2 group and 1.93° (. sd. 1.7°) in the IM group (p < 0.01). Blood loss was significantly less in the KA2 group compared with the IM group (784 ml (. sd. 357) versus 1071 ml (. sd. 310), p < 0.001). Conclusion. The KneeAlign2 system provides a technically straightforward method for identifying the femoral head and performing an accurate distal femoral resection at TKA with significantly less blood loss compared with a conventional intramedullary guide. Cite this article: Bone Joint J 2017;99-B:1047–52

We assessed the reliability, accuracy and variability of closed-wedge high tibial osteotomy (HTO) using computer-assisted surgery compared to the conventional technique. A total of 50 closed-wedge HTO procedures were performed using the navigation system, and compared with 50 HTOs that had been performed with the conventional technique. In the navigation group, the mean mechanical axis prior to osteotomy was varus 8.2°, and the mean mechanical axis following fixation was valgus 3.6°. On the radiographs the mean pre-operative mechanical axis was varus 7.3°, and the mean post-operative mechanical axis was valgus 2.1°. There was a positive correlation between the measured data taken under navigation and by radiographs (r > 0.3, p < 0.05). The mean correction angle was significantly more accurate in the navigation group (p < 0.002). The variability of the correction was significantly lower in the navigation group (2.3° vs 3.7°, p = 0,012). We conclude that navigation provides reliable real-time intra-operative information, may increase accuracy, and improves the precision of a closed-wedge HTO

There are several methods for evaluating stability of the joint during total knee replacement (TKR). Activities of daily living demand mechanical loading to the knee joint, not only in full extension, but also in mid-flexion. The purpose of this study was to compare the varus-valgus stability throughout flexion in knees treated with either cruciate-retaining or posterior-stabilised TKR, using an intra-operative navigation technique. A total of 34 knees underwent TKR with computer navigation, during which the investigator applied a maximum varus-valgus stress to the knee while steadily moving the leg from full extension to flexion both before and after prosthetic implantation. The femorotibial angle was measured simultaneously by the navigation system at every 10° throughout the range of movement. It was found that posterior-stabilised knees had more varus-valgus laxity than cruciate-retaining knees at all angles examined, and the differences were statistically significant at 10° (p = 0.0093), 20° (p = 0.0098) and 30° of flexion (p = 0.0252). Cite this article: Bone Joint J 2013;95-B:493–7

Objectives. We performed in vitro validation of a non-invasive skin-mounted system that could allow quantification of anteroposterior (AP) laxity in the outpatient setting. Methods. A total of 12 cadaveric lower limbs were tested with a commercial image-free navigation system using trackers secured by bone screws. We then tested a non-invasive fabric-strap system. The lower limb was secured at 10° intervals from 0° to 60° of knee flexion and 100 N of force was applied perpendicular to the tibia. Acceptable coefficient of repeatability (CR) and limits of agreement (LOA) of 3 mm were set based on diagnostic criteria for anterior cruciate ligament (ACL) insufficiency. Results. Reliability and precision within the individual invasive and non-invasive systems was acceptable throughout the range of flexion tested (intra-class correlation coefficient 0.88, CR 1.6 mm). Agreement between the two systems was acceptable measuring AP laxity between full extension and 40° knee flexion (LOA 2.9 mm). Beyond 40° of flexion, agreement between the systems was unacceptable (LOA > 3 mm). Conclusions. These results indicate that from full knee extension to 40° flexion, non-invasive navigation-based quantification of AP tibial translation is as accurate as the standard validated commercial system, particularly in the clinically and functionally important range of 20° to 30° knee flexion. This could be useful in diagnosis and post-operative evaluation of ACL pathology. Cite this article: Bone Joint Res 2013;2:233–7

Bilateral sequential total knee replacement was carried out under one anaesthetic in 100 patients. One knee was replaced using a CT-free computer-assisted navigation system and the other conventionally without navigation. The two methods were compared for accuracy of orientation and alignment of the components. There were 85 women and 15 men with a mean age of 67.6 years (54 to 83). Radiological and CT imaging was carried out to determine the alignment of the components. The mean follow-up was 2.3 years (2 to 3). The operating and tourniquet times were significantly longer in the navigation group (p < 0.001). There were no significant pre- or post-operative differences between the knee scores of the two groups (p = 0.288 and p = 0.429, respectively). The results of imaging and the number of outliers for all radiological parameters were not statistically different (p = 0.109 to p = 0.920). In this series computer-assisted navigated total knee replacement did not result in more accurate orientation and alignment of the components than that achieved by conventional total knee replacement

Between April 2004 and July 2007, we performed 241 primary total knee replacements in 204 patients using the e.motion posterior cruciate-retaining, multidirectional mobile-bearing prosthesis. Of these, 100 were carried out using an image-free navigation system, and the remaining 141 with the conventional technique. We conducted a retrospective study from the prospectively collected data of these patients to assess the early results of this new mobile-bearing design. At a mean follow-up of 49 months (32 to 71), 18 knees (7.5%) had mechanical complications of which 13 required revision. Three of these had a peri-prosthetic fracture, and were removed from the study. The indication for revision in the remaining ten was loosening of the femoral component in two, tibiofemoral dislocation in three, disassociation of the polyethylene liner in four, and a broken polyethyene liner in one. There were eight further mechanically unstable knees which presented with recurrent disassociation of the polyethylene liner. There was no significant difference in the incidence of mechanical instability between the navigation-assisted procedures (8 of 99, 8.1%) and the conventionally implanted knees (10 of 139, 7.2%). In our view, the relatively high rate of mechanical complications and revision within 30 months precludes the further use of new design of knee replacement

The aim of this prospective single-centre study was to assess the difference in clinical outcome between total knee replacement (TKR) using computerised navigation and that of conventional TKR. We hypothesised that navigation would give a better result at every stage within the first five years. A total of 195 patients (195 knees) with a mean age of 70.0 years (39 to 89) were allocated alternately into two treatment groups, which used either conventional instrumentation (group A, 97 knees) or a navigation system (group B, 98 knees). After five years, complete clinical scores were available for 121 patients (62%). A total of 18 patients were lost to follow-up. Compared with conventional surgery, navigated TKR resulted in a better mean Knee Society score (p = 0.008). The difference in mean Knee Society scores over time between the two groups was not constant (p = 0.006), which suggests that these groups differed in their response to surgery with time. No significant difference in the frequency of malalignment was seen between the two groups. In summary, computerised navigation resulted in a better functional outcome at five years than conventional techniques. Given the similarity in mechanical alignment between the two groups, rotational alignment may prove to be a better method of identifying differences in clinical outcome after navigated surgery

Aims

The surgical target for optimal implant positioning in robotic-assisted total knee arthroplasty remains the subject of ongoing discussion. One of the proposed targets is to recreate the knee’s functional behaviour as per its pre-diseased state. The aim of this study was to optimize implant positioning, starting from mechanical alignment (MA), toward restoring the pre-diseased status, including ligament strain and kinematic patterns, in a patient population.

We carried out a prospective randomised study to evaluate the blood loss in 60 patients having a total knee arthroplasty and divided randomly into two equal groups, one having a computer-assisted procedure and the other a standard operation. The surgery was carried out by a single surgeon at one institution using a uniform approach. The only variable in the groups was the use of intramedullary femoral and tibial alignment jigs in the standard group and single tracker pins of the imageless navigation system in the tibia and femur in the navigated group. The mean drainage of blood was 1351 ml (715 to 2890; 95% confidence interval (CI) 1183 to 1518) in the computer-aided group and 1747 ml (1100 to 3030; CI 1581 to 1912) in the conventional group. This difference was statistically significant (p = 0.001). The mean calculated loss of haemoglobin was 36 g/dl in the navigated group versus 53 g/dl in the conventional group; this was significant at p < 0.00001. There was a highly significant reduction in blood drainage and the calculated Hb loss between the computer-assisted and the conventional techniques. This allows the ordering of less blood before the operation, reduces risks at transfusion and gives financial saving. Computer-assisted surgery may also be useful for patients in whom blood products are not acceptable

We undertook a prospective, randomised study using a non-invasive transcranial Doppler device to evaluate cranial embolisation in computer-assisted navigated total knee arthroplasty (n = 14) and compared this with a standard conventional surgical technique using intramedullary alignment guides (n = 10). All patients were selected randomly without the knowledge of the patient, anaesthetists (before the onset of the procedure) and ward staff. The operations were performed by a single surgeon at one hospital using a uniform surgical approach, instrumentation, technique and release sequence. The only variable in the two groups of patients was the use of single tracker pins of the imageless navigation system in the tibia and femur of the navigated group and intramedullary femoral and tibial alignment jigs in the non-navigated group. Acetabular Doppler signals were obtained in 14 patients in the computer-assisted group and nine (90%) in the conventional group, in whom high-intensity signals were detected in seven computer-assisted patients (50%) and in all of the non-navigated patients. In the computer-assisted group no patient had more than two detectable emboli, with a mean of 0.64 (SD 0.74). In the non-navigated group the number of emboli ranged from one to 43 and six patients had more than two detectable emboli, with a mean of 10.7 (. sd. 13.5). The difference between the two groups was highly significant using the Wilcoxon non-parametric test (p = 0.0003). Our findings show that computer-assisted total knee arthroplasty, when compared with conventional jig-based surgery, significantly reduces systemic emboli as detected by transcranial Doppler ultrasonography

Aims

Nearly 99,000 total knee arthroplasties (TKAs) are performed in UK annually. Despite plenty of research, the satisfaction rate of this surgery is around 80%. One of the important intraoperative factors affecting the outcome is alignment. The relationship between joint obliquity and functional outcomes is not well understood. Therefore, a study is required to investigate and compare the effects of two types of alignment (mechanical and kinematic) on functional outcomes and range of motion.

Aim. We aim to compare post-operative length of stay and cardiopulmonary morbidity in patients randomised to either navigated or conventional total knee arthroplasty (TKA). Method. Patients undergoing primary TKA for osteoarthritis were prospectively assigned randomly to either navigation-guided or control groups and blinded to this. All patients received a PFC implant (DePuy, Warsaw, IN). In the control group the standard femoral intramedullary and tibial extramedullary alignment rod was used. In the navigation group, the BrainLab (Munich, Germany) navigation system was used. All operations were carried out by one of two consultant orthopaedic knee surgeons. Length of post operative hospital stay and the development of cardiopulmonary complication were recorded and groups compared. Results. 95 patients were recruited (53 control vs 42 navigated). Patient demographics were similar in both groups. Mean length of stay was 7 days in the control group (range 3-101), 5 days in the navigation group (range 3-10). The mode was 4 days in both groups. 7 patients(13%) stayed for >7 days in the control group, 3 patients (2%) stayed >7 days in the navigation group(p=0.339). 4 patients(8%) required >10 days inpatient stay in the control group, 0 patients required to stay in hospital for longer than 10 days in the navigation group(p=0.069). The causes for the length of stay exceeding 10 days were pulmonary embolus in 3 patients, and chest infection in 1 patient. Conclusions. Patients undergoing navigation-guided TKA required shorter post-operative inpatient stays than those undergoing arthroplasty using conventional techniques. Fewer patients in the navigation group required stays longer than 7 or 10 days. The difference in post-operative stay was associated with fewer respiratory complications in the navigated group