We investigated the extent to which improved balance relative to pain relief correlates with the success of total knee replacement (TKR). A total of 81 patients were recruited to the study: 16 men (19.8%) and 65 women (80.2%). Of these, 62 patients (10 men, 52 women) with a mean age of 73 (57 to 83) underwent static and dynamic assessment of balance pre-operatively and one year post-operatively. The parameters of balance were quantified using commercially available and validated equipment. Motor function and self-reported outcome were also assessed. There was a significant improvement in dynamic balance (p < 0.001) one year after TKR, and better balance correlated with improved mobility, functional balance and increased health-related quality of life. As it seems that balance, and not only pain relief, influences the success of TKR, balance skills should be better addressed during the post-operative rehabilitation of patients who undergo TKR

Mechanical failure of spine posterior fixation in the lumbar region Is suspected to occur more frequently when the sagittal balance is not properly restored. While failures at the proximal extremity have been studied in the literature, the lumbar distal junctional pathology has received less attention. The aim of this work was to investigate if the spinopelvic parameters, which characterize the sagittal balance, could predict the mechanical failure of the posterior fixation in the distal lumbar region. All the spine surgeries performed in 2017-2019 at Rizzoli Institute were retrospectively analysed to extract all cases of lumbar distal junctional pathology. All the revision surgeries performed due to the pedicle screws pull-out, or the breakage of rods or screws, or the vertebral fracture, or the degenerative disc disease, in the distal extremity, were included in the junctional (JUNCT) group. A total of 83 cases were identified as JUNCT group. All the 241 fixation surgeries which to date have not failed were included in the control (CONTROL) group. Clinical data were extracted from both groups, and the main spinopelvic parameters were assessed from sagittal standing preoperative (pre-op) and postoperative (post-op) radiographs with the software Surgimap (Nemaris). In particular, pelvic incidence (PI), sagittal vertical axis (SVA), pelvic tilt (PT), T1 pelvic angle (TPA), sacral slope (SS) and lumbar lordosis (LL) have been measured. In JUNCT, the main failure cause was the screws pull-out (45%). Spine fixation with 7 or more levels were the most common in JUNCT (52%) in contrast to CONTROL (14%). In CONTROL, PT, TPA, SS and PI-LL were inside the recommended ranges of good sagittal balance. For these parameters, statistically significant differences were observed between pre-op and post-op (p<0.0001, p=0.01, p<0.0001, p=0.004, respectively, Wilcoxon test). In JUNCT, the spinopelvic parameters were out of the ranges of the good sagittal balance and the worsening of the balance was confirmed by the increase in PT, TPA, SVA, PI-LL and by the decrease of LL (p=0.002, p=0.003, p<0.0001, p=0.001, p=0.001, respectively, paired t-test) before the revision surgery. TPA (p=0.003, Kolmogorov-Smirnov test) and SS (p=0.03, unpaired t-test) differed significantly in pre-op between JUNCT and CONTROL. In post-op, PI-LL was significantly different between JUNCT and CONTROL (p=0.04, unpaired t-test). The regression model of PT vs PI was significantly different between JUNCT and CONTROL in pre-op (p=0.01, Z-test). These results showed that failure is most common in long fused segments, likely due to long lever arms leading to implant failure. If the sagittal balance is not properly restored, after the surgery the balance is expected to worsen, eventually leading to failure: this effect was confirmed by the worsening of all the spinopelvic parameters before the revision surgery in JUNCT. Conversely, a good sagittal balance seems to avoid a revision surgery, as it is visible is CONTROL. The mismatch PI-LL after the fixation seems to confirm a good sagittal balance and predict a good correction. The linear regression of PT vs PI suggests that the spine deformity and pelvic conformation could be a predictor for the failure after a fixation

Aims. Intraoperative pressure sensors allow surgeons to quantify soft-tissue balance during total knee arthroplasty (TKA). The aim of this study was to determine whether using sensors to achieve soft-tissue balance was more effective than manual balancing in improving outcomes in TKA. Methods. A multicentre randomized trial compared the outcomes of sensor balancing (SB) with manual balancing (MB) in 250 patients (285 TKAs). The primary outcome measure was the mean difference in the four Knee injury and Osteoarthritis Outcome Score subscales (ΔKOOS. 4. ) in the two groups, comparing the preoperative and two-year scores. Secondary outcomes included intraoperative balance data, additional patient-reported outcome measures (PROMs), and functional measures. Results. There was no significant difference in ΔKOOS. 4. between the two groups at two years (mean difference 0.4 points (95% confidence interval (CI) -4.6 to 5.4); p = 0.869), and multiple regression found that SB was not associated with a significant ΔKOOS. 4. (0.2-point increase (95% CI -5.1 to 4.6); p = 0.924). There were no significant differences between groups in other PROMs. Six-minute walking distance was significantly increased in the SB group (mean difference 29 metres; p = 0.015). Four-times as many TKAs were unbalanced in the MB group (36.8% MB vs 9.4% SB; p < 0.001). Irrespective of group assignment, no differences were found in any PROM when increasing ICPD thresholds defined balance. Conclusion. Despite improved quantitative soft-tissue balance, the use of sensors intraoperatively did not differentially improve the clinical or functional outcomes two years after TKA. These results question whether a more precisely balanced TKA that is guided by sensor data, and often achieved by more balancing interventions, will ultimately have a significant effect on clinical outcomes. Cite this article: Bone Joint J 2022;104-B(5):604–612

The Coronal Plane Alignment of the Knee (CPAK) is a recent method for classifying knees using the hip-knee-ankle angle and joint line obliquity to assist surgeons in selection of an optimal alignment philosophy in total knee arthroplasty (TKA)1. It is unclear, however, how CPAK classification impacts pre-operative joint balance. Our objective was to characterise joint balance differences between CPAK categories. A retrospective review of TKA's using the OMNIBotics platform and BalanceBot (Corin, UK) using a tibia first workflow was performed. Lateral distal femoral angle (LDFA) and medial proximal tibial angle (MPTA) were landmarked intra-operatively and corrected for wear. Joint gaps were measured under a load of 70–90N after the tibial resection. Resection thicknesses were validated to recreate the pre-tibial resection joint balance. Knees were subdivided into 9 categories as described by MacDessi et al.1 Differences in balance at 10°, 40° and 90° were determined using a one-way 2-tailed ANOVA test with a critical p-value of 0.05. 1124 knees satisfied inclusion criteria. The highest proportion of knees (60.7%) are CPAK I with a varus aHKA and Distal Apex JLO, 79.8% report a Distal Apex JLO and 69.3% report a varus aHKA. Greater medial gaps are observed in varus (I, IV, VII) compared to neutral (II, V, VIII) and valgus knees (III, VI, IX) (p<0.05 in all cases) as well as in the Distal Apex (I, II, III) compared to Neutral groups (IV, V, VI) (p<0.05 in all cases). Comparisons could not be made with the Proximal Apex groups due to low frequency (≤2.5%). Significant differences in joint balance were observed between and within CPAK groups. Although both hip-knee-ankle angle and joint line orientation are associated with joint balance, boney anatomy alone is not sufficient to fully characterize the knee

Aims. The use of technology to assess balance and alignment during total knee surgery can provide an overload of numerical data to the surgeon. Meanwhile, this quantification holds the potential to clarify and guide the surgeon through the surgical decision process when selecting the appropriate bone recut or soft tissue adjustment when balancing a total knee. Therefore, this paper evaluates the potential of deploying supervised machine learning (ML) models to select a surgical correction based on patient-specific intra-operative assessments. Methods. Based on a clinical series of 479 primary total knees and 1,305 associated surgical decisions, various ML models were developed. These models identified the indicated surgical decision based on available, intra-operative alignment, and tibiofemoral load data. Results. With an associated area under the receiver-operator curve ranging between 0.75 and 0.98, the optimized ML models resulted in good to excellent predictions. The best performing model used a random forest approach while considering both alignment and intra-articular load readings. Conclusion. The presented model has the potential to make experience available to surgeons adopting new technology, bringing expert opinion in their operating theatre, but also provides insight in the surgical decision process. More specifically, these promising outcomes indicated the relevance of considering the overall limb alignment in the coronal and sagittal plane to identify the appropriate surgical decision

Aims. Total knee arthroplasty (TKA) using functional alignment aims to implant the components with minimal compromise of the soft-tissue envelope by restoring the plane and obliquity of the non-arthritic joint. The objective of this study was to determine the effect of TKA with functional alignment on mediolateral soft-tissue balance as assessed using intraoperative sensor-guided technology. Methods. This prospective study included 30 consecutive patients undergoing robotic-assisted TKA using the Stryker PS Triathlon implant with functional alignment. Intraoperative soft-tissue balance was assessed using sensor-guided technology after definitive component implantation; soft-tissue balance was defined as intercompartmental pressure difference (ICPD) of < 15 psi. Medial and lateral compartment pressures were recorded at 10°, 45°, and 90° of knee flexion. This study included 18 females (60%) and 12 males (40%) with a mean age of 65.2 years (SD 9.3). Mean preoperative hip-knee-ankle deformity was 6.3° varus (SD 2.7°). Results. TKA with functional alignment achieved balanced medial and lateral compartment pressures at 10° (25.0 psi (SD 6.1) vs 23.1 psi (SD 6.7), respectively; p = 0.140), 45° (21.4 psi (SD 5.9) vs 20.6 psi (SD 5.9), respectively; p = 0.510), and 90° (21.2 psi (SD 7.1) vs 21.6 psi (SD 9.0), respectively; p = 0.800) of knee flexion. Mean ICPD was 6.1 psi (SD 4.5; 0 to 14) at 10°, 5.4 psi (SD 3.9; 0 to 12) at 45°, and 4.9 psi (SD 4.45; 0 to 15) at 90° of knee flexion. Mean postoperative limb alignment was 2.2° varus (SD 1.0°). Conclusion. TKA using the functional alignment achieves balanced mediolateral soft-tissue tension through the arc of knee flexion as assessed using intraoperative pressure-sensor technology. Further clinical trials are required to determine if TKA with functional alignment translates to improvements in patient satisfaction and outcomes compared to conventional alignment techniques. Cite this article: Bone Joint J 2021;103-B(3):507–514

Aims. A significant percentage of patients remain dissatisfied after total knee arthroplasty (TKA). The aim of this study was to determine whether the sequential addition of accelerometer-based navigation for femoral component preparation and sensor-guided ligament balancing improved complication rates, radiological alignment, or patient-reported outcomes (PROMs) compared with a historical control group using conventional instrumentation. Methods. This retrospective cohort study included 371 TKAs performed by a single surgeon sequentially. A historical control group, with the use of intramedullary guides for distal femoral resection and surgeon-guided ligament balancing, was compared with a group using accelerometer-based navigation for distal femoral resection and surgeon-guided balancing (group 1), and one using navigated femoral resection and sensor-guided balancing (group 2). Primary outcome measures were Patient-Reported Outcomes Measurement Information System (PROMIS) and Knee injury and Osteoarthritis Outcome (KOOS) scores measured preoperatively and at six weeks and 12 months postoperatively. The position of the components and the mechanical axis of the limb were measured postoperatively. The postoperative range of motion (ROM), haematocrit change, and complications were also recorded. Results. There were 194 patients in the control group, 103 in group 1, and 74 in group 2. There were no significant differences in baseline demographics between the groups. Patients in group 2 had significantly higher baseline mental health subscores than control and group 1 patients (53.2 vs 50.2 vs 50.2, p = 0.041). There were no significant differences in any PROMs at six weeks or 12 months postoperatively (p > 0.05). There was no difference in the rate of manipulation under anaesthesia (MUA), complication rates, postoperative ROM, or blood loss. There were fewer mechanical axis outliers in groups 1 and 2 (25.2%, 14.9% respectively) versus control (28.4%), but this was not statistically significant (p = 0.10). Conclusion. The sequential addition of navigation of the distal femoral cut and sensor-guided ligament balancing did not improve short-term PROMs, radiological outcomes, or complication rates compared with conventional techniques. The costs of these added technologies may not be justified. Cite this article: Bone Joint J 2020;102-B(6 Supple A):24–30

Aims. The results of kinematic total knee arthroplasty (KTKA) have been reported in terms of limb and component alignment parameters but not in terms of gap laxities and differentials. In kinematic alignment (KA), balance should reflect the asymmetrical balance of the normal knee, not the classic rectangular flexion and extension gaps sought with gap-balanced mechanical axis total knee arthroplasty (MATKA). This paper aims to address the following questions: 1) what factors determine coronal joint congruence as measured on standing radiographs?; 2) is flexion gap asymmetry produced with KA?; 3) does lateral flexion gap laxity affect outcomes?; 4) is lateral flexion gap laxity associated with lateral extension gap laxity?; and 5) can consistent ligament balance be produced without releases?. Patients and Methods. A total of 192 KTKAs completed by a single surgeon using a computer-assisted technique were followed for a mean of 3.5 years (2 to 5). There were 116 male patients (60%) and 76 female patients (40%) with a mean age of 65 years (48 to 88). Outcome measures included intraoperative gap laxity measurements and component positions, as well as joint angles from postoperative three-foot standing radiographs. Patient-reported outcome measures (PROMs) were analyzed in terms of alignment and balance: EuroQol (EQ)-5D visual analogue scale (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS Joint Replacement (JR), and Oxford Knee Score (OKS). Results. Postoperative limb alignment did not affect outcomes. The standing hip-knee-ankle (HKA) angle was the sole positive predictor of the joint line convergence angle (JLCA) (p < 0.001). Increasing lateral flexion gap laxity was consistently associated with better outcomes. Lateral flexion gap laxity did not correlate with HKA angle, the JLCA, or lateral extension gap laxity. Minor releases were required in one third of cases. Conclusion. The standing HKA angle is the primary determinant of the JLCA in KTKA. A rectangular flexion gap is produced in only 11% of cases. Lateral flexion gap laxity is consistently associated with better outcomes and does not affect balance in extension. Minor releases are sometimes required as well, particularly in limbs with larger preoperative deformities. Cite this article: Bone Joint J 2019;101-B:331–339

Aims. It is unknown whether kinematic alignment (KA) objectively improves knee balance in total knee arthroplasty (TKA), despite this being the biomechanical rationale for its use. This study aimed to determine whether restoring the constitutional alignment using a restrictive KA protocol resulted in better quantitative knee balance than mechanical alignment (MA). Methods. We conducted a randomized superiority trial comparing patients undergoing TKA assigned to KA within a restrictive safe zone or MA. Optimal knee balance was defined as an intercompartmental pressure difference (ICPD) of 15 psi or less using a pressure sensor. The primary endpoint was the mean intraoperative ICPD at 10° of flexion prior to knee balancing. Secondary outcomes included balance at 45° and 90°, requirements for balancing procedures, and presence of tibiofemoral lift-off. Results. A total of 63 patients (70 knees) were randomized to KA and 62 patients (68 knees) to MA. Mean ICPD at 10° flexion in the KA group was 11.7 psi (SD 13.1) compared with 32.0 psi in the MA group (SD 28.9), with a mean difference in ICPD between KA and MA of 20.3 psi (p < 0.001). Mean ICPD in the KA group was significantly lower than in the MA group at 45° and 90°, respectively (25.2 psi MA vs 14.8 psi KA, p = 0.004; 19.1 psi MA vs 11.7 psi KA, p < 0.002, respectively). Overall, participants in the KA group were more likely to achieve optimal knee balance (80% vs 35%; p < 0.001). Bone recuts to achieve knee balance were more likely to be required in the MA group (49% vs 9%; p < 0.001). More participants in the MA group had tibiofemoral lift-off (43% vs 13%; p < 0.001). Conclusion. This study provides persuasive evidence that restoring the constitutional alignment with KA in TKA results in a statistically significant improvement in quantitative knee balance, and further supports this technique as a viable alternative to MA. Cite this article: Bone Joint J. 2020;102-B(1):117–124

Background. Achieving good ligament balance in total knee arthroplasty (TKA) is essential to prevent early failure and revision surgery. Poor balance and instability are well-defined, however, an ideal ligament balance target across all patients is not well-understood. In this study we investigate the achieved ligament balance using an imageless, intra-operative dynamic balancing tool and its relation to patient reported outcomes. Methods. A prospective, multi-surgeon, multi-center study investigated the use of a dynamic ligament-balancing tool in combination with a robotic-assisted navigation platform using the APEX knee (OMNI-Corin, Raynham MA). After all resections, the femoral trial and a computer-controlled tensioning device in place of the tibial tray was inserted into the knee joint. The difference in medial and lateral (ML) gaps when balancing the knee under constant load at extension (10°), mid-flexion (30°) and flexion (90°) was captured. Patients completed the KOOS questionnaire at 3 months ± 2 weeks post-surgery and considered the past 7 days as a timeframe for responses. Pearson's correlation was used to determine linear correlations between factors and ANOVA tests were used to determine differences in categorical data. Results. Thirty patients have currently completed 3 months KOOS questionnaires for analysis (age: 68±9.3yrs, Male: 43%). Strong correlations were found between the difference in ML gap for KOOS symptoms and pain in extension (r=−0.54, p=0.002, r=−0.50, p=0.005, respectively) and mid flexion (r=−0.52, p=0.003, r=−0.48, p=0.007, respectively), but not in full flexion (r=−0.13, p=0.5, r=−0.23, p=0.22, respectively). A threshold of 1.5 mm difference in joint gap under constant load was used to distinguish between balanced and more lax knees medially or laterally. Worse KOOS symptoms were found in patients with tighter lateral laxity in extension and mid flexion (△=15 points, p=0.03, △=21 points, p=0.0002, respectively) compared to the rest of the cohort, see Figure 1. Similarly, worse KOOS pain was found for tight lateral laxity in mid-flexion (△=14 points, p=0.02). No significant differences were found in full flexion or for patients with a tight medial side at any flexion angle. Stronger differences in extension and mid flexion may reflect the type of activities and range of motion most commonly encountered as a TKA patient. A younger population engaging higher demand activities may be more sensitive to coronal soft tissue balance in full flexion. Conclusion. Improved patient outcomes were found to correlate with a neutrally-balanced or tighter medial soft tissue profile compared to tighter lateral structures. These results reflect the behaviour of the native knee. The cohort investigated here is small and data collection is ongoing. Further data will be needed to determine if these results can be generalized and to investigate the potential of patient specificity in ideal ligament balancing. For any figures or tables, please contact authors directly

We have investigated whether control of balance is improved during stance and gait and sit-to-stand tasks after unilateral total hip replacement undertaken for osteoarthritis of the hip. We examined 25 patients with a mean age of 67 years (. sd. 6.2) before and at four and 12 months after surgery and compared the findings with those of 50 healthy age-matched control subjects. For all tasks, balance was quantified using angular measurements of movement of the trunk. Before surgery, control of balance during gait and sit-to-stand tasks was abnormal in patients with severe osteoarthritis of the hip, while balance during stance was similar to that of the healthy control group. After total hip replacement, there was a progressive improvement at four and 12 months for most gait and sit-to-stand tasks and in the time needed to complete them. By 12 months, the values approached those of the control group. However, trunk pitch (forwards-backwards) and roll (side-to-side) velocities were less stable (greater than the control) when walking over barriers as was roll for the sit-to-stand task, indicative of a residual deficit of balance. Our data suggest that patients with symptomatic osteoarthritis of the hip have marked deficits of balance in gait tasks, which may explain the increased risk of falling which has been reported in some epidemiological studies. However, total hip replacement may help these patients to regain almost normal control of balance for some gait tasks, as we found in this study. Despite the improvement in most components of balance, however, the deficit in the control of trunk velocity during gait suggests that a cautious follow-up is required after total hip replacement regarding the risk of a fall, especially in the elderly

Aims. High-grade dysplastic spondylolisthesis is a disabling disorder for which many different operative techniques have been described. The aim of this study is to evaluate Scoliosis Research Society 22-item (SRS-22r) scores, global balance, and regional spino-pelvic alignment from two to 25 years after surgery for high-grade dysplastic spondylolisthesis using an all-posterior partial reduction, transfixation technique. Methods. SRS-22r and full-spine lateral radiographs were collected for the 28 young patients (age 13.4 years (SD 2.6) who underwent surgery for high-grade dysplastic spondylolisthesis in our centre (Scottish National Spinal Deformity Service) between 1995 and 2018. The mean follow-up was nine years (2 to 25), and one patient was lost to follow-up. The standard surgical technique was an all-posterior, partial reduction, and S1 to L5 transfixation screw technique without direct decompression. Parameters for segmental (slip percentage, Dubousset’s lumbosacral angle) and regional alignment (pelvic tilt, sacral slope, L5 incidence, lumbar lordosis, and thoracic kyphosis) and global balance (T1 spino-pelvic inclination) were measured. SRS-22r scores were compared between patients with a balanced and unbalanced pelvis at final follow-up. Results. SRS-22r domain and total scores improved significantly from preoperative to final follow-up, except for the mental health domain that remained the same. Slip percentage improved from 75% (SD 15) to 48% (SD 19) and lumbosacral angle from 70° (SD 11) to 101° (SD 11). Preoperatively, 35% had global imbalance, and at follow-up all were balanced. Preoperatively, 63% had an unbalanced pelvis, and at final follow-up this was 32%. SRS-22r scores were not different in patients with a balanced or unbalanced pelvis. However, postoperative pelvic imbalance as measured by L5 incidence was associated with lower SRS-22r self-image and total scores (p = 0.029). Conclusion. In young patients with HGDS, partial reduction and transfixation improves local lumbosacral alignment, restores pelvic, and global balance and provides satisfactory long-term clinical outcomes. Higher SRS-22r self-image and total scores were observed in the patients that had a balanced pelvis (L5I < 60°) at two to 25 years follow-up. Cite this article: Bone Jt Open 2021;2(3):163–173

Background. Despite the success of total knee arthroplasty (TKA) restoration of normal function is often not achieved. Soft tissue balance is a major factor for poor outcomes including malalignment, instability, excessive wear, and subluxation. Computer navigation and robotic-assisted systems have increased the accuracy of prosthetic component placement. On the other hand, soft tissue balancing remains an art, relying on a qualitative feel for the balance of the knee, and is developed over years of practice. Several instruments are available to assist surgeons in estimating soft tissue balance. However, mechanical devices only measure the joint space in full extension and at 90° flexion. Further, because of lack of comprehensive characterization of the ligament balance of healthy knees, surgeons do not have quantitative guidelines relating the stability of an implanted to that of the normal knee. This study measures the ligament balance of normal knees and tests the accuracy of two mechanical distraction instruments and an electronic distraction instrument. Methods. Cadaver specimens were mounted on a custom knee rig and on the AMTI VIVO which replicated passive kinematics. A six-axis load cell and an infrared tracking system was used to document the kinematics and the forces acting on the knee. Dynamic knee laxity was measured under 10Nm of varus/valgus moment, 10Nm of axial rotational moment, and 200N of AP shear. Measurements were repeated after transecting the anterior cruciate ligament, after TKA, and after transecting the posterior cruciate ligament. The accuracy and reproducibility of two mechanical and one electronic distraction device was measured. Results. The maximum passive varus laxity measured over the range of flexion was 6.4°(±2.0) and maximum passive valgus laxity was 2.6°(±0.7), (p < 0.05). The maximum passive rotational laxity measured was 9.0°(±0.57) for internal and 14.1°(±1.6) for external rotation (p < 0.05). Average stiffness of the knee (Nm/deg) was 1.7 (varus), 2.4 (valgus), 0.8 (internal rotation), and 0.5 (external rotation). The difference in tibiofemoral gap between flexion and extension was 2.9mm (±1.6). The stiffness of the mechanical and electronic distractors was very linear over a distraction range of 0 to 6mm. At forces ranging from 40N to 120N, the accuracy and repeatability of the mechanical distractors was within 1mm, and that of the dynamic electronic distractor was 0.2mm. The electronic distractor measured the varus of the tibial cut and the distal femoral cut within 0.5°, and the rotation of the posterior femoral cut within 0.7° of surgical navigation measurements. Conclusions. The dynamic electronic distraction device was significantly more accurate than mechanical instruments and measured knee balance over the entire range of flexion. The stiffness of the normal knee was distinctly different in varus and valgus. The standard recommendation for equal medial and lateral gaps under distraction may have to be revisited. Combining implant design improvements with sophisticated balancing instruments is likely to make a significant impact on improving function after total knee arthroplasty

Soft tissue balance is important for good clinical outcome and good stability after TKA. Ligament balancer is one of the devices to measure the soft tissue balance. The objective of this study is to clarify the effect of the difference in the rotational position of the TKA balancer on medial and lateral soft tissue balance. Materials and Methods. This study included with 50 knees of the 43 patients (6 males, 37 females) who had undergone TKA with ADLER GENUS system from March 2015 to January 2017. The mean age was 71.1±8.1 years. All patients were diagnosed with medial osteoarthritis of the knee. All implants was cruciate substituted type (CS type) and mobile bearing insert. We developed a new ligament balancer that could be fixed to the tibia with keel and insert trial could be rotated on the paddle. We measured the medial and lateral soft tissue balance during TKA with the new balancer. The A-P position of the balancer was fixed on tibia in parallel with the Akagi line (A-P axis 0 group) and 20 degrees internal rotation (IR group) and 20 degrees external rotation (ER group). Soft tissue balance was measured in extension and 90 degrees of knee flexion on each rotational position. Results. The mean angle of valgus and varus in IR group, 0 group and ER group were 4.6±2.2 degrees varus, 1.9±1.6 degrees varus and 0.4±2.4 degrees varus respectively in extension, and 5.5±3.0 degrees varus, 2.1±2.2 degrees varus and 0.7±3.2 degrees varus respectively in 90 degrees of knee flexion. There were significant differences between three groups in extension (p<0.0001) and flexion (p<0.0001). In other words, when the balancer was fixed on tibia with internal rotation against the Akagi line, the soft tissue balance indicated medial tightness. Conversely, when the balancer was fixed on tibia with external rotation against the Akagi line, the soft tissue balance showed lateral tightness. The insert trial significantly rotated to opposite side against the position of balancer fixed. Discussion. Ligament balancer is used to be inserted between femur and tibia. If balancer is not fixed on tibia, it may rotated and translated during measurement. That movement made impossible to measure the correct soft tissue balance. We created a new balancer that could be fixed to the tibia with keel and the insert trial could be rotated on the paddle. Furthermore, it is possible to measure the soft tissue balance after installation of the femoral trial. As a result, it is possible to check the real soft tissue balance after implantation. In conclusion, direction of A-P axis of the ligament balancer is important to measure the correct soft tissue balance in TKA. This result means that the implantation on excessive rotation of the tibial component affects on the medial and lateral soft tissue balance in fixed type TKA. In mobile type TKA, it is possible to substitute if it is within the possible range of rotation by rotational mobile insert

Introduction/Aim. Mid-flexion instability is a well-documented, but often poorly understood cause of failure of TKA. NAVIO robotic-assisted TKA (RA-TKA) offers a novel, integrative approach as a planning, execution as well as an evaluation tool in TKA surgery. RA-TKA provides a hybrid planning technique of measured resection and gap balancing- generating a predictive soft-tissue balance model, prior to making cuts. Concurrently, the system uses a semi-active robot to facilitate both the execution and verification of the plan, as it pertains to both the static and dynamic anatomy. The goal of this study was to assess the ability of the NAVIO RA-TKA to plan, execute and deliver an individualized approach to the soft-tissue balance of the knee, specifically in the “mid-flexion” arc of motion. Materials and Methods. Between May and September 2018, 50 patients underwent NAVIO RA-TKA. Baseline demographics were collected, including age, gender, BMI, and range of motion. The NAVIO imageless technique was used to plan the procedure, including: surface-mapping of the static anatomy; objective assessment of the dynamic, soft-tissue anatomy; and then application of a hybrid of measured-resection and gap-balancing technique. Medial and lateral gaps as predicted by the software were recorded throughout the entire arc of motion at 15° increments. After executing the plan and placing the components, actual medial and lateral gaps were recorded throughout the arc of motion. Results. In the assessment of coronal-plane balance, the average deviation from the predicted plan between 0–90° was 0.9mm in both the medial and lateral compartments (range 0.5–1.2mm). In the mid-flexion arc (15–75°), final soft-tissue stability was within 1.0mm of the predictive plan (range 0.9–1.2mm). Discussion/Conclusions. In this study, NAVIO RA-TKA demonstrated a highly accurate and reproducible surgical technique to plan, execute and verify a balanced a soft-tissue envelope in TKA. Objective soft-tissue balancing of the TKA can now be performed, including the mid-flexion arc of motion. Further analysis can determine if these objective measurements will translate into improved patient-reported outcome scores

Introduction. Achieving a well-balanced midflexion and flexion soft tissue envelope is a major goal in Total Knee Arthroplasty (TKA). The definition of soft tissue balance that results in optimal outcomes, however, is not well understood. Studies have investigated the native soft tissue envelope in cadaveric specimen and have shown loosening of the knee in flexion, particularly on the lateral side. These methods however do not reflect the post TKA environment, are invasive, and not appropriate for intra-operative use. This study utilizes a digital gap measuring tool to investigate the impact of soft tissue balance in midflexion and flexion on post-operative pain. Methods. A prospective multicenter multi-surgeon study was performed in which patients underwent TKA with a dynamic ligament-balancing tool in combination with a robotic-assisted navigation platform. All surgeries were performed with APEX implants (Corin Ltd., USA) using a variety of tibia and femur first techniques. Gap measurements were acquired under load (average 80 N) throughout the range of motion during trialing with the balancing tool inserted in place of the tibial trial. Patients completed KOOS pain questionnaires at 3months±2weeks post-op. Linear correlations were investigated between KOOS pain and coronal gap measurements in midflexion (30°–60°) and flexion (>70°). T-tests were used to compare outcomes between categorical data. Results. 92 patients underwent TKA and completed questionnaires, with an average age of 68±9 years, 51% left and 57% female. No significant correlations were found between the medial and lateral gap size in midflexion or flexion and post-operative pain. Significant correlations were found between the absolute difference in the medial and lateral gaps in midflexion (r=−0.3, p=0.005) and flexion (r=−0.27, p=0.01) indicating knees with a more balance soft tissue profile reported improved pain outcomes at 3-months. Knees with less than 1mm difference in ML gap reported improved pain scores compared to those with greater gap differences in flexion (Δ=6.6, p=0.03). A significant correlation was found between the difference in average gaps in midflexion and flexion, and post-op pain (r=0.22, p=0.04) in which knees that were looser in flexion than midflexion reported improved pain outcomes. When dichotomizing these results in to looser or tighter in flexion compared to midflexion, knees that were looser reported significantly improved pain outcomes (Δ=8.2, p=0.02). Discussion and Conclusion. Improved outcomes correlated with a symmetrically balanced coronal midflexion gap and looser flexion space is consistent with the soft tissue balance of the native knee. The lack of a correlation between lateral loosening in flexion and improved outcomes may be a result of greater congruency between the femoral component and tibial insert than the native knee, preventing medial pivot lateral posterior condyle rollback motion. These results indicate that targeting the native soft tissue profile may not result in optimal outcomes when performing a TKA with a neutral tibial resection and an externally rotated femoral component. Further investigation is required to determine if these results hold with a larger data set and the effect on functional outcomes at both 3-months and longer follow-up periods. For any figures or tables, please contact authors directly

Introduction. Achieving a balanced joint with neutral alignment is not always possible in total knee arthroplasty (TKA). Intra-operative compromises such as accepting some joint imbalance, non-neutral alignment or soft-tissue release may result in worse patient outcomes, however, it is unclear which compromise will most impact outcome. In this study we investigate the impact of post-operative soft tissue balance and component alignment on postoperative pain. Methods. 135 patients were prospectively enrolled in robot assisted TKA with a digital joint tensioning tool (OMNIBotics with BalanceBot, Corin USA) (57% female; 67.0 ± 8.1 y/o; BMI: 31.9 ± 4.8 kg/m. 2. ). All surgeries were performed with a PCL sacrificing tibia or femur first techniques technique, using CR femoral components and a deep dish tibial insert (APEX, Corin USA). Gap measurements were acquired under load (average 80 N) throughout the range of motion during trialing with the tensioning tool inserted in place of the tibial trial. Component alignment parameters and post-operative joint gaps throughout flexion were recorded. Patients completed 1-year KOOS pain questionnaires. Spearman correlations and Mann-Whitney-U tests were used to investigate continuous and categorical data respectively. All analysis performed in R 3.5.3. Results. Significant correlations were found between KOOS Pain and joint balance (p < 0.05). Joint gap thresholds of an equally balanced or tighter medial compartment in extension, ±1 mm medial laxity compared to the final insert thickness in midflexion, and medio-lateral imbalance < 1.5 mm in flexion generated subgroups with significantly improved pain outcomes (median Δ = 8.3, 5.6 and 2.8 points, respectively). When all joint balance thresholds were satisfied, further improved outcomes resulted (median Δ = 11.2, p = 0.0018) (Figure 1 Left). No significant correlations were identified between femoral coronal (0.8 ± 2.1° valgus) and axial (2.1 ± 2.7° external) or tibiofemoral extension (1.1 ± 2.4° varus) and flexion (2.4 ± 2.8° varus) coronal alignments and KOOS Pain. Neutral and non-neutral femoral (±3° coronal and 0° – 5° external) and tibiofemoral (±3° coronal and −2° − 5° external) subgroups also reported no difference in KOOS pain outcome (Figure 1 Right). Discussion and Conclusion. The gap profiles identified here help build the understanding of joint balance and its relationship with outcome when using a PCL sacrificing deep dish tibial insert. Using a digitally-controlled distraction device, joint gap windows of clinical relevance were identified with statistically improved patient outcomes. By combining joint gap targets, subpopulations were identified with clinically significant improved pain outcomes. Furthermore, small changes in component alignment did not impact 1 yr pain outcomes, indicating soft tissue balance has a greater impact on outcome that alignment in the enrolled population. For any figures or tables, please contact the authors directly

Background. Despite the success of total knee arthroplasty (TKA) restoration of normal function is often not achieved. Soft-tissue balance is a major factor leading to poor outcomes including malalignment, instability, excessive wear, and subluxation. Mechanical ligament balancers only measure the joint space in full extension and at 90° flexion. This study uses a novel electronic ligament balancer to measure the ligament balance in normal knees and in knees after TKA to determine the impact on passive and active kinematics. Methods. Fresh-frozen cadaver legs (N = 6) were obtained. A standard cruciate-retaining TKA was performed using measured resection approach and computer navigation (Stryker Navigation, Kalamazoo, MI). Ligament balance was measured using a novel electronic balancer (Fig 1, XO1, XpandOrtho, Inc, La Jolla, CA, USA). The XO1 balancer generates controlled femorotibial distraction of up to 120N. The balancer only requires a tibial cut and can be used before or after femoral cuts, or after trial implants have been mounted. The balancer monitors the distraction gap and the medial and lateral gaps in real time, and graphically displays gap measurements over the entire range of knee flexion. Gap measurements can be monitored during soft-tissue releases without removing the balancer. Knee kinematics were measured during active knee extension (Oxford knee rig) and during passive knee extension under varus and valgus external moment of 10Nm in a passive test rig. Sequence of testing and measurement:. Ligament balance was recorded with the XO1 balancer after the tibial cut, after measured resection of the femur, and after soft-tissue release and/or bone resection to balance flexion-extension and mediolateral gaps. Passive and active kinematics were measured in the normal knee before TKA, after measured resection TKA, and after soft-tissue release and/or bone resection to balance flexion-extension and mediolateral gaps. Results & Discussion. Overall the changes in knee balance affected passive kinematics more than active kinematics. Correcting a tight extension gap by resecting 4 mm from the distal femur had a significant effect on femoral rollback and tibial rotation and increased the varus-valgus laxity of the knee (Fig 2). Sequential release of the MCL increased active femoral rollback and tibial internal rotation primarily in flexion (Fig 3). Combinations of bone resections with ligament release had an additive effect. For example, MCL release combined with 2 mm resection of bone at the distal femoral cut increased total valgus laxity by 8° during passive testing. However, even after balancing the flexion-extension gap and the mediolateral gap knee kinematics were significantly different from the normal knee before TKA. Conclusions. The XO1 electronic balancer was very sensitive to changes in bone resection and sequential soft-tissue releases. Intraoperative ligament balance had a significant effect on active and passive kinematics. However, balancing the flexion-extension gap and the mediolateral gap did not restore kinematics to that of the normal knee. Ligament balance can have a profound impact on postoperative function, and that current recommendations for balancing the knee likely have to be reconsidered

Fifteen-year survivorship studies demonstrate that total knee replacements have excellent survivorship, with reports of 85% to 97%. However, excellent survivorship does not equate to excellent patient reported outcomes. Noble et al. reported that 14% of their patients were dissatisfied with their outcome with more than half expressing problems with routine activities of daily living. There is also a difference in the patient's subjective assessment of outcome and the surgeon's objective assessment. Dickstein et al. reported that a third of total knee patients were dissatisfied, even though the surgeons felt that their results were excellent. Most of the patients who report lower outcome scores due so because their expectations are not being fulfilled by the total knee replacement surgery. Perhaps this dissatisfaction is a result of subtle soft tissue imbalance that we have difficulty in assessing intra-operatively and post-operatively. Soft tissue balancing techniques still rely on subjective feel for appropriate ligamentous tension by the surgeon. Surgical experience and case volume play a major role in each surgeon's relative skill in balancing the knee properly. New technology of “smart trials” with embedded microelectronics and accelerometers, used in the knee with the medial retinaculum closed, can provide dynamic, intra-operative feedback regarding knee quantitative compartment pressures and component tracking. After all bone cuts are made using the surgeon's preferred techniques, trial components with the sensored tibial trial are inserted and the knee is taken through a passive range of motion. After visualizing the resultant compartment pressures and tracking data on a graphical interface, the surgeon can decide whether to perform a soft tissue balance or minor bone recuts. If soft tissue balancing is chosen, pressure data can indicate where to perform the release and allow the surgeon to assess the pressure changes as titrated soft tissue releases are performed. A multi-center study using smart trials has demonstrated dramatically better outcomes out to three years

INTRODUCION. Appropriate soft tissue balance is an important factor for postoperative function and long survival of total knee arthroplasty(TKA). Soft tissue balance is affected by ligament release, osteophyte removal, order of soft tissue release, cutting angle of tibial surface and rotational alignment of femoral components. The purpose of this study is to know the characteristics of soft tissue balance in ACL deficient osteoarthritis(OA) knee and warning points during procedures for TKA. METHODS. We evaluated 139 knees, underwent TKA (NexGen LPS-Flex, fixed surface, Zimmer) by one surgeon (S.A.) for OA. All procedures were performed through a medial parapatellar approach. There were 49 ACL deficient knees. A balanced gap technique was used in 26 ACL deficient knees, and anatomical measured technique based on pre-operative CT was used in 23 ACL deficient knees. To compare flexion-extension gaps and medial- lateral balance during operations between the two techniques, we measured each using an original two paddles tensor (figure 1) at 20lb, 30lb and 40lb, for each knee at a 0 degree extension and 90 degree flexion. We measured bone gaps after removal of all osteophytes and cutting of the tibial surface, then we measured component gaps after insertion of femoral components. Statistical analysis was performed by t-test with significant difference defined as P<0.05. RESULTS. (1) There were 90 ACL remaining knees and 49 deficient knees. Each group's preoperative FTA was 184±4.4 degrees, 187±6.3 degrees, postoperative FTA was 174±2.7 degrees, 173±3.1 degrees, preoperative knee extension was −12.8±7.5 degrees, −14.5.±3.1 degrees, flexion was 122.4±13.7 degrees, 110.7±20.2 degrees, post-operative β angle was, 88.1±2.5 degrees, 88.5±2.5 degrees. Comparing bone gap, medial gap and lateral-medial gap at a 30lb flexion were significantly different(P<0.05). (2) Comparing component gaps using modified gap techniques (group G) and anatomical techniques (group A) in ACL deficient knees, extension of medial and lateral gaps at 30lb and 40 lb in anatomical technique was bigger. The lateral-medial gap at 30lb was bigger in anatomical techniques. (P<0.05). DISCUSSION. The present results showed that ACL deficient OA knee were looser at medial side compared with ACL remaining OA knees. It indicates that we performed medial rerelease carefully in ACL deficient TKA. When we used gap techniques, medial loosening caused malposition of femoral components, and when we used anatomical techniques, extension gap was bigger than using gap techniques because generally smaller femoral components were chosen. It is reported that lateral gaps are bigger in severe varus deformity OA than slightly deformed OA knees and the soft tissue on the medial side is not shorter. It is also reported the correlation of lateral thrust with ACL deficiency and the progression OA, and when OA is developed, lateral side becomes loose. Our study indicated that ACL deficient OA knee progress rotational instability, in addition to antero-posterior instability, and subsequent medial loosening and development of medial osteophyte. Medial preserving gap technique is recommended