Introduction. Accurate soft tissue balancing has been recognized as important as alignment of bony cut in total knee arthroplasty (TKA). In addition, using a tensor for TKA that is designed to facilitate soft tissue balance measurements throughout the range of motion with a reduced patello-femoral (PF) joint and femoral component in place, PF joint condition (everted or reduced) has been proved to have a significant effect for intra-operative soft tissue balance. On the other hand, effect of patellar height on intra-operative soft tissue balance has not been well addressed. Therefore, in the present study, we investigated the effect of patellar height by comparing intra-operative soft tissue balance of patella higher subjects (Insall-Salvati index>1) and patella lower subjects (Insall-Salvati indexâ‰/1). Materials and methods. The subjects were 30 consecutive patients (2 men, 28 women), who underwent primary PS TKA (NexGen LPS-flex PS: Zimmer, Warsaw, IN, USA) between May 2003 and December 2006. All cases were osteoarthritis with varus deformity. Preoperative Insall-Salvati index (ISI) was measured and patients were divided into two groups; the patella higher group (ISIï1/4ž1: 18 knees average ISI was 1.12) and the patella lower group (ISIâ‰/1; 12 knees average ISI was 0.94). Component gap and ligament balance (varus angle) were measured using offset-type tensor with 40lb distraction force after osteotomy with the PF joint reduced and femoral trial in place at 0, 10, 45, 90, 135 degrees of knee flexion. Data of two groups were compared using unpaired t test. Results. Component gap was increased from 0 to 90 degrees of knee flexion and decreased at 135 degrees of knee flexion in both groups. Component gaps of the patella higher group in average were 10.9, 14.3, 16.6, 18.2, 16.8 mm at 0, 10, 45, 90, 135 degrees of knee flexion, respectively. Component gaps of the patella lower group in average were 9.6, 13.6, 14.6, 15.5, 14.0 mm at 0, 10, 45, 90, 135 degrees of knee flexion, respectively. When comparing two groups, component gaps of the patella higher group showed larger trend than those of the patella lower group. Especially at 90 and 135 degrees of knee flexion, the patella higher group showed significant larger values than the patella lower group (p<0.05). Varus angles of the patella higher group in average were 2.2ï1/4Œ3.4ï1/4Œ5.0ï1/4Œ5.9ï1/4Œ6.1 degrees at 0, 10, 45, 90, 135 degrees of knee flexion, respectively. Varus angles of the patella lower group in average were 1.7ï1/4Œ2.8ï1/4Œ4.4ï1/4Œ4.9ï1/4Œ4.6 degrees at 0, 10, 45, 90, 135 degrees of knee flexion, respectively. Varus angles of the patella higher group showed slight larger trend than those of the patella lower group, however there was no significant differences between two groups. Discussion. In the present study, the patella higher group showed significant larger component gaps than the patella lower group at high flexion angles (90, 135 degree). This result suggests that smaller pressure on extensor mechanism of the patella higher group has led to larger component gaps at higher flexions. In conclusion, pre-operative measurement of ISI can help surgeons predict intra-operative soft tissue balance

Objective. Although both accurate component placement and adequate soft tissue balance have been recognized as essential surgical principle in total knee arthroplasty (TKA), the influence of intra-operative soft tissue balance on the post-operative clinical results has not been well investigated. In the present study, newly developed TKA tensor was used to evaluate soft tissue balance quantitatively. We analyzed the influence of soft tissue balance on the post-operative knee extension after posterior-stabilized (PS) TKA. Materials and Methods. Fifty varus type osteoarthritic knees implanted with PS-TKAs were subjected to this study. All TKAs were performed using measured resection technique with anterior reference method. The thickness of resected bone fragments was measured. Following each bony resection and soft tissue releases, we measured soft tissue balance at extension and flexion of the knee using a newly developed offset type tensor. This tensor device enabled quantitative soft tissue balance measurement with femoral trial component in place and patello-femoral (PF) joint repaired (component gap evaluation) in addition to the conventional measurement between osteotomized surfaces (osteotomy gap evaluation). Soft tissue balance was evaluated by the center gap (mm) and ligament balance (°; positive in varus) applying joint distraction forces at 40 lbs (178 N). Active knee extension in spine position was measured by lateral X-ray at 4 weeks post-operatively. The effect of each parameter (soft tissue balance evaluations, thickness of polyethylene insert and resected bone) on the post-operative knee extension was evaluated using simple linear regression analysis. P<0.05 was considered statistically significant. Results. The thickness of resected bone, flexion center gap and ligament balance at extension and flexion had no correlations to the knee extension angle. Thickness of polyethylene insert correlated positively to knee extension (r=0.38, p=0.007). Significant positive correlation were found between extension center gap in both osteotomy and component gap evaluation to the post-operative knee extension. The coefficient of correlations were 0.33 (p=.02) with osteotomy gap and 0.47 (p=0.0007) with component gap evaluation. Discussion and Conclusion. In the present study, extension center gap was found to positively correlate to the early post-operative knee extension. The extension center gap could be considered as the summation of the simultaneous gap from bone resections and the elongation of soft tissue envelope under joint distraction force applied by tensor. The soft tissue with the lower stiffness would be elongated more, and result in the larger center gap. Accordingly, the stiffness of the soft tissue envelope might play an important role on the magnitude of extension center gap and the post-operative knee extension. Furthermore, the center gap in component gap evaluation had higher coefficient of correlation comparing to that in osteotomy gap. Proposed component gap evaluation in soft tissue balance measurement might be more physiological and relevant to the joint condition after TKA, and useful to predict post-operative clinical results

Fifteen-year survivorship studies demonstrate that total knee replacement 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 intraoperatively and postoperatively. 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 a 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

Introductions. In cruciate-retaining total knee arthroplasty (TKA), among many factors influencing post-operative outcome, increasing the tibial slope has been considered as one of the beneficial factors to gain deep flexion because of leading more consistent femoral rollback and avoiding direct impingement of the insert against the posterior femur. In contrast, whether increasing the tibial slope is useful or not is controversial in posterior-stabilized (PS) TKA, Under such recognition, accurate soft tissue balancing is also essential surgical intervention for acquisition of successful postoperative outcomes in TKA. In order to permit soft tissue balancing under more physiological conditions during TKAs, we developed an offset type tensor to obtain soft tissue balancing throughout the range of motion with reduced patello-femoral(PF) and aligned tibiofemoral joints and have reported the relationship between intra-operative soft tissue balance and flexion angles. In this study, we therefore assessed the relationship between intra-operative soft tissue balance assessed using the tensor and the tibial slope in PS TKA. Materials and methods. Thirty patients aged with a mean 72.6 years were operated PS TKA(NexGen LPS-Flex, Zimmer, Inc. Warsaw, IN) for the varus type osteoarthritis. Following each bony resection and soft tissue release using measure resection technique, the tensor was fixed to the proximal tibia and femoral trial prosthesis was fitted. Assessment of the joint component gap (mm) and the ligament balance in varus (°)was carried out at 0, 10, 45, 90and 135degrees of knee flexion. The joint distraction force was set at 40lbs. Joint component gap change values during 10-0°,45-0°, 90-0°, 135-0° flexion angle were also calculated. The tibial slopes were measured by postoperative lateral radiograph. The correlation between the tibial slope and values of soft tissue balance were assessed using linear regression analysis. Results. Average joint component gaps were 11.2, 14.7, 16.7, 18.4 and 17.0 mm and ligament balance in varus were 2.2, 2.9, 5.3, 6.8 and 6.9°at 0, 10, 45, 90 and 135° of flexion, respectively. Average joint component gap changes were 3.5, 5.6, 7.2 and 5.7 mm at each range of motion between 10–0, 45-0, 90–0 and 135–0° of flexion, respectively. The mean tibial slope was 5.0(1.6–9.6) degrees. Joint component gap at 90 (R = 0.537, p<0.01),135(R=0.463, p<0.05) degrees of flexion, and joint component gap change value of 90–0° (R = 0.433, p<0.05) showed positive correlations with tibial slope. The other factors assessed in this study showed no correlation with tibial slope. Discussions. The joint gap toward mid-range of flexion might be measured at anterior part of the tibiofemoral joint, whereas the values of joint gap at high flexion where the femur shifted posterior due to femoral rollback were measured the widened posterior part of the joint gap. In addition, extensor mechanism as well as tibial slope might influence joint gap at deep flexion. In conclusion, even PS TKA, increasing the posterior tibial slope resulting in larger flexion gap compared to extension gap should be taken into account for the flexion-extension gap balancing

Introduction. Appropriate intraoperative soft tissue balancing is recognized to be essential in total knee arthroplasty (TKA). However, it has been rarely reported whether intraoperative soft tissue balance reflects postoperative outcomes. In this study, we therefore assessed the relationship between the intra-operative soft tissue balance measurements and the post-operative stress radiographs at a minimum 1-year follow-up in cruciate-retaining (CR) TKA, and further analyzed the postoperative clinical outcome. Methods. The subjects were 25 patients diagnosed with osteoarthritis with varus deformity and underwent primary TKA. The mean age at surgery was 72.0 ± 7.5 years (range, 47–84 years). The Surgeries were performed with the tibia first gap technique using CR-TKA (e motion, B. Braun Aesculap) and the image-free navigation system (Orthopilot). We intraoperatively measured varus ligament balance (°, varus angle; VA) and joint component gap (mm, center gap; CG) at 10° and 90° knee flexion guided by the navigation system, with the patella reduced. At a minimum 1-year follow-up, post-operative coronal laxity at extension was assessed by varus and valgus stress radiographs of the knees with 1.5 kgf using a Telos SE arthrometer (Fa Telos) and that at flexion was assessed by epicondylar view radiographs of the knees with a 1.5-kg weight at the ankle. After calculating postoperative VA and CG from measurements of radiographs, measurements and preoperative and postoperative clinical outcome, such as Knee Society Clinical Rating System (Knee score; KSS, Functional score; KSFS) and postoperative knee flexion, were analyzed statistically using linear regression models and Pearson's correlation coefficient. Results. The mean follow-up duration was 22.0 months (range, 12–36 months). The average pre-operative KSS and KSFS was 57.0 points and 62.8, respectively, and the average post-operative scores were 98.4 points and 91.5, respectively. The both scores were significantly improved. The mean preoperative knee flexion angle was 121.8°, and postoperative knee flexion angle was 124.8°.ã��The mean pre- and post-operative joint component gaps at extension and flexion were 14.4 and 14.4 mm, and 15.6 and 16.5 mm, respectively. The mean pre- and post-operative values of varus ligament balance at extension and flexion were 2.5° and 2.7°, and 1.7° and 4.4°, respectively. Regression analysis revealed that the intraoperative CG was positively correlated with the postoperative CG at both extension and flexion (R = 0.45, P < 0.05; R = 0.52, P < 0.05, respectively) and intraoperative VA was positively correlated with the postoperative VA at extension (R = 0.52, P < 0.05) (Figure 1). Furthermore, postoperative flexion angle was positively correlated with the postoperative CG and VA at flexion (R=0.43, p<0.05, R=0.44, p<0.05, respectively) (Figure 2). Conclusion. We revealed that intraoperative soft tissue balance reflect postoperative soft tissue balance in CR-TKA. Furthermore, postoperative lateral laxity at flexion may permit the improvement of postoperative flexion angle

Using a tensor for total knee arthroplasty (TKA) that is designed to facilitate soft tissue balance measurements with a reduced patello-femoral (PF) joint, we examined the influence of pre-operative deformity on intra-operative soft tissue balance during posterior-stabilized (PS) TKA. Joint component gap and varus angle were assessed at 0, 10, 45, 90 and 135° of flexion with femoral trial prosthesis placed and PF joint reduced in 60 varus type osteoarthritic patients. Joint gap measurement showed no significant difference regardless the amount of pre-operative varus alignment. With the procedures of soft tissue release avoiding joint line elevation, however, intra-operative varus angle with varus alignment of more than 20 degrees exhibited significant larger values compared to those with varus alignment of less than 20 degrees throughout the range of motion. Accordingly, we conclude that pre-operative severe varus deformity may have the risk for leaving post-operative varus soft tissue balance during PS TKA

INTRODUCTION. To obtain appropriate joint gap and soft tissue balance, and to correct the lower limb alignment are important factor to achieve success of total knee arthroplasty (TKA). A variety of computer-assisted navigation systems have been developed to implant the component accurately during TKA. Although, the effects of the navigation system on the joint gap and soft tissue balance are unclear. The purpose of the present study was to investigate the influence of accelerometer-based portable navigation system on the intraoperative joint gap and soft tissue balance. METHODS. Between March 2014 and March 2015, 36 consecutive primary TKAs were performed using a mobile-bearing posterior stabilized (PS) TKA (Vanguard RP; Biomet) for varus osteoarthritis. Of the 36 knees, 26 knees using the accelerometer-based portable computer navigation system (KneeAlign2; OrthAlign) (N group), and 10 knees using conventional alignment guide (femur side; intramedullary rod, tibia side; extramedullary guide) (C group). The intraoperative joint gap and soft tissue balance were measured using tensor device throughout a full range of motion (0°, 30°, 45°, 60°, 90°, 120°and full flexion) at 120N of distraction force. The postoperative component coronal alignment was measured with standing anteroposterior hip-to-ankle radiographs. RESULTS. The mean joint gaps at each flexion angle were maintained constant in N group, and there was a tendency of the joint gap at midflexion ranges to increase in C group. The joint gaps at 30°and 45°of flexion angle in C group were significantly larger than that of in N group. The mean soft tissue balance at 0°of flexion was significantly varus in N group than that of in C group. Postoperatively, in N group, the mean femoral component alignment was valgus 0.1°± 1.3°(range, varus 2°- valgus 3°), the mean tibial component alignment was valgus 1.1°± 1.7°(range, varus 1°- valgus 3°) to the coronal mechanical axis. In C group, the mean femoral component alignment was varus 2.3°± 1.9°(range, varus 6°- valgus 1°), the mean tibial component alignment was valgus 2.0°± 1.3°(range, 0°- valgus 5°) to the coronal mechanical axis. There was statistically significant difference in femoral component alignment, there was no statistically significant difference in tibial component alignment. DISCUSSION AND CONCLUSION. The present study demonstrated that navigation-assisted TKA was prevented the joint gaps from increasing at 30°and 45°of flexion. However, it was difficult to achieve soft tissue balance at extension. In conventional TKA, the femoral component alignment was usually varus. In contrast, accelerometer-based portable navigation system is superior to implant the femoral component accurately. However, there were several cases that femoral component alignment is valgus because of a variation in the accuracy of this navigation system. Surgeons should be aware of difficulty to accomplish all of appropriate joint gap and soft tissue balance, and lower limb alignment in navigation-assisted TKA

Introduction. Balancing of joint gap is a prerequisite in total knee arthroplasty (TKA). Recently, the tensor has been developed which can measure the joint gap with the patellofemoral joint reduced for more physiological assessment, and the results for osteoarthritis (OA) patients indicated that the flexion gap is larger than the extension gap during posterior-stabilized (PS) TKA. However with respect to the rheumatoid arthritis (RA) patients, the soft tissue balance in TKA is still unknown. Therefore, the purpose of this study was toinvestigate thecharacteristics of thejoint gap during TKAsurgeryforpatients with RA. Methods. We implanted 90 consecutive knees with a PS TKA using a NexGen LPS-flex (Zimmer, Warsaw, IN). OA was the underlying disease in 60 knees and RA was the disease in30 knees. Surgical procedure. We performed all operations with a measured resection technique. The rotational position of the femoral component was determined based on the epicondylar axis of the femur with anterior reference for anteroposterior sizing. Joint gap measurements. After bone cuts and soft tissue balancing, we measured the joint gap with the femoral component in position using seesaw-type tenser device with the patella reduced position after repair of the medial arthrotomy with a few stitches. The center width and asymmetry (tilting) of joint gaps under 40-lb distracting force were measured at 0 degree extension and 90 degrees of knee flexion. Results. The changes in the joint gap from 0 to 90 degrees were 3.2 ± 0.3 mm in OA group and 4.3 ± 0.4 mm in RA group. The increase of joint gap from 0 to 90 degrees in RA was significantly larger than that in OA group (Figure 1). The tilting angle of the joint gap (varus gap expressed as positive values) at 90 degrees of knee flexion in RA group (5.3 ± 0.5 degrees) was significantly larger than that in OA group (2.6 ± 0.4 degrees) (Figure 2). In RA group, there was a positive correlation (r= 0.34, p <0.05) between the increase of joint gap from 0 to 90 degrees and the tilting angle of the joint gap at 90 degrees of knee flexion (Figure 3). Discussion. In this study, the increase of joint gap from 0 to 90 degrees in RA group was significantly larger than that in OA group. In addition, the lateral gap in knee flexion, calculated from the tilting angle of the joint gap, was significantly larger in RA group and was correlated with the increase of joint gap from 0 to 90 degrees of knee flexion. These differences could be attributed to reduced stiffness of the lateral structure, such as lateral collateral ligament and popliteofibular ligament, as well as the extensor mechanism in patients with RA. Therefore, it is necessary to considerthe individual stiffness of soft tissues, together with the applied tension, to decide the rotation of femoral component by reference to the flexion gap during TKA for RA patients

The influence of soft tissue balance in mobile-bearing posterior-stabilized (PS) total knee arthroplasty (TKA) on the patellofemoral (PF) joint was investigated in thirty varus-type osteoarthritis patients. Intraoperative soft tissue balance including joint component gap and varus/valgus ligament balance and the medial/lateral patellar pressure were measured throughout the range of motion after the femoral component placement and the PF joint repair. The lateral patellar pressure, which was significantly higher than the medial side in the flexion arc, showed inverse correlation with the lateral laxity at 60° and 90° of flexion. The lateral patellar pressure at 120° and 135° of flexion also inversely correlated with the postoperative flexion angle. Surgeons should take medial and lateral laxity into account when considering PF joint kinematics influencing postoperative flexion angle in PS TKA

Objective. The goal of total knee arthroplasty (TKA) is to achieve a stable and well-aligned tibiofemoral and patello-femoral (PF) joint, aiming at long-term clinical patient satisfaction. The surgical principles of both cruciate retaining (CR) and posterior stabilized (PS) TKA are accurate osteotomy and proper soft tissue balancing. We have developed an offset-type tensor, and measured intra-operative soft tissue balance under more physiological joint conditions with femoral component in place and reduced PF joint. In this study, we measured intra-operative soft tissue balance and assessed the early post-operative knee joint stability quantitatively, and compared these parameters between CR and PS TKA. Material and Method. Seventy patients with varus osteoarthritis of the knee underwent TKAs (35 CR TKAs: CR and 35 PS TKAs: PS). Mean varus deformity in standing position was 9.8 degrees in CR, and 10.7 degrees in PS (p = 0.45). All TKAs were performed by a single surgeon with measured resection technique. The external rotation of posterior femoral condyle osteotomy was performed according to surgical epicondylar axis (SEA) in pre-operative CT. We measured intra-operative soft tissue balance using an offset-type tensor with 40 lbs of joint distraction force at 0, 10, 30, 45, 60, 90, 120 and 135 degrees of flexion. The joint component gap (mm) and varus angle (degrees) were measured at each flexion angle. Four weeks after operation, we evaluated the knee stability at extension by varus and valgus stress radiography using Telos (10 kg) and at flexion by epicondylar view with 1.5 kg weight at the ankle. We measured joint separation distance at medial as medial joint looseness (MJL) and at lateral as lateral joint looseness (LJL). Joint looseness was defined as the average of MJL and LJL. Intra-operative measurements and post-operative joint stabilities were compared between CR and PS using unpaired t-test. Result. Joint gap kinematics was different between CR and PS (figure 1). Joint component gap in PS were significantly higher than CR from 30 to 120 degrees of flexion. Post-operative joint looseness were 2.7 mm and 3.7 mm at extension (p = 0.001, figure 2), and 1.1 mm and 1.9 mm at flexion (p = 0.021, figure 3) in CR and PS TKAs each respectively. At both extension and flexion, PS showed significantly higher joint looseness, especially with the higher MJL in PS comparing with CR. Discussion. We found significant differences in gap kinematics and also in the early post-operative joint stability between CR and PS. In the PS TKAs, component gaps were significantly larger than those in CR TKAs at mid-flexion to deep flexion of the knee. These different characteristics of the intra-operative soft tissue balance would be a possible reason for the differences in the post-operative joint stability between CR and PS TKAs. Our results suggested that TKAs performed by measured resection technique have significantly higher joint stability with CR than PS. These findings would be important issues in choosing prosthesis and operative technique. Conclusion. With measured resection technique, CR TKAs had more consistent joint gap kinematics and higher joint stability after surgery comparing to PS TKAs

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

Purpose. Despite total knee arthroplasty (TKA) is a successful surgical procedure with end-stage knee osteoarthritis, approximately 20% of the patients who underwent primary TKA were still dissatisfied with the outcome. Thereby, numerous literatures have confirmed the relationship between soft tissue balancing and clinical result to improve this pressing issue. Recently, there has been an increased research interest in patient-reported outcome measures (PROMs) after TKA. However, there is little agreement on the association between soft tissue balancing and PROMs. Therefore, the purpose of this study was to determine whether intraoperative soft tissue balancing affected PROMs after primary TKA. We hypothesized that soft tissue balancing would be a predictive factor for postoperative PROMs at one-year post-surgery. Patients and Methods. The study included 20 knees treated for a varus osteoarthritic deformity using a cruciate-retaining TKA (Scorpio NRG) with a polyethylene insert thickness of 8 mm retrospectively. Following the osteotomy using the measured resection technique, the extension gap was measured with a femoral trial by using an electric tensor. This instrument could estimate the soft tissue balance applying continuous distraction force simultaneously from 0 to 40 lbf with an accuracy of the 0.1 lbf. We evaluated the association between a distraction force required for an extension gap of 8 mm, and the following potentially affected factors at one year postoperatively: knee flexion angle using a protractor with one degree increments; radiographic parameters of component alignment, namely the femoral and tibial component medial angle; and the Japanese Knee Osteoarthritis Measure (JKOM). This is a disease-specific and self-administered questionnaire, reflecting the specificity of the Japanese cultural lifestyle, consisting of 25 items scored from 0 to 100 points, with 100 points being worst. Outcomes. The median knee flexion angle was 130 degrees with the femoral and tibial component of 97 and 89 degrees, respectively. For an extension gap of 8 mm, a verified value of a distraction force did not demonstrate a correlation with, knee flexion angle (p = 0.29) or with the femoral (p = 0.20), and tibial component position (p = 0.09). The median JKOM totaled 20 points across 4 domains: pain and stiffness, condition in daily life, general activities, and health conditions with 5, 8, 2.5, and 2 points respectively. There was significant correlation between a required force and the JKOM (r. s. = 0.53, p = 0.02), and notably the domain of health conditions exhibited the highest coefficient of determination (r. s. = 0.54, p = 0.01). Discussion. This study highlights that distraction force for an extension gap of 8 mm is an independent variable in component position or knee flexion angle. We found that soft tissue balancing could influence short term postoperative PROMs. Our results will contribute to a better understanding of outcomes after TKA. This is a particularly critical issue as feasible strategies to avoid a persistent joint stiffness would improve long-term function after TKA and patient satisfaction

Fifteen-year survivorships 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. Total knee imbalance with either too tight or loose soft tissues account for up to 54% of revisions in one series. This may account for many of the 20% unsatisfactory total knee arthroplasty outcomes. Soft tissue balancing technique is more like an art. The surgeon relies on subjective feel for appropriate ligamentous tension. 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, intraoperative 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 sensor 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, imbalance situations such as a too tight MCL or ITB, an incompetent or too tight PCL, or malrotated femoral or tibial component can be identified. A decision can be made as to whether to recut the bone to realign components, do a soft tissue release, or a combination of both. Soft tissue releases can be titrated while observing equalizing compartment pressures. Sensor feedback improves soft tissue balancing. More balanced compartments occur using a sensor trial than with standard soft tissue balancing technique blinded to sensor information. A multicenter three year study has shown that having the medial and lateral compartments in flexion and extension balanced within 15 pounds provides better outcomes. Patients with quantitatively balanced TKA with <15lbf mediolateral load differential have better forgotten knee scores at six weeks and six months. Use of smart trials is a new approach to total knee replacement surgery allowing fine tune balancing and takes soft tissue balancing from art to science

Background. Osteophytes in the posterior compartment of the knee pose a challenge in achieving soft tissue balance during total knee arthroplasty (TKA). Previous investigations have demonstrated the importance of various factors involved in obtaining flexion and extension gap balance, including the precision of femoral and tibial bone cuts as well as tensioning of the supporting pericapsular soft tissue structures (ligaments, capsule, etc.). However, the role of posterior compartment osteophytes has not been well studied. We hypothesize that space-occupying posterior structures affect soft tissue balance, especially in lesser degrees of flexion, in a cadaveric TKA model. Methods. Five cadaveric limbs were acquired. CT scans were obtained of each specimen to define the osseous contours. 3D printed specimen-specific synthetic osteophytes were fabricated in two sizes (10mm and 15mm). Posterior-stabilized TKAs were performed. Medial and lateral contact forces were measured during a passive range of motion using OrthoSensor ® (Dania Beach, FL) technology. For each specimen, trials were completed without osteophytes, and with 10mm and 15mm osteophytes applied to the posterior medial femur, with iterations at 0°, 10°, 30°, 45°, 60°, and 90° of flexion. These were recorded across each specimen in each condition for three trials. Tukey post hoc tests were used with a repeated measures ANOVA for statistical data analysis. Results. The presence of posterior medial osteophytes increased asymmetric loading from 0°– 45° of flexion. The 25–75% bounds of variability in the contact force was less than 3.5lbs. Conclusions. In this cadaveric TKA model, posterior femoral osteophytes caused an asymmetric increase in contact forces from full extension continuing into mid-flexion. To avoid unnecessary soft tissue releases, we recommend early removal of posterior femoral osteophytes prior to performing ligament releases to obtain desired soft tissue balance during TKA

Introduction. To achieve well aligned and balanced knee is essential for the post-operative outcome in total knee arthroplasty (TKA). Gap balancing technique can adjust the bone cut depending on the soft tissue balance in addition to soft tissue releases. Therefore, gap balancing technique would be more advantageous in soft tissue balance comparing to measured resection technique (MRT) in which soft tissue balancing relayed on soft tissue releases alone. Nevertheless, the influence of surgical technique on the post-operative knee stability has not been fully investigated. Objective. We introduced a new surgical technique (medial gap technique: MGT) according to modified gap technique regarding medial knee stability as important. The intra-operative soft tissue balance and post-operative knee stability were compared between MGT and MRT in posterior-stabilized (PS) TKA for varus type osteoarthritic knees. Materials & Methods. Sixty varus type osteoarthritis knees were involved in this study. PS type TKAs (NexGen LPS flexR) were performed using MGT in 30 knees (MGT group) and MRT in 30 knees (MRT group). The extension gap was made in the same manners in both groups. Both femoral and tibial bone cuts were perpendicular to the mechanical axis. Medial soft tissue releases were limited until the spacer block with the thickness corresponding to the resected lateral tibial condyle could be inserted. After extension gap was prepared, OFR-tensorR was used to assess soft tissue balance (center gap, varus angle) at extension and flexion prior to posterior femoral condyle bone resection. Both differences of the center gap and varus angle between at extension and flexion were calculated and used for size selection and external rotation angle of femoral component in MGT. The final joint component gaps were evaluated using OFR-tensorR with both femoral trial in place and patello-femoral joint reduced at 0, 10, 30, 45, 60, 90, 120 and 135 degrees of flexion. Quantitative stress radiographies were performed at 1 month, 6 months and 1 year post-operatively to assess joint stability. Joint opening distance (mm) at both medial and lateral joint compartment were measured with knee extension and flexion. Each parameter was compared between MGT and MRT group using unpaired t-test (p<0.05). Results. Pre-operative factors showed no significant differences between 2 groups. The joint component gaps were significantly larger in MRT group from 45 to 135 degrees of flexion (Fig.1). The joint opening at the lateral compartment was significantly larger than medial at both knee extension and flexion in both groups. The joint openings were significantly larger bilaterally in MRT group comparing to MGT group at both extension and flexion (Fig.2, 3). Discussions. Medial instability has been reported as a possible reason for the persistent knee pain after TKA in the varus knees. We proposed a new surgical technique (MGT) not to deteriorate medial stability and allow lateral looseness in TKA. Post-operative knee stability was superior in MGT group comparing to MRT group from one month to one year after surgery. The difference of the intra-operative soft tissue balance might play an important role on the post-operative knee stability

Introduction. Modified gap technique has been reported to be beneficial for the intraoperative soft tissue balancing in posterior-stabilized (PS) -TKA. We have found intraoperative ligament balance changed depending on joint distraction force, which might be controlled according to surgeons' fells. We have developed a new surgical concept named as “medial preserving gap technique (MPGT)” to preserve medial knee stability and provide quantitative surgical technique according to soft tissue balance measurement using a tensor device. The purpose of this study was to compare 3-years postoperative knee stability after PS-TKA in varus type osteoarthritic (OA) knees between MPGT and measured resection technique (MRT). Material & Method. The subjects were 94 patients underwent primary unilateral PS-TKA for varus type OA knees. The surgical technique was MPGT in 47 patients and MRT in 47 patients. An originally developed off-set type tensor device was used to evaluate intraoperative soft tissue balance. In MPGT, medial release was limited until the spacer block corresponding to the bone thickness from proximal lateral tibial plateau could be easily inserted. Femoral component size and external rotation angle were adjusted depending on the differences of center gaps and varus angles between extension and flexion before posterior femoral condylar resection. The knee stabilities at extension and flexion were assessed by stress radiographies at 1 and 3 years after TKA; varus-valgus stress test at extension and stress epicondylar view at flexion. We measured medial and lateral joint openings (MJO, LJO) at both knee extension and flexion. MJOs and LJOs at 2 time periods were compared in each group using paired t-test. Each joint opening distance was compared between 2 groups using unpaired t-test. The significance level was set as P < 0.05. Results. The mean extension MJOs at 1 and 3 years after TKA were 2.4, 2.6 mm in MPGT and 3.2, 3.1 mm in MRT respectively. The mean extension LJOs were 3.5, 3.5 mm in MPGT and 4.6, 4.5 mm in MRT. The mean flexion MJOs were 0.95, 0.77 mm in MPGT and 1.5, 1.2 mm in MRT, and the mean flexion LJOs were 2.2, 2.1 mm in MPGT and 3.0, 2.7 mm in MRT. MJOs were significantly smaller than LJOs in each group at 2 time periods. MJOs at extension and flexion, and LJOs at extension were significantly smaller in MPGT than MRT at 2 time periods. Discussion. Medial knee stabilities had been reported to be essential for postoperative clinical results. We reported medial compartment gap was more stable during mid-to-deep knee flexion in MPGT than MRT. MPGT provided the more stable intraoperative soft tissue balance than MRT in PS-TKA. MPGT was useful to preserve the higher medial knee stability than the lateral as well as MRT, and beneficial to enhance postoperative knee stabilities as long as 3-years after PS-TKA in varus OA knees. MPGT would be an objective and safer gap technique to enhance clinical outcomes

Both gap balancing and measured resection for TKA will work and these techniques are often combined in TKA. The only difference is really the workflow. The essential difference in gap balancing is that you determine femoral component rotation by cutting the distal femur and the proximal tibia, and then using a spacer to determine femoral rotation. I prefer measured resection because I am, for most cases, a cruciate retaining surgeon. It is not ideal to determine femoral rotation based upon a gap balancing if you retain the cruciate. It is also important to maintain the joint line, especially in cruciate retention, in order to reproduce more normal kinematics and balance the knee throughout the range of flexion and extension. It is my opinion that the soft tissue balancing is easier to do with measured resection and the workflow is easier. The sequence of cuts and soft tissue balance is different if one is a gap balancing surgeon. This is more conducive for people who are cruciate substituters, but more difficult in a varus cruciate retaining knee. In that situation, if you determine femoral rotation by gap balancing with the tibia before you have cleared the posterior medial osteophytes in the varus knee, and remove the last bit of meniscus, you could artificially over rotate the femoral component causing posteromedial laxity. The major difference is that cutting the posterior cruciate will open the flexion space and allow the surgeon easier access to the posteromedial corner of the knee before the posterior femoral cut is made. It is also important to remember that in most cases cruciate substitution surgeons will make the flexion space 2 mm smaller than the extension space to compensate for the flexion space opening when the posterior cruciate is cut. The extensor mechanism plays an important role in flexion balance and should only be tested once the patella is prepared and the patella is back in the trochlear groove. I prefer gap balancing in most revision knees as I am virtually always substituting for the posterior cruciate in that case. My technique for measured resection is to assess the character of the knee prior to surgery. Is it varus? Is it valgus? Does it hyperextend? Does it have a flexion contracture? Would the knee be considered tight or loose? I cut the distal femur first, based upon measured resection. I use anatomic landmarks to determine femoral rotation. My most consistent landmark is the transtrochlear line, which is not always from the top of the notch to the bottom of the trochlea. I will use the medial epicondyle and the posterior reference in a varus knee, but not in a valgus knee. The tibial cut, also by measured resection, is easier once the femur has been prepared. The patellar cut is also a measured resection. Having done a preliminary soft tissue balance based upon the deformity, I will then use trial components to finish the soft tissue balance. In summary, both techniques can be used successfully in a cruciate substituting knee, but measured resection, in my opinion, is preferable especially in varus arthritis when the posterior cruciate is retained

INTRODUCTION. There is a growing interest in surgical variables that are controlled by the orthopaedic surgeon, including lower leg alignment and soft tissue balancing. Since more tight control over these factors is associated with improved outcomes of total knee arthroplasty (TKA), several computer navigation systems have been developed. Many meta-analyses showed that mechanical axis accuracy and component positioning are improved using computer navigation and one may therefore expect better outcomes with computer navigation but studies showing this are lacking. Therefore, a systematic review with meta-analysis was performed on studies comparing functional outcomes of computer-navigated and conventional TKA. Goals of this study were to (I) assess outcomes of computer-navigated versus conventional TKA and (II) to stratify these results by the surgical variables the systems aim to control. METHODS. A systematic search in PubMed, Embase and Cochrane Library was performed for comparative studies reporting functional outcomes of computer-navigated versus conventional TKA. Knee Society Scores (KSS) Total were most often reported and studies reporting this outcome score were included. Outcomes of computer-navigated and conventional TKA were compared (I) in all studies and (II) stratified by navigation systems that only controlled for lower leg alignment or systems that controlled for lower leg alignment and soft tissue balancing. Level of evidence was determined using the adjusted Oxford Centre for Evidence-Based Medicine tool and methodological quality was assessed using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) tool. Outcomes were reported in mean difference (MD) with 95% confidence intervals [Lower Bound 95%, Upper Bound 95%]. RESULTS. Twenty-eight studies reported KSS Total outcomes in 3,504 patients undergoing computer-navigated or conventional TKA. Fifteen studies were evidence level I, five studies level II and eight studies level III. Study quality varied between low and high with most studies having high methodological quality. Patients reported better outcomes following computer navigated TKA than conventional TKA (MD 2.86 [0.96, 4.76], p=0.003), which was both seen at short-term follow-up of six months and one year (MD 5.20 [3.41, 7.00] and MD 8.46 [0.65, 16.28], respectively) and at mid-term follow-up (≥4 years) (MD 2.65 [0.96, 4.76]) (Figure 1). In studies that used computer navigation for controlling lower leg alignment, no difference in functional outcomes was seen between computer-navigated and conventional TKA (MD 0.66 [−2.06, 3.38], p=0.63, Figure 2). However, in studies that used computer navigation for controlling lower leg alignment and soft tissue balancing, patients reported superior functional outcomes following computer-navigate over conventional TKA (MD 4.84 [1.61, 8.07], p=0.003, Figure 3). CONCLUSION. This is the first meta-analysis showing superior functional outcomes following computer-navigated over conventional TKA. Stratifying results by variables the systems control, superiority in functional outcomes following computer-navigated over conventional TKA were only seen in systems that controlled soft tissue balancing. This suggests that soft tissue balancing plays an important role in short-term outcomes of TKA. Manually controlling all these surgical variables can be difficult for the orthopaedic surgeon and findings in this study suggest that computer navigation may help managing these multiple variables and improve outcomes. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

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

Most orthopaedic surgeons believe that total knee replacement has superb patient outcomes. Long-term results are excellent, with one study showing 15 year survivorship of 97%. However, our objective assessments of our patients' results are greater than patients' subjective assessments. In a study by Dickstein of total knee patients, one-third were not satisfied even though they were all thought to have had successful results by their orthopaedic surgeons. Noble and Conditt's study showed 14% of patients dissatisfied with their outcome with more than half expressing problems with routine activities of daily living. We are puzzled by this patient dissatisfaction since radiographs usually show normal component alignment and positioning. Perhaps some of these patients have subtle soft tissue imbalance and kinematic maltracking. Excellent aligned bone cuts can be expected with modern instrumentation, especially if patient specific cutting instruments or computer navigation are used. However, inadequate instrumentation exists for soft tissue balancing. It is usually based on feel and visual estimation. Soft tissue balancing techniques are difficult to teach and perform by a less experienced surgeon. Smart trials with load bearing and alignment sensors, which can be used with the medial retinaculum closed, will demonstrate the total knee kinematics and quantify soft tissue balance. Graduated soft tissue balancing can be performed while visualising changes in compartment loads. Studies are ongoing with smart trials to establish evidence-based clinical algorithms for soft tissue balancing and document the effects of these techniques on patient satisfaction and long-term outcome