Introduction. High flexion knee arthroplasties have been designed to allow up to 155 degrees flexion and enable high flexion activities such as kneeling and squatting. To date randomised controlled trials have shown no difference in range of movement (ROM) between high flexion and standard designs. Objectives. The aim of this study was to determine if there is a difference in functional outcome and ROM between the standard and high flexion design of the PFC Sigma TKA system. Methods. 84 patients with the diagnosis of osteoarthritis undergoing primary total knee arthroplasty were randomised to receive either a PFC Sigma or PFC Sigma RP-F total knee arthroplasty. ROM, Oxford Knee Score, Knee Society Score, Patella score and SF-12v2 were assessed independently before and at one year after surgery. Patients were blinded to the implant they received. Results. 42 patients in each group were included in this study and underwent surgery. 77 patients (92%) completed their one-year follow-up. There was no statistically significant difference in preoperative scores between groups. At one year there was a statistically significant difference in ROM between the groups with a mean of 105 degrees in the PFC Sigma and 114 degrees in the PFC Sigma RP-F group (p=0.01). There was also a statistically significant difference in flexion with 106 degrees and 115 degrees respectively (p=0.007). The difference in improvement in ROM and flexion was also statistically significant between the groups (p=0.009 and p=0.008). There was no statistically significant difference in any of the functional outcome scores. Conclusions. This is the first randomised controlled trial to show a statistically significant difference in ROM and flexion between a standard and a high flexion design TKA. Further follow-up will be carried out to determine if these differences persist over time and to evaluate the long-term survival of the different designs

The PFC Sigma Cobalt Chrome Sigma (PFCSCC) was introduced in 2006, an update of the PFC Sigma designed to reduce backside wear. To help identify any significant early failures following its introduction, we prospectively identified all recipients over a one-year period. The patient's clinical, demographic and radiographic data, American Knee Society scores (AKSS), Oxford Knee scores (OKS) and SF-12 scores was recorded pre-operatively and at one, three and five years. 233 patients underwent 249 primary knee arthroplasties with the PFCSCC. Seventeen patients (19 knees) died and 29 patients (30 knees) were also lost to follow up at the five year point. The mean age was 66.6 (34–80) with 47.6% of the cohort being male. The mean five year follow-up was 1836 days (1530–2307). Five knees (2.2%) were revised for infection and three were revised for pain. The 5–year cumulative survival rate was 96.6% for any failure and 98.6% for aseptic failure. AKSS 32.6 (0–86.6) preoperatively, 80.7 (29–95) 5 years P < 0.001. OKS was 39.0 (22–53) preoperatively, 23.5 (4.7–42.3) 5 years P < 0.001. These results demonstrate a good early survivorship when compared to the old design PFC Sigma, however further follow-up to ten years is required

The DuPuy Sigma total knee arthroplasty (TKA) is a modification of the well-established Press Fit Condylar (PFC) TKA and is used extensively in the UK and worldwide. This study reports the first 10-year clinical and radiological follow-up data for the Sigma PFC. A total of 235 consecutive Sigma TKAs were performed in 203 patients between October 1998 and October 1999, in our unit. Patients were seen at a specialist nurse-led clinic 1 week before admission and at 6 months, 18 months, 3 years, 5 years and 7-10 years after surgery. Data was recorded prospectively at each clinic visit. Of 235 knees, 171 (147 patients) were alive at 10 years. Twelve were lost to follow up. Eight knees (3.4%) were revised; four for infection and four underwent isolated change of polyethylene insert. Ten-year survival with an end point of revision for any reason was 95.9%, and with an endpoint of revision for aseptic failure was 98.7%. The mean American Knee Society score was 62 at 8-10 years compared with 31 out of 100 pre-operatively. Our results show that the PFC Sigma knee arthroplasty performs well over the first 10 years post-implantation

We set out to demonstrate the 10-year survivorship of the PFC sigma TKA in a young patient group. Demographic and clinical outcome data were collected prospectively at 6 months, 18 months, 3 years, 5 years and 8–10 years post surgery. The data were analysed using Kaplan Meier survival statistics with end point being regarded as death or revision for any reason. 203 patients were found to be < 55 years at the time of surgery. Four patients required revision and four patients died. Another four patients moved away from the region and were excluded from the study. A total of 224 knees in 199 patients (101 male and 98 females.) 168 patients had a diagnosis of Osteoarthritis and 28 with inflammatory arthritis. Average age 50.6 years range 28–55 years (median 51). Ten-year survivorship in terms of revision 98.2% at ten years 95% confidence interval. Our results demonstrate that the PFC Sigma knee has an excellent survival rate in young patients over the first 10 years. TKR should not be withheld from patients on the basis of age

Background. Although the wear of conventional polyethylene liner becomes a serious problem in a long term follow up after total knee arthroplasty, there are few reports of measuring the polyethylene wear. Questions/purposes. Is it possible to measure the linear wear rates in the non-cross-linked polyethylene liner used in the Press Fit Condylar (PFC) Sigma total knee system? Does the polyethylene wear influence on the clinical results?. Patients and Methods. The senior author and his colleagues performed total knee arthroplasties using the PFC knee system between 1997 and 2009. A follow-up was performed at minimum of 6 years after surgery, and 113 knee replacements (Female: 59 including 93 knee replacements, Male: 16 including 20 knee replacements) were clinically assessed and examined using X-ray imaging. An X-ray table was useful to make the X-ray accurately enter the tibial component at a parallel angle for anteroposterior image of radiograph when measuring the wear on knee prosthesis (Fig.1). The average follow-up period was 11.5 ± 3.4 years (range: 6.0–17.0) postoperatively. Results. There was no loosening found in the knee prostheses. However, revision surgery was performed for a case with consistent varus instability. The wear rate in the polyethylene liner was an average of 0.08 ± 0.07 (range, 0.01–0.26) mm/year on the medial joint and 0.04 ± 0.03 (range, 0.0–0.11) mm/year on the lateral joint with significant difference. The X-ray imaging was useful to measure the wear accurately. Conclusion. The medium-to-long term clinical results of the PFC Sigma Design total knee system with minor changes added have been good thus far for almost 20 years. The wear rate in the non-cross-linked polyethylene liner was very low. In the future, the extra long-term results will need to be researched further. <Figure Legend>. Fig. 1 Measurement of polyethylene wear of the prosthetic knee joint. All measurements on the radiographs of the two-dimensional position of the polyethylene liner were performed by a single researcher with use of a computerized measurement system which had a computerized digitizer with an accuracy of ± 0.01 mm. Only the anteroposterior radiographs of the knee joint were used for the measurements. The thickness of polyethylene liner was measured in both the lateral (a) and medial (b) parts of the liner in each radiograph with correction of magnification by known tibial component medial-lateral diameter (c). The polyethylene wear rate was determined by comparing the thickness in the follow-up radiograph with the thickness in the initial three-week postoperative radiograph at the same locations. The thickness of the polyethylene was measured at its shortest distance in the same flexion angle of the knee joints. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Total Knee Arthroplasty (TKA) is an effective surgery performed for knee osteoarthritis. Despite this success up to 20% of patients are less than fully satisfied. Rotating platform (RP) bearings have demonstrated significant reduction in rates of wear in laboratory studies but thus far have failed to demonstrate a clinical difference compared to fixed bearing (FB) arthroplasty in patients. This may be due to studies limited by small sample size and single centre design. Additionally, no studies have utilised modern patient-reported outcome measures (PROMs) such as PKIP to investigate differences between these bearings. A non-randomised, prospective, multi-centre study was conducted across centres in Australia, United Kingdom and the United States from November 2012 to May 2015. Knee prosthesis included were the RP and FB models of the PFC Sigma Knee (Depuy, Synthes) and the ATTUNE Knee (Depuy, Synthes). Data was collected on pre-arthroplasty interventions, demographics and PROMs. PROMs included were the KOOS, OKS, EQ53DL and PKIP. Participants were followed-up for 2 years. A total of 1,718 patients were recruited across 27 centres. 959 participants underwent a FB TKA, 759 participants underwent a RP TKA. No significant difference was found between RP and FB in change from baseline at 2 years across any parameter in all PROMs investigated at 2 years. Body Mass Index pre-operatively was the biggest indicator of change from baseline at 2 years. Our data demonstrates similar improvements in the short-term in both RP and TKA across all PROMs. Patients reported similar scores in satisfaction, confidence, mobility and stability in the PKIP PROM for both RP and FB groups. We have not found any evidence to suggest that RP TKA is disadvantageous at 2 years, and this is reassuring for any surgeon looking to utilise this bearing type in practice. Our data does not demonstrate a clinical advantage in RP TKA over FB TKA at 2 years in any PROM

Introduction:. Backside wear has been previously reported through in-vitro and in-vivo to have a significant contribution to the total wear in rotating bearing TKRs. The present study investigated the contribution of backside wear to the total wear in the PFC Sigma rotating platform mobile bearing TKR. In addition, the wear results were compared to the computed wear rates of the PFC Sigma fixed bearing TKR, with two different bearing materials. Materials and Methods:. The commercially available PFC Sigma rotating platform mobile bearing and PFC Sigma fixed bearing total knee replacements, size 3 (DePuy, UK) were tested, with either conventional or moderately cross-linked (5 MRad) GUR1020 UHMWPE bearing materials. The computational wear model for the knee implants was based on the contact area and an independent experimentally determined non-dimensional wear coefficient [1,2,3]. The experimental wear test for the mobile bearing was force controlled using the ISO anterior-posterior force (ISO14243-1-2009). However, due to time limitation of the explicit simulation required to run the force controlled model, the simulation was run using the AP displacements taken from the experimental knee simulator which was run under the ISO AP force. The Sigma fixed bearing TKR was run under high level of anterior-posterior displacements (maximum of 10 mm). Results and Discussion:. The rotating platform bearing showed lower wear rates, compared to that of the PFC Sigma fixed bearing, for both conventional and moderately cross-linked UHMWPE bearing materials (Fig. 1). Moreover, the results showed a high contribution of backside wear to the total wear, approximately 1 mm. 3. /million cycles (∼30% of the total wear). The computational wear predictions were in good agreements with the clinical and experimental measurements [4,5]. Contrasting the effect of bearing material on wear prediction, introducing the moderately cross-linked UHMWPE as a bearing material reduced the predicted wear rates by approximately 1 mm. 3. /million cycles in rotating platform bearing, compared to more than 5 mm. 3. /million cycles in PFC fixed bearing TKR. This reduced effect of cross-linking on wear in mobile bearing was mainly attributed to the lower cross-shear ratios in these bearings, compared to fixed bearings, and the less dependency of wear in moderately cross-linked UHMWPE on the degree of cross-shear, compared to conventional UHMWPE. Decreasing the degree of cross-shear from higher values (Sigma curved insert, high kinematic) to lower ones (rotating platform bearing) changed the predicted wear rates from 8.7 to 3.3 and from 3.4 to 2.4 (mm. 3. /million cycles), for conventional and moderately cross-linked UHMWPE materials respectively (Fig. 2). Conclusion:. The modelling confirmed the previous experimental observations of very low wear with the rotating platform knee. The models also determined the level of wear from the backside of the rotating platform knee which was approximately 1 mm. 3. /million cycles. The fixed bearing knee with moderately cross linked polyethylene also showed low wear at approximately 3 mm. 3. /million cycles. These low wear rates were determined under high kinematic walking cycles conditions. Future work will consider additional conditions

Introduction. For many patients, total knee replacement (TKR) provides pain relief and restores motion for many years [1]. Some patients, however, experience early failures and require revision surgery. One of the suggested contributors to early failure has been excessive wear due to malalignment [2]. Previous work has shown that varus-valgus malalignment results in extreme condylar loading and could lead to high wear [3]. The purpose of this experiment, therefore, was to evaluate medial/lateral load sharing in an in vitro wear simulation. Methods. Wear testing was conducted on midsized Attune and Sigma fixed bearing cruciate substituting TKR components (DePuy Synthes). The two systems differ in many aspects; notably, Attune employs antioxidant-stabilized moderately-crosslinked polyethylene and a gradually changing sagittal femoral curvature while Sigma uses remelted moderately-crosslinked polyethylene and a mulit-radius femoral design. Wear was evaluated across a wide range of medial/lateral (M/L) load splits: 10/90, 60/40, and 90/10 using an AMTI six-station knee simulator (Figure 1). Simulation was conducted for 3 million cycles using at 1 Hz using previously described methods [4] with ‘High Kinematic’ displacement controlled inputs in 25% bovine calf serum (Hyclone) at 37 ± 2°C supplemented with sodium azide and EDTA. Polyethylene wear was determined gravimetrically with load soak compensation every 0.5 Mcyc. Results. The wear of Attune and Sigma components were consistently low across all load splits (Figure 2). The standard 60/40 load split was the lowest wearing condition for both designs, but the extreme lateralized and medialized loadings were not appreciably higher (Figure 3). No statistics are available due to the small sample size. Conclusion. The medial/lateral load sharing did not affect wear for Attune and Sigma designs in this displacement controlled in vitro wear simulation. For each group, the inserts subjected to extreme load splits wore comparably to those with a standard 60/40 load split. It is important to note that all samples experienced similar motions with similar cross-shear and differed primarily in the condylar load sharing. With this in mind, the relationship of the results is supported by research in fundamental polyethylene behavior that suggests cross-shear may dominate loading effects [5]. Clinically, however, patients will likely experience altered motions and other effects due to malalignment that were not investigated in this study. While this study showed limited variation in wear across a wide range of condylar load ratios, surgeons and device manufacturers should continue to explore the full implications of malalignment

Introduction. Aseptic loosening of total knee replacements is a leading cause for revision. It is known that micromotion has an influence on the loosening of cemented implants though it is not yet well understood what the effect of repeated physiological loading has on the micromotion between implants and cement mantle. This study aims to investigate effect of physiological loading on the stability of tibial implants previously subjected to simulated intra-operative lipid/marrow infiltration. Methods. Three commercially available fixed bearing tibial implant designs were investigated in this study: ATTUNE. ®. , PFC SIGMA. ®. CoCr, ATTUNE. ®. S+. The implant designs were first prepared using a LMI implantation process. Following the method described by Maag et al tibial implants were cemented in a bone analog with 2 mL of bone marrow in the distal cavity and an additional reservoir of lipid adjacent to the posterior edge of the implant. The samples were subjected to intra- operative range of motion (ROM)/stability evaluation using an AMTI VIVO simulator, then a hyperextension activity until 15 minutes of cement cure time, and finally 3 additional ROM/stability evaluations were performed. Implant specific physiological loading was determined using telemetric tibial implant data from Orthoload and applying it to a validated FE lower limb model developed by the University of Denver. Two high demand activities were selected for the loading section of this study: step down (SD) and deep knee bend (DKB). Using the above model, 6 degree of freedom kinetics and kinematics for each activity was determined for each posterior stabilized implant design. Prior to loading, the 3-D motion between tibial implant and bone analog (micromotion) was measured using an ARAMIS Digital Image Correlation (DIC) system. Measurement was taken during the simulated DKB at 0.25Hz using an AMTI VIVO simulator while the DIC system captured images at a frame rate of 10Hz. The GOM software calculated the distance between reference point markers applied to the posterior implant and foam bone. A Matlab program calculated maximum micromotion within each DKB cycle and averaged that value across five cycles. The implant specific loading parameters were then applied to the three tibial implant designs. Using an AMTI VIVO simulator each sample was subjected to 50,000 DKB and 120,000 SD cycles at 0.8Hz in series; equating to approximately 2 years of physiological activity. Following loading, micromotion was measured using the same method as above. Results. Initial micomotion measurements during DKB activity for ATTUNE. ®. , PFC SIGMA. ®. CoCr, ATTUNE. ®. S+ were 155µm, 246µm, and 104µm, respectively, and following physiological loading were 159µm, 264µm, and 112µm, respectively. While there was statistical significance between the micromotion of implant designs (p<0.05), there was no significance between before and after loading. Conclusion. This study shows there is no significant change in micromotion after approximately 2 years of physiological loading. However, there is a significant difference in micromotion between implant designs

Introduction. Wear of polyethylene continues to be a significant factor in the longevity of total knee replacement (TKR). Moderately cross-linked polyethylene has been employed to reduce the wear of knee prostheses, and more recently anti-oxidants have been introduced to improve the long-term stability of the polyethylene material. This is the initial study of the wear of a new anti-oxidant polyethylene and a new TKR design, which has modified femoral condylar geometry. Materials and Methods. The wear of a new TKR the Attune knee was investigated using a physiological six station Prosim knee wear simulator (Simulator Solutions, UK). Six mid-size Attune fixed bearing cruciate retaining TKRs (DePuy Inc, Warsaw, USA) were tested for a period of 6 million cycles. The inserts were manufactured from AOX™, a compression moulded GUR1020 polyethylene incorporating Covernox™ solid anti-oxidant. The AOX polymer was irradiated to 8M Rad, to give a moderately cross-linked material. High and intermediate kinematics, under anterior-posterior displacement control were used for this study (McEwen et al 2005). The maximum femoral axial loading was 2600N, with flexion-extension of 0 to 58°, an anterior-posterior displacement of 0–10 mm for high kinematics and 0–5 mm for intermediate, and an internal-external rotation of ±5°. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (v/v) sodium azide solution in deionised water, as an antibacterial agent, and was changed approximately every 0.33 Mc. Wear was assessed gravimetrically and moisture uptake was assessed using unloaded soak controls. Volumetric wear was calculated using a density of 0.94 mg/mm. 3. , and compared with a previous study examining the Sigma XLK TKR design which uses moderately crosslinked polyethylene which is in current clinical use (Brockett et al 2012). Results. The mean wear as a function of cycles, under high and intermediate kinematics is indicated in Figure 1. There was a significant reduction in wear rate with intermediate kinematics. The mean wear rate for the Attune TKR under high kinematics (0–3 Mc) was 6.27±1.03 mm. 3. /Mc, and during the intermediate kinematics (3–6 Mc) was 4.63 ±1.01 mm. 3. /Mc. These wear rates were comparable to previously reported data for a moderately cross-linked UHMWPE Sigma TKR (Figure 2, Brockett et al 2012) under high kinematics. Under intermediate kinematics there was a small but significant difference between the wear rates (ANOVA, p<0.05). Discussion. A new Attune design TKR has a new bearing material and a new femoral geometry was examined through experimental wear simulator studies, and compared with a previously reported study conducted under the same test conditions. The wear performance of the new Attune TKR was comparable with the Sigma XLK bearing under high kinematics, but higher under intermediate kinematics. This study has examined the short term wear performance of the implant, and found it to be a low wear option for TKR. The longer-term potential advantages offered by a more oxidatively stable material will be investigated in the future

Introduction. Patella femoral joint bearings in total knee replacements have shown low wear (3.1 mm. 3. /MC) under standard gait simulator conditions. 1. However, the wear in retrieval studies have shown large variations between 1.3 to 45.2 mm. 3. /year. 2. Previous in vitro studies on the tibial femoral joint have shown wear is dependent on design, materials and kinematics. 3. . The aim of this study was to investigate the influence of the design (geometry) and shape on the wear rate of patella femoral joints in total knee replacements. Materials and Methods. The Leeds/Prosim knee simulator was used to investigate the wear of two types of commercially available patellae. The PFC Sigma cobalt chrome femoral component was coupled with 2 types of patellae buttons: round and oval dome. The UHMWPE was the same for the both types – GUR1020 GVF (gamma irradiated in vacuum and foiled packed). 25% bovine serum was used as the lubricant. The test were carried out at three conditions – high medial lateral (ML) rotations (<4°) and uncontrolled ML displacement (<4 mm), low ML rotation (<1°) and uncontrolled ML displacement (<4 mm); the physiological gait cycle; and low ML rotation and controlled ML displacement (<1.5 mm). In this abstract the two designs were tested in physiological gait condition (Figure 1). Patella ML displacement and tilt were passively controlled and measured after every 300,000 cycles. A ligament resisting force equivalent to 10 N4 was applied on the lateral side of the patella to avoid patella slip. Five samples of each design were tested for 3 million cycles at a cycle rate of 1 Hz. The wear volume was obtained gravimetrically every million cycles and presented with 95% confidence limits. Statistical significance was taken at p<0.05. Results and Discussions. The wear rate of PFC sigma round dome patella was higher (8.63 ± 3.44 mm. 3. /million cycles) compared to the PFC sigma oval dome patella (6.28 ± 3.89 mm. 3. /million cycles) (Figure 2). However, no significant difference in the wear rates was found between the two shapes (P=0.2). The low area of contact of oval dome patella (31.2% of total surface area) as compared to round dome patella (39.9%) led to low wear. 5. . The wear volume and the patellar tilt were positively correlated for oval dome and round dome patella, R. 2. > 0.9 (Figure 3). Increase in the patellar tilt resulted increase in sliding distance in perpendicular direction of polymer orientation. This led to higher wear volume. Conclusions. Wear rate decreased with change of patella shape from round dome to oval dome although not significantly. Increase in the patellar tilt resulted in increase in the wear volume. Acknowledgement. This research was supported in part by the DePuy and EPSRC. In addition, it was partially funded through WELMEC, a Centre of Excellence in Medical Engineering funded by the Wellcome Trust, under grant number WT 088908/Z/09/Z and additionally supported by the NIHR (National Institute for Health Research) as part of collaboration with the LMBRU (Leeds Musculoskeletal Biomedical Research Unit)

Introduction. Tibiofemoral constraint in patients with total knee replacements (TKR) is dependent on both implant geometry and the surrounding soft tissue structures. Choosing more highly constrained geometries can reduce the contribution of soft tissue necessary to maintain joint stability [1]. Often when knee revision surgeries are required, the soft tissue and bone are compromised leading to the use of more constrained implants to ensure knee stability [2]. The current study quantifies the differences in varus-valgus (VV) and internal-external (IE) constraint between two types of total knee revision systems: SIGMA® TC3© and ATTUNE® REVISION. Methods. Nine cadaveric knees (7 male, age 64.0 ± 9.8 years, BMI 26.28 ± 4.92) were implanted with both fixed-bearing SIGMA TC3 and ATTUNE REVISION knee systems. Five knees received the TC3 implant first, while the remaining 4 received the ATTUNE implant first. The knees were mounted in an inverted position, and a six degree-of-freedom force-torque sensor (JR3, Woodland, CA) was rigidly secured to the distal tibia (Fig. 1). A series of manual manipulations applying IE and VV torques was performed through the flexion range [3]. Each specimen was then revised to the alternate revision system, and the manual manipulations were repeated. Joint loads were calculated, and tibiofemoral kinematics were described according to the Grood-Suntay definition [4]. VV and IE kinematics were calculated as a function of flexion angle, VV torque, and IE torque as has been described previously [3]. The knees were analysed at ±6 Nm VV and ±4 Nm IE, and the kinematics were normalized to the zero load path. A paired t-test (p < .05) was employed to identify significant differences between the kinematics of the two knee systems at 10º flexion increments. Results. Less VV motion was observed in the ATTUNE REVISION system compared to the TC3 system reaching statistical significance in mid-flexion. (Fig. 2). No significant differences were observed in IE rotation between the two designs, except in full extension where the SIGMA TC3 provided increased constraint (Fig. 3). Discussion. The ATTUNE REVISION System provided increased VV constraint compared to the TC3 design. The ATTUNE tibial post was more conforming to the femoral box throughout flexion, which contributed to the increased constraint. However, this increase was not concurrent with a reduction in IE rotational freedom as has been common with more constrained revision systems [5]. ATTUNE REVISION provides additional VV stability while retaining knee IE freedom and, therefore, may enable more natural knee kinematics for patients with MCL deficiency in need of a revision TKR. Future work will focus on how the increased levels of VV constraint affect weight-bearing knee kinematics in the presence of ligament deficiency. Acknowledgements. This work was supported by DePuy Synthes Joint Reconstruction, Warsaw, Indiana, a Johnson and Johnson Company. For figures and references – please contact authors directly

Objective. In this study, we aim to compare total bone amount extracted in total knee arthroplasty in implant design and the bone amount extracted through intercondylar femoral notch cut. Material and Method. In this study, we implemented 10 implants on a total of 50 sawbones from 5 different total knee arthroplasty implant brands namely Nex-Gen Legacy (Zimmer, Warsaw, IN, USA), Genesis 2 PS (Smith&Nephew, Memphis, TN, USA), Vanguard (Biomet Orthopedics Inc., Warsaw, IN, USA), Sigma PS (De Puy, Johnson&Johnson, Warsaw, IN, USA), Scorpio NRG PS (Stryker Co., Kalamazoo, USA). Equal or the closest sizes of each brand on anteroposterior plane were selected, and cuts were made following standard technique(see Fig 1 and 2). Extracted bone pieces were measured in terms of volume and length on three planes, and statistically analysed. The volume of all pieces available after each femoral incision was measured according to Archimedes’ principles. Furthermore, the volume of each intercondylar femoral notch pieces was measured separately from other pieces but with the same method. The measurement of intercondylar femoral notch pieces on 3 planes (medial-lateral, anterior-posterior, superior-inferior) was made using Kanon slide gauge (Ermak Ltd, Istanbul, TR). Femoral notch incision pieces were scanned with CAD/CAM technology using three-dimensional scanner 1 SeriesTM (Dental Wings Inc, Montreal, QC, Canada), and the measurements were confirmed with DWOS CAD 4.0.1 software (Dental Wings Inc, Montreal, QC, Canada)(see figure 3a-e). The volume of 10 intercondylar femoral notch pieces performed through the set of each brand was averaged, and considered as the incision volume of that particular brand. Results. The comparison made by excluding femoral notch cuts did not produce any statistically significant difference between the amounts of bone extracted. The least volumetric value measured in extracted intercondylar femoral notch cut was obtained using Vanguard (3,6±0,4 cm3). The gradually increasing volumes were obtained from Nex-Gen (3,7±0,5 cm3), Sigma (5,7±0,4 cm3), Genesis 2 (6,3±0,3 cm3) and Scorpio NRG (6,7±0,7 cm3), respectively. There was no statistical difference between Genesis 2 and Scorpio NRG, and between Nex-Gen and Vanguard. Conclusion. There are significant differences among implant designs in terms of preserving bone stock, and much of these differences stems from intercondylar femoral notch incision

Introduction. Persistent patellofemoral (PF) pain is a common postoperative complication after total knee arthroplasty (TKA). In the USA, patella resurfacing is conducted in more than 80% of primary TKAs [1], and is, therefore, an important factor during surgery. Studies have revealed that the position of the patellar component is still controversially discussed [2–4]. However, only a limited number of studies address the biomechanical impact of patellar component malalignment on PF dynamics [2]. Hence, the purpose of our present study was to analyze the effect of patellar component positioning on PF dynamics by means of musculoskeletal multibody simulation in which a detailed knee joint model resembled the loading of an unconstrained cruciate-retaining (CR) total knee replacement (TKR) with dome patella button. Material and Methods. Our musculoskeletal multibody model simulation of a dynamic squat motion bases on the SimTK data set (male, 88 years, 66.7 kg) [5] and was implemented in the multibody dynamics software SIMPACK (V9.7, Dassault Systèmes Deutschland GmbH, Gilching, Germany). The model served as a reference for our parameter analyses on the impact on the patellar surfacing, as it resembles an unconstrained CR-TKR (P.F.C. Sigma, DePuy Synthes, Warsaw, IN) while offering the opportunity for experimental validation on the basis of instrumented implant components [5]. Relevant ligaments and muscle structures were considered within the model. Muscle forces were calculated using a variant of the computed muscle control algorithm. PF and tibiofemoral (TF) joints were modeled with six degrees of freedom by implementing a polygon-contact model, enabling roll-glide kinematics. Relative to the reference model, we analyzed six patellar component alignments: superior-inferior position, mediolateral position, patella spin, patella tilt, flexion-extension and thickness. The effect of each configuration was evaluated by taking the root-mean-square error (RMSE) of the PF contact force, patellar shift and patellar tilt with respect to the reference model along knee flexion angle. Results. The analysis showed that the PF contact force was mostly affected by patellar component thickness (RMSE=440 N) as well as superior-inferior (RMSE=199 N), and mediolateral (RMSE=98 N) positioning.. PF kinematics was mostly affected by mediolateral positioning, patellar component thickness, and superior-inferior positioning. Medialization of the patellar component reduced the peak PF contact force and caused a lateral patellar shift. Discussion. Based on our findings, we conclude that malalignment in mediolateral and superior-inferior direction, tilt and thickness of patellar resurfacing are the most important intraoperative parameters to affect PF dynamics. It could be shown that the translational positioning is more critical than rotational positioning regarding PF contact force. Reported findings are in good agreement with previous experimental and clinical studies [2–4]. Our data reveal that patellar component positioning has to be aligned precisely during total knee arthroplasty to prevent postoperative complications. For any figures or tables, please contact authors directly

Aim. The aim of the study was to assess the impact of a self aligning unidirectional mobile tibial bearing and the use of a patella button on lateral patella release rates within a knee system using a common femoral component for both the fixed and mobile variants. Methods and results. A total of 347 patients undergoing TKR were included in the study and randomly allocated to receive either a Mobile Bearing (171 knees) or a Fixed Bearing (176 knees) PS PFC Sigma TKR. Further sub-randomisation into patella resurfacing or retention was performed for both designs. The need for lateral patella release was assessed during surgery using the ‘no thumbs’ technique. The lateral release rate was similar for fixed bearing (9.65%) and mobile bearing (9.94%) implants (p=0.963). Patella resurfacing resulted in lower lateral release rates when compared to patella retention (5.8% vs 13.8%; p=0.0131). This difference was most marked in the mobile bearing group where the lateral release rate was 16.3% with patella retention compared to 3.5% with patella resurfacing (p=0.005). Conclusion. The addition of a rotating platform tibial component had no impact on the lateral release rate in this study. Optimising patella geometry by patella resurfacing appears more important than tibial bearing deisgn per se. The combination of a mobile bearing design and patella resurfacing appears to optimise the lateral release rate and patello-femoral tracking in the PS PFC Sigma design which has a deeply radiused trochlea on the femoral component. The results with a patella resurfacing confirm the results with this prosthesis reported by Pagnano et al in Clin Orthop 428 pp221-227

Different femoral designs in TKA have shown multiple effects on the conformity of the patella-femoral joint. Historically, this anatomical relationship may interfere with clinical results. The objective of this study was to compare the reproducibility of a correct patello-femoral conformity in patients underwent TKA utilizing modern femoral implants. MATERIALS AND METHODS. We performed 50 consecutives TKA in fifty patients affected by knee arthritis utilizing the PFC Sigma System (De Puy, Warsaw, USA) with a new femoral design, having a prolonged anterior flange and a “smoother” throclea. The surgical procedure was performed utilizing the Sigma HP instrumentation to allow 3 degrees of external rotation of the femoral component and the “balanced gaps technique” was chosen. All patellae were replaced. All patients were evaluated preoperatively and at six months follow-up both clinically with the Knee society Score as well as radiografically: standing 30x90 cm. view, Merchant view, standard lateral view and a CT-scan with two millimeters cuts (Berger Protocol) at 20 degrees of flexion were all done. Particular attention was paid to the following CT measurements: patellar tilt, patellar conformity angle, patellar lateralization, femoral component external-rotation in relation to the patellar sitting. Statistical analysis was performed utilizing the t-test e the Wilcoxon test (p<.05). RESULTS. Any patient was dropped from the study group. Femoral component positioning in relationship to the trans-epicondilar axis showed at follow-up an external rotation of 2.74° (± 2.10°) respect to a preoperative value of 5.7 ° (± 1.80°). Average patellar conformity angle was at follow-up 12.5 (range, -2.5 ° - 28.2 °) respect to an average preoperative value of 10.3° (range, 1.5 – 25.6). Average patellar tilt at follow-up was 2.8°(±7.5°) respect to a preoperative average value of 18.5° (±8.5 °). Average lateralization index was at follow-up 2.7 mm (range, - 3.4 – 7.1 mm) respect to a preoperative value of 12.2 mm (± 4.8 mm). CONCLUSION. This study highlighted that a correct utilization of a modern instrumentation and a femoral design with softer edges and a prolonged femoral groove allow for a correct reproducibility of the patello-femoral conformity. TC scan is a reliable method to evaluate the patella-femoral compartment after TKA

Object. Although single-radius designs have theoretical advantages in some aspects, there has been a paucity of evaluation studies. The purpose of this study was to compare 10-year clinical, radiological, survivorship outcomes of single radius and multi radius posterior stabilized prosthesis in total knee arthroplasty(TKA) with Rheumatoid Arthritis (RA). Method. In this retrospective observational study, we reviewed 240 patients (240 knees) with RA who underwent TKA between Oct 2005 and Dec 2007: SR group (120 patients, 120 knees, Stryker Scorpio NRG) and MR group (120 patients, 120 knees, Depuy sigma RP). A 1 : 1 matched case control study was conducted in two groups which were similar in terms of age, gender, BMI, ASA classification and operation team. Mean follow-up periods were 10.73±1.13 (range: 8–13) years and 10.82±1.09 (range: 7–13) years. Results. In SR group, the mean HSS score improved significantly from 38.63±8.76 to 87.67±6.62, the mean VAS score decreased significantly from 7.37±0.24 to 0.45±0.12. the mean range of motion improved significantly from 105.52°±7.78°to 124.32°±8.12° (p<0.001). In MR group, the mean HSS score improved significantly from 38.75±8.34 to 89.29±5.21, the mean VAS score decreased significantly from 7.62±0.26 to 0.33±0.10. the mean range of motion improved significantly from 104.18°±7.62° to 122.52°±8.03°(p<0.001). (See Figure 1) Clinical and functional improvements had no significant differences between the two groups. 6 complications were noted in SR group, including 2 cases of prosthetic loosening, 1 case of periprosthetic osteolysis, 3 cases of periprosthetic bright lines.6 complications were noted in MR group, including 2 cases of prosthetic loosening and 4 cases of periprosthetic bright lines. No case of infection was observed in two groups. Survivorship using Kaplan-Meier survival analysis was 97.5% (95% confidence interval [CI]: 96.8–98.3%) for the SR at 10 years and 98.3% (95% CI: 97.3–99.5%) for the MR group at 10 years, with no significant difference (p=0.755). (See Figure 2). Conclusion. This study suggested that both single-radius and multi-radius posterior stabilized prostheses can lead to satisfactory outcomes for clinical function, radiological evaluation and survivorship among RA patients undergoing TKA, and no significantly clinical differences was shown in two types of prostheses

Purpose. Prospective randomized intervention trial to determine whether patients undergoing rotating platform total knee arthroplasty have better clinical outcomes at two years when compared to patients receiving fixed bearing total knee arthroplasty as measured by the WOMAC, SF-36 and Knee Society (KSS) scores. Method. 67 consecutive patients (33 males and 34 females; average age 66 years) were randomized into either receiving a DePuy Sigma rotating platform (RP) total knee arthroplasty (29 patients) or a DePuy Sigma fixed bearing (FB) total knee arthroplasty (38 patients). Inclusion criteria included patients between the ages of 45–75 undergoing single-sided total knee arthoplasty for clinically significant osteoarthritic degeneration. Pain, disability and well-being were assessed using the WOMAC, KSS, and SF-36 preoperatively and at 6 months, 1 year and 2 years post-operatively. In addition, intraoperative measures were collected. Pre-operative radiographs were analyzed using the Kellgren and Lawrence Score, modified Scotts Scoring and mechanical axis. Post-operative radiographs were collected at 1 and 2 years and analyzed to identify evidence of prosthetic loosening, implant positioning and limb alignment. Results. The two groups were well-matched following randomization (age, BMI, side) and had no significant differences in intraoperative measures (operative time, estimated blood loss). There were no differences in the groups with respect to their preoperative radiographs. The average female patient was younger compared to their male cohorts (mean female = 63; mean male 68 p=0.005). The post-operative radiographs did not reveal any differences between RP and FB groups when comparing sagittal alignment of femoral and tibial components, patellar tilt and patellar location. With respect to clinical outcomes, both groups reported statistically significant improvements in KSS, WOMAC and SF-36 scores. There were no differences in their pre- and post-operative SF-36 mental component scores. The 1 year WOMAC function score was significantly higher (worse outcome) in the FB group (mean = 18) compared to the RP group (mean 7.8) (p < 0.01). Two year KSS scores were significantly higher (better outcome) in the FB group (mean = 95.7) compared to the RP group (mean = 85.9) (p < 0.05). Conclusion. Both rotating platform and fixed bearing total knee arthroplasty result in clinical improvement over pre-operative function, but has no effect on the mental component of the SF-36. The current study suggests that there is not a clear benefit in selecting either a rotating platform or a fixed bearing total knee system; rather both implants result in improved function. Interestingly, when comparing the results of the WOMAC and KSS, although both measure functional outcomes, when applied to the same population demonstrate differing sensitivity

Introduction. Cementless tibial fixation has been used for over 30 years. There are several potential advantages including preservation of bone stock and ease of revision. More importantly, for young active patients there is the potential for increased longevity of fixation. However, the clinical results have been variable, with reports of extensive radiolucent lines, rapid early migration and aseptic loosening. Problems appear to stem from a failure to become sufficiently osseointegrated, which in turn suggests a lack of primary stability. In order to achieve boney ingrowth, interface micromotions should be less than 50 microns, whereas fibrous tissue formation is known to occur if micrmotions are in excess of 150 microns. The degree of micromotion at the bone-implant interface are dependent on the kinematics and kinetics of the replaced joint. Finite element analyses has been used to assess primary stability, however, it is becoming increasing difficult to differentiate performance. The aim of this study was too examine the micromotion for a variety of different activities for three commercially available tibial tray designs. Methods. A finite element model of the implanted proximal tibia was generated form CT scans of a 72 year old male and material properties were assigned based on the Hounsfield units. Three tray designs were evaluated: LCS, Duofix and Sigma (DePuy Inc, Warsaw USA). The implants were assumed to be debonded, with a coefficient of friction of 0.4 applied to the bone-implant interface except for the porous coated region of the Duofix design, which was assumed to be 0.6. The distal portion the tibia was rigidly constrained. Five activities were simulated based on data from Orthoload.com (patient K1L) including walking, stair ascent, stair descent, sitting down and a deep knee bend. The three force and three moment time histories were discritised to give between 44 and 48 individual load steps. Custom written scripts were used to generate composite peak micromotion plots, which report the peak micromotion that occurs at each point of the contact surface during the gait cycle. The primary stability was then assessed by reporting the maximum micromotion, the average peak micromotion and the percentage of the contact area experiencing micromoitons less than 50 microns. Results and discussion. Similar trends were observed for all three designs across the range of activities. Stair ascent and descent generated the highest micromotions, closely followed by level gait. Across these three activities the mean peak (maximum) micromotions ranged from 64-78 (186-239) microns for PFC Sigma, 61-72 (199-251) microns for Duofix and 92-106 (229-264) microns for LCS. The peak micromotions did not necessarily occur at the peak loads. For instance, for level walking the peak micromotions occurred when there were low axial forces, but moderate varus-valgus moments. This highlights the need to examine the whole gait cycle in order to properly determine the initial stability tibiae tray designs. By exploring a range of activities and interrogating the entire contact surface, it is easier to differentiate between the relative performance of different implant designs

Introduction. The number of young and more active patients requiring total knee replacement (TKR) is increasing. Preclinical evaluation and understanding the long-term failure of TKR is therefore important. Preclinical wear simulation of TKR is usually performed according to the International Standards Organization (ISO) recommendations. Two international standards for preclinical wear simulation of TKRs have been developed so that the anterior-posterior (AP) translation and internal-external (IE) rotation can be driven in either force or displacement control. However, the effects of using different control regimes on the kinematics and wear of the same TKR have not been investigated. The current study investigated the kinematics, contact mechanics and wear performance of a TKR when running under ISO force and displacement control standards using an experimentally validated computational model. Materials/Methods. Three different ISO control standards were investigated using a size C Sigma curved TKR (DePuy, UK), with moderately cross-linked UHMWPE curved inserts; ISO-14243-3-2004, ISO-14243-3-2014 and ISO- 14243-1-2009. Axial force and flexion-extension angle are common for the three standards. AP and IE motions are displacement controlled in ISO-14243-3-2004 and ISO-14243-3-2014, with the only difference being a reversal of AP polarity between the two standards, and are force controlled in ISO-14243-1-2009. The test setup and soft tissue constraints were defined in accordance with ISO recommendations. The wear model was based on the modification of Archard's law where the wear volume is defined as a function of contact area, sliding distance, cross-shear and contact stress. The simulation framework has been independently validated against experimental wear rates under three different standard and highly demanding daily activities (Abdelgaied et al. 2018). Results. Reversing AP in the displacement control ISO-2014, compared to ISO-2004, resulted in high contact stresses of more than 70 MPa in the posterior direction. The predicted AP and IE from the force control ISO-2009 were in different directions and magnitudes to ISO-2014 AP and IE. The predicted wear rates were 1.8, 2.0, and 5.5 [mm. 3. /mc] for ISO-14243-3-2004, ISO-14243-3-2014 and ISO-14243-1-2009 respectively. Discussion. Reversing AP in the displacement control ISO-2014, without revising the femoral centre of rotation, resulted in high stress edge loading in the posterior direction, due to femoral rollback, and more than 10% increase in wear rate compared to ISO-2004. The predicted AP and IE from the force control ISO-2009 had different polarities and magnitudes to the corresponding displacement control ISO-2014 AP and IE. In addition, the predicted wear rate under the force control ISO-2009 was more than double that measured under displacement control standards due to the increased AP and IE motions predicted under the force control standard. In addition to the previous validation of the model, the predicted wear rate under the force control ISO-2009 of 5.5 mm. 3. /mc was within the 95% confidence limits of the reported experimental wear rate for the same TKR of 4.71±1.29 mm. 3. /mc (Johnston et al. 2018) which gives more confidence in the model. Conclusion. The study showed significant differences between ISO force and displacement control standards and between ISO displacement standards with different AP polarities. These differences should therefore be considered when choosing a control regime for preclinical simulation of TKR