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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 5 - 5
1 Apr 2019
Wilson C Sires J Lennon S Inglis M
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Introduction. Despite improvement in implants and surgical techniques up to 20% of Total Knee Arthroplasty TKA patients continue to report dissatisfaction. The ATTUNE Knee System was designed to provide better patellar tracking and stability through the mid-range of flexion and therefore improve patient outcomes and satisfaction. Aims. The aims of this study were to assess patient outcomes in a consecutive series of ATTUNE TKA and ensure early results were comparable to other TKA systems in Australia. Methods. Between September 2014 and December 2015, 332 ATTUNE TKR's were implanted locally. All patients in our learning curve from case 1 were included. Mean follow-up was 2.6 years (range: 2.0–3.2). Revision, complications and postoperative ROM was collected. Patient reported outcome was measured using the Multi-Attribute Arthritis Prioritization Tool (MAPT) questionnaire. Revision rates were cross checked with an AOANJRR Ad Hoc report. Results. Revision rate of the ATTUNE TKR was lower than national rates, however not statistically different (1.6% vs. 2.1%) (p=0.508). Postoperative MAPT scores were significantly lower after TKR (median 63.4 vs. 0.0) (p<0.001). A total of 86.7% patients had a good outcome postoperative TKR (MAPT≤ 20). Conclusion. Our findings suggest the ATTUNE TKR has comparable revision rates to other TKRs currently available in Australia. Furthermore, patient reported outcome was high 2.8 years postoperatively, with 85% patient satisfaction


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 46 - 46
1 Feb 2020
Currier J Currier B Jevsevar K Van Citters D
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Introduction

In an effort to provide a TKA bearing material that balances resistance to wear, mechanical failure and oxidation, manufacturers introduced antioxidant polyethylene. In many designs, this is accomplished through pre-blending the polymer with the antioxidant before consolidation and radiation crosslinking. This study reports the wear performance (in terms of thickness change) of a hindered phenol (PBHP) UHMWPE from analysis of an early series of knee retrievals and explores these questions: 1) What is early-time performance of this new bearing material? 2) Is there a difference in performance between fixed and mobile bearings in this design? 3) How does quantitative surface analysis help understand performance at the insert-tray modular interface?

Methods

A series of 100 consecutive Attune™ knee inserts (DePuy Synthes, Warsaw, IN) received at revision by an IRB approved retrieval laboratory between September 2014 and March 2019 were investigated. In vivo duration was 0–52 months. Both the fixed bearing design (n=74) and the rotating platform mobile bearing design (n=26) were included. Dimensional change was determined by measurement of each insert and compared to the as-manufactured dimensions, provided by the manufacturer. The insert-tray interfaces under the loaded bearing zones were analyzed with light interferometry using an optical surface profiler (NewView™ 7300, Zygo, Middlefield, CT). Statistical analyses to explore relationships between measured variables were conducted using SPSS.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 49 - 49
1 Feb 2017
Huey V Brenkel I Chang C Clatworthy M Hamilton W Howard J Kantor S Lesko J Nunley R Whittaker J Verdonk P
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Introduction. With the introduction of new technology in orthopaedics, surgeons must balance anticipated benefits in patient outcomes with challenges or complications associated with surgical learning curve for the technology. The purpose of this study was to determine whether the surgeon learning curve with a new multi-radius primary TKA system (primary TKA implant and instruments) designed for surgical team ease would impact clinical outcomes, surgical time and complications. Materials & Methods. From November 2012 to July 2015, 2369 primary TKAs were prospectively enrolled in two multicenter studies across 50 sites in 14 countries with a new knee system (ATTUNE®) evenly balanced across four configurations: cruciate retaining or posterior stabilised with either fixed bearing or rotating platform (CRFB, CRRP, PSFB, PSRP). 2261 knees had a <1 year visit and 1628 had a greater than 1 year visit. These knees were compared to a reference dataset of 845 primary TKAs from three manufacturers in the same four configurations with currently available products (CURRENT-TKA). Demographics for ATTUNE and CURRENT-TKA were similar and typical for primary TKA. Operative times, clinical outcomes and a series of five patient reported outcomes were compared for ATTUNE vs. CURRENT-TKA. The first 10 ATTUNE subjects for each surgeon were defined as learning curve cases (N=520) and were compared to all later subjects (N=1849) and also with the CURRENT-TKA cases (N=845). Patient reported outcome measures and clinical outcome analyses were adjusted for covariates including patient demographics, pre-op assessment and days post-op. Results. Mean (SD) surgical time for ATTUNE learning curve cases was 79.3 (24.7) minutes, which reduced thereafter to 73.6 (24.3) (p<0.001). Beyond 10 cases, there was a continued reduction in ATTUNE surgical time (R-Squared = 0.031). After 10 cases, surgical time was on par with the mean (SD) 72.0 (21.7) for CURRENT-TKA (p=0.097). PROM outcomes of the first 10 learning curve cases for ATTUNE were not statistically different from later cases at less than 1 year or later when adjusted for relevant covariates including configuration, patient demographics, pre-op functional status, and time post-op (p-values > 0.01). PROM outcomes for ATTUNE vs. CURRENT-TKA under the same covariate adjustments showed a trend favoring KOOS ADL, Symptoms, and Sport and Recreation subscores at minimum 1 year (p-values < 0.05). The incidence of intraoperative operative site (knee) complications was 1.3% (7/520) for the ATTUNE learning curve cases which was similar to both the 0.6% (5/845) rate for historical CURRENT-TKA (p=0.230) and the 0.8% (14/1849) intraoperative complication rate for the ATTUNE later cases (p=0.195). Discussion. The introduction of new implants into the market place needs to have adequate data to support that they are safe and effective. Except for a minor increase in surgical time during the first 10 patients, this study found that surgeon learning curve with the new ATTUNE primary TKA system does not adversely affect patient short term outcomes and complication rates


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 37 - 37
1 May 2016
Berahmani S Janssen D Wolfson D Hendriks M Wright A Malefijt M Verdonschot N
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To achieve a long-lasting fixation of uncemented femoral knee implants, an adequate primary stability is required. Several factors, including the applied load, bone quality, surgical preparation, and implant characteristics affect the primary fixation. Recently, novel Attune® cementless femoral component has been proposed by DePuy Synthes (Warsaw, IN, USA). We aimed to compare the primary stability of this novel high-flex design against the conventional LCS® under different loading conditions (gait, deep knee bend (DKB), and high-flex loading), while accounting for the effect of bone quality and cut accuracy. Six pairs of femora were prepared following the normal surgical procedure. Calibrated CT-scans and 3D-optical scans of the bones were obtained to measure bone mineral density (BMD) and bone cut accuracy, respectively. After implantation of the appropriate size implants (Left legs: Attune; right: LCS), a black-and-white speckle pattern was applied to each specimen (Fig.1B). The micromotion measurement was repeated three times in nine regions of interest (ROIs): the medial and lateral condyles from the posterior view; anterior, distal, and posterior regions from the medial and lateral views; the proximal tip of the anterior flange. The reconstructions were subjected to a gait load and a portion (around 50%) of the peak force of a DKB to prevent fracture of the proximal femur (Fig. 1A and Table. 1). The loads were derived from the Orthoload database using implant-specific inverse dynamics [1]. In addition, a sequence of DIC-images synchronized with the applied load was captured to find the relationship between micromotion and load. Afterwards, implants were pushed-off simulating 150° of flexion, while force-displacement graph was recorded. BMD and bone cut accuracy were not significantly different between the groups. Under both loading conditions, Attune had a significantly lower micromotion (Table. 1). Cut accuracy was not a significant factor, and BMD was only significant for the comparison under the gait loading (not under DKB conditions). High-flex push-off force was not significantly different. However, Attune required a significantly higher load to reach a micromotion of 50 or 150 µm during the push-off test. Different relations between micromotion and applied load, depending on the loading configuration and implant design, were found (Fig. 2). Our study has shown a clearly lower range of micromotion for the novel implant. Potential factors to explain the higher micromotion of LCS are parallel anterior and posterior bone cuts in the LCS versus the tapered bone cuts of the Attune. In addition, LCS has a less surface area in contact with bone due to the presence of a rim at the borders of the implant, which may have resulted in lower pre-stresses at the bone-implant interface. Taking to account, the promising clinical outcome of LCS and also the lower range of micromotion of Attune, we suggest that the Attune has a potential to be at least as successful as the LCS system from a bone fixation point of view. However, further clinical evaluation of the Attune is necessary to assess its performance on the longer term


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 98 - 98
1 Feb 2017
Dickinson M Shalhoub S Fitzwater F Clary C Maletsky L
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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


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 131 - 131
1 Apr 2019
Peckenpaugh E Maag C Metcalfe A Langhorn J Heldreth M
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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


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 32 - 32
1 Feb 2020
Maag C Peckenpaugh E Metcalfe A Langhorn J Heldreth M
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Introduction. Aseptic loosening is one of the highest causes for revision in total knee arthroplasty (TKA). With growing interest in anatomically aligned (AA) TKA, it is important to understand if this surgical technique affects cemented tibial fixation any differently than mechanical alignment (MA). Previous studies have shown that lipid/marrow infiltration (LMI) during implantation may significantly reduce fixation of tibial implants to bone analogs [1]. This study aims to investigate the effect of surgical alignment on fixation failure load after physiological loading. Methods. Alignment specific physiological loading was determined using telemetric tibial implant data from Orthoload [2] and applying it to a validated finite element lower limb model developed by the University of Denver [3]. Two high demand activities were selected for the loading section of this study: step down (SD) and deep knee bend (DKB). Using the lower limb model, hip and ankle external boundary conditions were applied to the ATTUNE. ®. knee system for both MA and AA techniques. The 6 degree of freedom kinetics and kinematics for each activity were then extracted from the model for each alignment type. Mechanical alignment (MA) was considered to be neutral alignment (0° Hip Knee Ankle Angle (HKA), 0° Joint Line (JL)) and AA was chosen to be 3° varus HKA, 5° JL. It is important not to exceed the limits of safety when using AA as such it is noted that DePuy Synthes recommends staying within 3º varus HKA and 3º JL. The use of 5º JL was used in this study to account for surgical variation [Depuy-Synthes surgical technique DSUS/JRC/0617/2179]. Following a similar method described by Maag et al [1] ATTUNE tibial implants were cemented into 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. Tibial implant constructs were then subjected to intra-operative ROM/stability evaluation, followed by a hyperextension activity until 15 minutes of cement curing time, and finally 3 additional ROM/stability evaluations were performed using an AMTI VIVO simulator. The alignment specific loading parameters were then applied to the tibial implants using an AMTI VIVO simulator. Each sample was subjected to 50,000 DKB cycles and 120,000 SD cycles at 0.8 Hz in series; approximating 2 years of physiological activity. After physiological loading the samples were tested for fixation failure load by axial pull off. Results. Following alignment specific physiological loading the average fixation pull-off load for MA was 3289 ± 400 N and for AA was 3378 ± 133 N (Figure 1). There was no statistically significant difference fixation failure load by axial pull-off between the two alignment types (p=0.740). Conclusion. This study indicated that anatomic alignment, as defined with the alignment limits of this study, does not adversely affect the fixation failure load of ATTUNE tibial implants. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 63 - 63
1 Feb 2020
Darwish O Langhorn J Van Citters D Metcalfe A
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Introduction. Patella implant research is often overlooked despite its importance as the third compartment in a total knee replacement. Wear and fracture of resurfaced patellae can lead to implant failure and revision surgeries. New simulation techniques have been developed to analyze the performance of patella designs as they interact with the trochlear groove in total knee components, and clinical validation is sought to ensure that these simulations are appropriate. The objective of this work was to subject several patellar designs to patient-derived deep knee bend (DKB) inputs on a 6 degree of freedom (DOF) simulator and compare the resultant wear scars to clinical retrievals. Materials and Methods. Previously reported DKB profiles were developed based on in vivo patellofemoral data and include a wide range of patient variability. The profiles chosen for this body of work were based on the stress in the patellar lateral facet; maximizing this stress whilst maintaining the ability to run the profile stably on the simulator. Load/kinematic profiles were run on three patellar designs (n=3 per group) for 220,000 cycles at 0.8Hz on an AMTI VIVO joint simulator. A comparison cohort of clinically retrieved devices of the same design was identified in an IRB-approved database. Exclusion criteria included gross delamination, cracking secondary to oxidation, and surgeon-reported evidence of malalignment leading to mal-tracking. 29 Patellae were included for analysis: PFC. ®. All Poly (n=14), ATTUNE. ®. Anatomic (n=6), and ATTUNE. ®. Medialized Dome (n=9). Mean in vivo duration was 70.1 months. Patellae were analyzed under optical microscope in large-depth-of-field mode to map the surface damage profile. Burnishing ‘heat-maps’ were generated for retrievals and simulated patellae by normalizing the patellar size and overlaying silhouettes from each component of the same type using a custom-developed MatLAB code. Results. Burnishing heat-map comparisons between retrievals and simulator specimens for each of the three designs were compared. Retrievals show more variation than simulator devices, however the general loci and relative area of burnished regions is closely aligned for each of the three designs. The retrieved and simulated burnishing scar heat-maps on all-poly PFC. ®. patellae are centered medio-laterally with a wider profile on the lateral aspect. The burnishing marks are continuous. A similar observation may be made of the ATTUNE. ®. medialized dome, retrievals and simulator specimens, though the contact areas appear to be more concentrated away from the apex. The anatomic patellae show two primary regions of contact, and minimal burnishing at the apex. The simulator specimens likewise show two principal regions of contact. Discussion. Wear scar analysis shows that joint simulation on AMTI VIVO yields clinically relevant wear patterns across a variety of device types. Clinically relevant damage provides insight that load and motion inputs to the simulator deliver results that may be used to interpret in vivo performance or analyze future designs and/or materials. This qualitative surface contact analysis will help to inform future quantitative mass loss and fatigue failure studies. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 29 - 29
23 Feb 2023
Abdul NM Yates P Bernard T
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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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 139 - 139
1 Mar 2013
Brockett C Hardaker C Fisher J Jennings L
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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


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 128 - 128
1 Jan 2016
Ranawat A Meftah M Ranawat C
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Introduction. Anterior knee pain (AKP) is a recognized cause of patient's dissatisfaction after total knee arthroplasty. Potential implant/technique related contributors to AKP are patellofemoral maltracking, trochlear geometry, femoral malrotation, patellar tilt and overstuffing. The primary aim of this prospective, matched pair study was to assess the safety, efficacy and performance of an anatomic patella and its effect on AKP in in a matched pair analysis. Material and Methods. Between July 2012 and May 2013, 55 consecutive posterior stabilized cemented Attune TKAs (Depuy) were matched to the PFC Sigma group based on age, gender, and body mass index (BMI). All surgeries were performed via medial parapatellar approach with patellar resurfacing. Clinical and radiographic analysis was performed prospectively with minimum 6 month follow-up. Radiographic measurements included overall limb alignment, anterior offset, posterior offset, joint line, patellar thickness, patellar tilt and patellar displacement by two independent observers. Results. The mean functional outcomes were similar in both groups. AKP incidence between Attune and PFC was statistically insignificant (3.6% and 3.8%). Radiographic analysis revealed no mal-alignment, or osteolysis. No complications such as infection, patellar fracture, subluxation or dislocations were observed. Discussion. Attune knee design demonstrates excellent short-term safety and efficacy. At minimum 6-month follow-up, anatomical patella with shows less AKP than single radius patella design. Longer follow-up is required to assess functional outcome this design


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 295 - 295
1 Dec 2013
Dressler M Owens B Metcalfe A Clary C Heldreth M
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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


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 130 - 130
1 Jan 2016
Park C Ranawat CS Ranawat AS
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Introduction. Potential implant and technique related factors to improve patellofemoral (PF) kinematics in total knee arthroplasty (TKA) are design of trochlear geometry and patella, restoration of posterior offset, patellar tilt and avoid overstuffing. The primary aim of this prospective, matched pair study was to assess the radiographic features of PF kinematics with an anatomic patella. Material and Methods. Between July 2012 and May 2013, 49 consecutive posterior stabilized cemented Attune TKAs (Depuy Synthes Warsaw Indiana) were matched to the 49 PFC Sigma (Depuy) based on age, gender, and body mass index (BMI). All surgeries were performed via medial parapatellar approach with patellar resurfacing. Radiographic analysis was performed prospectively with minimum 1-year follow-up and included overall limb alignment, anterior offset, posterior offset, joint line, patellar thickness, patellar tilt and patellar displacement by two independent observers. Results. We found significant improvement in all post-operative radiographies parameters from prior to surgery, however, there was no significance between the two groups (Table 1). Posterior offset and joint line were restored in all cases and no overstuffing of the PF joint was seen. Discussion. At minimum one-year follow-up, anatomical patella has excellent safety and efficacy with restoration of the PF kinematics. Metalized design of the Attune anatomic patella component allows better contact with trochlear groove and improves tilt with lateralization of the patella


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 44 - 44
1 Feb 2021
Edwards T Patel A Szyszka B Coombs A Kucheria R Cobb J Logishetty K
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Background. Revision total knee arthroplasty (rTKA) is a high stakes procedure with complex equipment and multiple steps. For rTKA using the ATTUNE system revising femoral and tibial components with sleeves and stems, there are over 240 pieces of equipment that require correct assembly at the appropriate time. Due to changing teams, work rotas, and the infrequency of rTKR, scrub nurses may encounter these operations infrequently and often rely heavily on company representatives to guide them. In turn, this delays and interrupts surgical efficiency and can result in error. This study investigates the impact of a fully immersive virtual reality (VR) curriculum on training scrub nurses in technical skills and knowledge of performing a complex rTKA, to improve efficiency and reduce error. Method. Ten orthopaedic scrub nurses were recruited and trained in four VR sessions over a 4-week period. Each VR session involved a guided mode, where participants were taught the steps of rTKA surgery by the simulator in a simulated operating theatre. The latter 3 sessions involved a guided mode followed by an unguided VR assessment. Outcome measures in the unguided assessment were related to procedural sequence, duration of surgery and efficiency of movement. Transfer of skills was assessed during a pre-training and post-training assessment, where participants completed multi-step instrument selection and assembly using the real equipment. A pre and post-training questionnaire assessed the participants knowledge, confidence and anxiety. Results. All participants reported orthopaedics as their primary speciality with mean of 6-years experience. 80% reported they are ‘sometimes’ required to scrub for operations in which they do not feel comfortable with the equipment. All participants improved across the 3 unguided sessions reducing their operative time by 47%, assistive prompts by 75%, dominant hand motion by 28% and head motion by 36%. This transferred into the real-world: Participants completed 11.3% of tasks correctly in pre-training compared to 83.5% correct in the timely selection and assembly of rTKA equipment, post-training. All participants reported increased confidence and reduced anxiety after the training. Conclusion. Unfamiliarity with orthopaedic procedures or equipment is common for scrub nurses and can impact surgical performance. VR training improves their understanding, technical skills and efficiency in complex rTKA. These VR-learnt skills translate into the physical environment. This has important implications on how scrub nurses can be trained remotely, asynchronously and safely to perform complex orthopaedic surgery


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 33 - 33
1 Feb 2020
Maag C Cracaoanu I Langhorn J Heldreth M
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INTRODUCTION. Implant wear testing is traditionally undertaken using standardized inputs set out by ISO or ASTM. These inputs are based on a single individual performing a single activity with a specific implant. Standardization helps ensure that implants are tested to a known set of parameters from which comparisons may be drawn but it has limitations as patients perform varied activities, with different implant sizes and designs that produce different kinematics/kinetics. In this study, wear performance has been evaluated using gait implant specific loading/kinematics and comparing to a combination deep knee bend (DKB), step down (SD) and gait implant specific loading on cruciate retaining (CR) rotating platform (RP) total knee replacements (TKR). This combination activity profile better replicates patient activities of daily living (ADL). METHODS. Two sets of three ATTUNE. ®. size 5 right leg CR RP TKRs (DePuy Synthes, Warsaw, IN) were used in a study to evaluate ADL implant wear. Implant specific loading profiles were produced via a validated finite element lower limb model [1] that uses activity data such as gait (K1L_110108_1_86p), SD (K1L_240309_2_144p), and DKB (K9P_2239_0_9_I1) from the Orthoload database [2] to produce external boundary conditions. Each set of components were tested using a VIVO joint simulator (AMTI, Watertown, MA, Figure 1) for a total of 4.5 million cycles (Mcyc). All cycles were conducted at 0.8Hz in force-control with flexion driven in displacement control. Bovine calf serum lubricant was prepared to a total protein concentration of 18g/L and maintained at 37°±2°C. Wear of the tibial inserts was quantified via gravimetric methods per ISO14243–2:2009(E). Polyethylene tibial insert weights were taken prior to testing and every 0.5Mcyc there after which corresponded to serum exchange intervals. The multi-activity test intervals were split into10 loops of 1,250 DKB, 3,000 SD, and 45,750 gait cycles in series. Based on activity data presented by Wimmer et al. the number of cycles per activity and activities used is sufficient for a person that is considered active [3]. A loaded soak control was used to compensate for fluid absorption in wear rate calculations. Wear rates were calculated using linear regression. RESULTS SECTION. The wear rate for the gait-only activity test was calculated to be 0.20±0.04mg/Mcyc conversely the wear rate for the multi-activity test was 2.65±0.67mg/Mcyc (Figure 2). Wear scars can be found in Figure 3. Using a two-sided t-test of unequal variance, it was found that there was a significant difference between the two wear rates (p=0.004). DISCUSSION. Adding activities to the wear simulation test significantly increased the average wear rate of the test samples, confirming that changes in cross shear from different activities will tend to increase the wear of an implant. The results of this study prove that single activity wear testing may not be the most clinically severe wear testing that can be used for pre-clinical wear assessment. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 113 - 113
1 Feb 2017
Lee S
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Objectives. The purpose of this study was to evaluate the impact of multi-radius (MR, n=20) versus gradually reducing radius (GR, n=18) knee design on the kinematics and kinetics of the knee during level ground walking one year after total knee arthroplasty. Materials and Methods. Thirty-eight knees with end-stage knee osteoarthritis were examined before and one year after total knee arthroplasty. The groups consisted of subjects who had undergone total knee arthroplasty with a representative MR designed implant (B Braun-Aesculap Vega. ®. Knee System) and a representative GR designed implant (Depuy Attune. ®. Knee System) (Figure 1). The kinematic and kinetic parameters of knee varus angle, first peak knee adduction moment, sagittal plane knee excursion and extensor moment were evaluated during gait, as well as the spatiotemporal gait outcomes of walking speed, stride length, cadence, step length, the percentage of stance phase. Comparisons of preoperative and postoperative outcomes were done by the paired t-test. Independent t-test was also done to compare the postoperative outcomes of MR designed implant and GR designed implant. Results. In spatiotemporal parameters of GR implant group, there was an increase in walking speed, stride length and cadence (all p<0.05) and no change in step length and the percentage of stance phase postoperatively. GR implant group showed large reductions in varus angle and adduction moment (all p<0.001), a significant increase in extensor moment (p=0.01), and a small reduction in sagittal plane excursion (p=0.04) after surgery. In comparison of two groups at one year after surgery, there were no significant differences of all spatiotemporal, kinematic and kinetic parameters between two groups except varus angle. GR implant group showed more reduction in varus angle than MR implant group (p=0.01). Conclusions. Total knee arthroplasty performed with gradually reducing radius knee design reduces frontal plane loading patterns of knee varus angle and adduction moment and provided improvement in spatiotemporal parameters. Post-operatively there were no statistical differences between the MR implant group and the GR implant group in any of the kinematic and kinetic measures except knee varus angle during level ground walking


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 49 - 49
1 Feb 2017
Bonnin M Saffarini M Victor J
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Purpose. Analysis of the morphology of the distal femur, and by extension of the femoral components in total knee arthroplasty (TKA), has been related to the aspect ratio, which represents the width of the femur. Little is known about variations in trapezoidicity (i.e whether the femur is more rectangular or more trapezoidal). This study aimed to quantify additional morphological characteristics of the distal femur and identify anatomical features associated with higher risks of over- or under-sizing of components in TKA. Method. We analyzed the shape of 114 arthritic knees at the time of primary TKA using the pre-operative CT scans. The maximum AP dimension was measured. The mediolateral dimensions were measured on the theoretical distal resection slice at three levels: the posterior region (MLP), the central region (MLC) and the anterior region (MLA) (Fig 1). The ‘aspect’ ratio (MLC/AP) ratio quantified how wide or narrow the shape is. The ‘trapezoidicity’ ratio (MLP/MLA) ratio quantified how rectangular or trapezoidal the shape is. We also quantified the medial and lateral ‘narrowing angles’ in the anterior and central zones (α and β) (Fig 2). The post-operative prosthetic overhang was calculated from CT-scan. We compared the morphological characteristics with those of twelve TKA models scanned using a three-dimensional optical scanning machine (ATOS II, GOM mbH, Braunschweig, Germany) and its photogrammetric analysis software (TRITOP, GOM mbH, Braunschweig, Germany). Results. There were significant variations in both the aspect ratio (1.16±0.07; range 0.98–1.31) and the trapezoidicity ratio (1.21±0.08; range 1.06– 1.46). Femoral trapezoidicity was mostly due to an inward curve of the medial cortex. The multivariate analysis indicated that prosthetic overhang was correlated to the ‘aspect ratio’ (more overhang in narrow femurs, p=0.002), to the ‘trapezoidicity ratio’ (more overhang in trapezoidal femurs, p=0.002), and to the Tibio Femoral Angle (more overhang in valgus knees, p=0.035). The geometries of the twelve specimen components can be compared directly with the morphological findings of this study. Some components had excessively low trapezoidicity ratios (i.e. were too rectangular) such as DePuy LCS and Stryker Scorpio. Other designs had trapezoidicity ratios closer to anatomic values such as Zimmer Nexgen, Zimmer Persona, DePuy Attune and Smith and Nephew Journey (Fig 3). Several components had excessively low anterior lateral narrowing angle (αL) such as DePuy LCS, Stryker Scorpio. All had insufficiently low medial narrowing angles. Conclusion. This study shows that rectangular/trapezoidal variability of the distal femur cannot be ignored. Most of the femoral components, which were tested appeared to be excessively rectangular when compared with the bony contours of the distal femur. These findings suggest that the design of TKA should be more concerned with matching the trapezoidal/rectangular shape of the native femur


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 18 - 18
1 May 2016
Bruni D Marcacci M Bignozzi S Zaffagnini S Iacono F
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Introduction. Proper alignment (tibial alignment, femoral alignment, and overall anatomic alignment) of the prosthesis during total knee replacement is critical in maximizing implant survival[7] and to reduce polyethylene wear[1]. Poor overall anatomic alignment of a total knee replacement was associated with a 6.9 times greater risk of failure due to tibial collapse, that varus tibial alignment is associated with a 3.2 times greater risk[2] and valgus femoral alignment is associated with a 5.1 times greater risk of failure[7]. To reduce this variability intramedullary (IM) instruments have been widely used, with increased risk of the fat emboli rate to the lungs and brain during TKA[6] and possible increase of blood loss[4, 5]. Or, alternatively, navigation has been used to achieve proper alignment and to reduce morbidity[3]. Recently, for distal femoral resection, inertial sensors have been coupled to extramedullary (EM) instruments to improve TKA surgery in terms of femoral implant alignment, with respect to femoral mechanical axis, and reduced morbidity by avoidance of IM canal violation. The purpose if this study is to compare blood loss and alignment of distal femoral cut in three cohorts of patients: 1 Operated with inertial based cutting guide; 2 Operated with navigation instruments; 3 operated with conventional IM instruments. Material and methods. From September to November 2014 30 consecutive patients, eligible for TKA, were randomly divided into three cohorts with 10 patients each:x 1 “EM Perseus”, patient operated with EM inertial based instruments (Perseus, Orthokey Italia srl, Florence, Italy); 2 “EM Nav”, operated with standard navigated technique, where bone resections were planned and verified by mean of navigation system (BLUIGS, Orthokey Italia srl, Florence, Italy); 3 “IM Conv”, operated with standard IM instrumentation. All patients were operated by the same surgical technique, implanted TKA were mobile bearing PS models, Gemini (Waldemar Link, Hamburg, Germany) and Attune (Depuy, Warsaw, Indiana). Anteroposterior, lateral, and full-limb weightbearing views preoperatively and postoperatively at discharge were obtained, taking care of neutral limb rotational positioning in all patients enrolled in the study. Angles between femoral mechanical axis and implant orientation on frontal and lateral planes were measured with a CAD software (Rhinoceros 3, McNeel Europe, Rome, Italy) by two independent persons, average value was used for statistical analysis. Haemoglobin values were recorded at three time intervals: the day before surgery, at 24h follow-up and at patients discharge. Statistical analysis. Kruskal-Wallis test was used to compare differences between the three cohorts in blood loss and femoral implant alignment. Results. All the three cohorts were comparable in terms of age, sex, preoperative limb alignment and preoperative haemoglobin values (Tab. 1). Haemoglobin ad discharge was reduced for all three cohorts (Tab. 2), no significant differences was found even if IM Conv group showed higher loss compared to EM Perseus and EM Nav groups. Femoral implant alignment deviation, considering perpendicularity with femoral mechanical axis as goal, was comparable in frontal and lateral plane for all three cohorts (Tab. 2). Discussion. The aim of the study was to compare the accuracy in femoral component positioning, on the coronal and sagittal plane obtained with a new inertial based EM instrument, with a standard IM distal femoral cutting jig and with navigation. We confirm our hypothesis that the use of inertial based EM instruments to perform the distal femoral bone cut in TKA is reliable and at least as accurate as the standard IM technique and navigation. Our study did not show a statistical decrease in blood loss when the femoral canal was not reamed (in inertial based EM, and navigated groups), even if patient operated with IM instruments had sensibly higher blood loss compared to the other two groups. This study was not exactly powered for that purpose, a study with a larger cohort and strict patient selection criteria would be required. This study demonstrates that inertial based EM instruments is accurate for femoral component alignment in TKA and compares favorably to navigation systems and standard IM techniques. Other indications for the use of inertial based EM instruments include all major femoral extraarticular deformities, the presence of ipsilateral long-stemmed hip arthroplasty, and the presence of hardware such as distal femoral plates and screws or IM nails