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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 3 - 3
1 Dec 2020
Grupp TM Schilling C Fritz B Reyna ALP Pfaff A Taunt C Mihalko WM
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Introduction. Beneath infection, instability and malalignment, aseptic tibial component loosening remains a major cause of failure in total knee arthroplasty (TKA) [1]. This emphasizes the need for stable primary and long-term secondary fixation of tibial baseplates. To evaluate the primary stability of cemented tibial baseplates, different pre-clinical test methods have been undergone: finite element analysis [2], static push-out [3,4] or dynamic compression-shear loading [5] until interface failure. However, these test conditions do not reflect the long-term endurance under in vivo loading modes, where the tibial baseplate is predominantly subjected to compression and shear forces in a cyclic profile [5,6]. To distinguish between design parameters the aim of our study was to develop suitable pre-clinical test methods to evaluate the endurance of the implant-cement-bone interface fixation for tibial baseplates under severe anterior (method I) and internal-external torsional (method II) shear test conditions. Materials & Methods. To create a clinically relevant cement penetration pattern a 4. th. generation composite bone model was customised with a cancellous core (12.5 PCF cellular rigid PU foam) to enable for high cycle endurance testing. VEGA System. ®. PS & Columbus. ®. CRA/PSA ZrN-multilayer coated tibial baseplates (2×12) were implanted in the customised bone model using Palacos. ®. R HV bone cement (Figure 1). An anterior compression-shear test (method II) was conducted at 2500 N for 10 million cycles and continued at 3000 N & 3500 N for each 1 million cycles (total: 12 million cycles) simulating post-cam engagement at 45° flexion. An internal-external torsional shear test (method II) was executed in an exaggeration of clinically relevant rotations [7,8] with ±17.2° for 1 million cycles at 3000 N tibio-femoral load in extension. After endurance testing either under anterior shear or internal-external torsion each tibial baseplate was mounted into a testing frame and maximum push-out strength was determined [3]. Results. The cement penetration depth and characteristic pattern were comparable to 3D-CT scans of 24 cemented human tibiae from a previous study [5]. From the final push-out testing, no statistical significant differences could be found for anterior compression-shear testing (method I) with VEGA System. ®. PS (2674 ± 754 N) and Columbus. ®. CRA/PSA (2177 ± 429 N) (p = 0.191), as well as internal-external torsional shear testing (method II) between VEGA System. ®. PS (2561 ± 519 N) and Columbus. ®. CRA/PSA (2825 ± 515 N) tibial baseplates (p = 0.399). Discussion. The newly developed methods allow the evaluation of the endurance behaviour of the implant-cement-bone interface fixation for tibial baseplates in comparison to clinically long-term established knee systems, based on a combination of a suitable artificial bone model and severe anterior and internal-external torsional high cycle shear test conditions


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 2 - 2
1 Jul 2014
Gao B Angibaud L
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Summary Statement. The constraint behavior of total knee arthroplasty (TKA) prosthesis usually has to be physically tested. This study presents a computer simulation model using finite element analysis (FEA) and demonstrates its effectiveness in predicting the femorotibial constraint behavior of TKA implants. Introduction. TKA prostheses are semi-constrained artificial joints. A well-functioning TKA prosthesis should be designed with a good balance between stability and mobility, meaning the femorotibial constraint of the artificial joint cannot be excessive or too lax. To assess the constraint behavior of a TKA prosthesis, physical testing is usually required, and an industrial test standard has been developed for this purpose. Benefiting from technological advancement, computer simulation has become increasingly useful in many industries, including medical device research and development. FEA has been extensively used in stress analysis and structural evaluation of various orthopaedic implants. This study presented an FEA-based simulation to evaluate the femorotibial constraint behavior of TKA prosthesis, and demonstrated the effectiveness of the method by validating it through physical testing. Methods. A Cruciate Retaining (CR) TKA prosthesis design (Optetrak Logic CR, size 3, Exactech, FL, USA) was used in this study. The prosthesis system consists of a femoral component, a tibial insert, and a tibial baseplate. CAD models of the implants assembled at 0° of flexion were used for the simulation. Finite element models were generated using 10-node tetrahedral elements, with all materials considered linear elastic. Boundary conditions were set up according to the ASTM F1223 standard. The tibial baseplate was fixed distally. A constant compressive force (710 N) was applied on the femoral component. Nonlinear Surface-Surface-Contact was defined at the femorotibial articulating surfaces as well as between the tibial insert and tibial baseplate. A coefficient of friction of 0.2 determined from the physical test was input into the simulation. The femoral component was driven under a displacement-controlled scheme to slide along the anterior-posterior (AP) direction on the tibial insert. At each time step, constraint force occurring at the articulating surface was derived from the reaction force at the distal fixation of the tibial baseplate. The force-displacement curve was plotted by combining the results of all time steps to characterize the constraint behavior of the prosthesis. A nonlinear FEA solver (NX Nastran SOL601, Siemens, TX, USA) was used to solve the simulation. In addition, five samples of the prostheses were physically tested per ASTM F1223. Simulation results were compared to the physical testing. Results. The simulation successfully captured the movement of contact location and pressure along the movement of the femoral component. The force-displacement curve predicted by the simulation exhibited a very close hysteresis loop profile as the results of physical testing. Using the curve slope from 0 to 5 mm to characterise the constraint in the most relevant displacement range, the simulation predicted 45.7 N/mm anteriorly and 36.4 N/mm posteriorly, which are less than 10% different from the physical testing results (46.4 N/mm anteriorly and 39.6 N/mm posteriorly). Discussion/Conclusion. This study demonstrated that the simulation was able to closely predict the femorotibial constraint behavior of the TKA prosthesis under ASTM F1223 testing. The simulation results resembled the physical test results not only in the general profile of the curve but also in the magnitude of slope values. The increased difference at the far anterior region could be related to the fact that no material nonlinearity was considered in the current simulation, a factor that could be improved in future studies. A validated simulation method could be very useful in TKA prosthesis design. Since no physical prototypes are required, design evaluation and optimization can be achieved in a much easier and faster manner


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 20 - 20
17 Nov 2023
van Duren B France J Berber R Matar H James P Bloch B
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Abstract. Objective. Up to 20% of patients can remain dissatisfied following TKR. A proportion of TKRs will need early revision with aseptic loosening the most common. The ATTUNE TKR was introduced in 2011 as successor to its predicate design The PFC Sigma (DePuy Synthes, Warsaw, In). However, following reports of early failures of the tibial component there have been ongoing concerns of increased loosening rates with the ATTUNE TKR. In 2017 a redesigned tibial baseplate (S+) was introduced, which included cement pockets and an increased surface roughness to improve cement bonding. Given the concerns of early tibial loosening with the ATTUNE knee system, this study aimed to compare revision rates and those specific to aseptic loosening of the ATTUNE implant in comparison to an established predicate as well as other implant designs used in a high-volume arthroplasty centre. Methods. The Attune TKR was introduced to our unit in December 2011. Prior to this we routinely used a predicate design with an excellent long-term track record (PFC Sigma) which remains in use. In addition, other designs were available and used as per surgeon preference. Using a prospectively maintained database, we identified 10,202 patients who underwent primary cemented TKR at our institution between 01/04/2003–31/03/2022 with a minimum of 1 year follow-up (Mean 8.4years, range 1–20years): 1) 2406 with ATTUNE TKR (of which 557 were S+) 2) 4652 with PFC TKR 3) 3154 with other cemented designs. All implants were cemented using high viscosity cement. The primary outcome measures were all-cause revision, revision for aseptic loosening, and revision for tibial loosening. Kaplan-Meier survival analysis and Cox regression models were used to compare the primary outcomes between groups. Matched cohorts were selected from the ATTUNE subsets (original and S+) and PFC groups using the nearest neighbor method for radiographic analysis. Radiographs were assessed to compare the presence of radiolucent lines in the Attune S+, standard Attune, and PFC implants. Results. At a mean of 8.4 years follow-up, 308 implants underwent revision equating to 3.58 revisions per 1000 implant-years. The lowest risk of revision was noted in the ATTUNE cohort with 2.98 per 1000-implant-years where the PFC and All Other Implant groups were 3.15 and 4.4 respectively. Aseptic loosing was the most common cause for revision across all cemented implants with 76% (65/88) of involving loosening of the tibia. Survival analysis comparing the ATTUNE cohort to the PFC and All Other Cemented Implant cohorts showed no significant differences for: all-cause revision, aseptic loosening, or tibial loosening (p=0.15,0.77,0.47). Radiolucent lines were detected in 4.6%, 5.8%, and 5.0% of the ATTUNE S+, standard ATTUNE, and PFC groups respectively. These differences were not significant. Conclusion. This study represents the largest non-registry review of the original and S+ ATTUNE TKR in comparison to its predicate design as well as other cemented implants. There appears to be no significant increased revision rate for all-cause revision or aseptic loosening. Radiographic analysis also showed no significant difference in peri-implant radiolucency. It appears that concerns of early loosening may be unfounded. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 1 - 1
1 Jul 2014
Gao B Angibaud L
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Summary Statement. Femorotibial constraint is a key property of a total knee arthroplasty (TKA) prosthesis and should reflect the intended function of the device. With a validated simulation methodology, this study evaluated the constraint of two TKA prostheses designed for different intentions. Introduction. TKA prostheses are semi-constrained artificial joints. Femorotibial constraint level is a major property of a prosthesis and should be designed to match the device's intended function. Cruciate Retaining (CR) prostheses are usually indicated for patients with a functioning posterior cruciate ligament (PCL). For patients without a fully functioning PCL, CR-Constrained (CRC) prostheses with additional built-in constraint may be indicated. A CRC prosthesis usually consists of a CR femoral component and a tibial insert which has a more conforming sagittal profile to offer an increased femorotibial constraint. This study evaluated the anterior-posterior (AP) constraint behavior of two lines of prostheses (CR and CRC) from a same TKA product family. Using a validated computer simulation approach, multiple sizes of each product line were evaluated. Methods. Both the CR and CRC prostheses are from the same TKA product family (Optetrak Logic, Exactech, FL, USA) and share identical femoral components and tibial baseplates. The CRC tibial inserts have a more conforming sagittal profile than the CR tibial inserts, especially in the anterior aspect. Three sizes (sizes 1, 3, and 5) from each product line were included in this study. Computer simulations using finite element analysis (FEA) were performed to evaluate the femorotibial constraint of each prosthesis per ASTM F1223 standard [1]. The simulation has been validated by comparison with physical testing (more details submitted in a separate paper to CORS 2013). Briefly, FEA models were created using 10-node tetrahedral elements with all materials considered linear elastic. The tibial baseplate was distally fixed and a constant compressive force (710 N) was applied to the femoral component. Nonlinear Surface-Surface-Contact was established at the articulating surfaces, as well as between the tibial insert and the tibial baseplate. A coefficient of friction of 0.1 was assumed for all articulations [2]. The femoral component was driven under a displacement-controlled scheme to slide along AP direction on the tibial insert. Constraint force occurring at the articulation was derived from the reaction force at the distal fixation; thus, the force-displacement curve can be plotted to characterise the constraint behavior of the prosthesis. A nonlinear FEA solver (NX Nastran SOL601, Siemens, TX, USA) was used to solve the simulations. Results. The force-displacement curves predicted by the simulation exhibited the hysteresis loop appearance for both CR and CRC prostheses. The profile of the curves was generally consistent across different sizes for both product lines. The anterior constraint of the CRC prosthesis was significantly greater than the CR prosthesis. The posterior constraint of the CRC prosthesis was also slightly greater. Larger sizes exhibited reduced constraint compared to smaller sizes. Discussion/Conclusion. The increased constraint of the CRC prosthesis revealed in the study is consistent with the geometrical characteristics and the functional intent of the device. The CRC tibial insert is expected to provide significantly greater anterior constraint than the CR prosthesis to prevent paradoxical femoral translation when the patient's PCL is not fully functioning. The CRC tibial insert is also expected to provide slightly increased posterior constraint due to its elevated posterior lip. The observed hysteresis loop appearance is consistent with physical testing and the existence of friction. The reduced constraint on larger sizes is functionally desirable to offer proportional translation freedom. This study demonstrated the effectiveness of the simulation approach in quantifying the constraint behavior of different TKA prosthesis designs


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 9 - 9
1 Mar 2021
To K Khan W
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The current standard of practice following knee arthroplasty is to demonstrate the appropriate alignment of knee replacements using knee radiographs. Recent studies have suggested that standard knee radiographs provide adequate accuracy for tibial prosthesis alignment assessment as compared with long knee view radiographs which are more technically demanding and carry greater radiation exposure. In this study, we aim to address whether alignment measured on standard knee radiographs are reliable and reproducible over time. We examined a cohort of 80 patients 37 male (46%), 43 females (54%), mean age = 68 years) who underwent total knee arthroplasty (TKA). Standard knee anteroposterior radiographs performed within 2 days following surgery were compared to standard knee anteroposterior radiographs taken 1 year following the surgery in patients with well-functioning prosthesis. Tibial prosthesis alignment angles between the longitude of the tibial shaft and the tibial baseplate were calculated using Centricity Enterprise Web V3.0 software. The data was examined using R software. In well-functioning primary knee arthroplasties, tibial prosthesis alignment angles measured in the 1-year follow-up standard view knee radiographs were found to deviate from measurements obtained with the same radiographic specifications in the immediate post-operative period. A significant mean percentage difference was found between the two radiographs. Long knee view radiographs may be required in order to accurately assess tibial prothesis alignment following total knee arthroplasty


Bone & Joint Research
Vol. 9, Issue 4 | Pages 162 - 172
1 Apr 2020
Xie S Conlisk N Hamilton D Scott C Burnett R Pankaj P

Aims

Metaphyseal tritanium cones can be used to manage the tibial bone loss commonly encountered at revision total knee arthroplasty (rTKA). Tibial stems provide additional fixation and are generally used in combination with cones. The aim of this study was to examine the role of the stems in the overall stability of tibial implants when metaphyseal cones are used for rTKA.

Methods

This computational study investigates whether stems are required to augment metaphyseal cones at rTKA. Three cemented stem scenarios (no stem, 50 mm stem, and 100 mm stem) were investigated with 10 mm-deep uncontained posterior and medial tibial defects using four loading scenarios designed to mimic activities of daily living.


Objectives

Preservation of both anterior and posterior cruciate ligaments in total knee arthroplasty (TKA) can lead to near-normal post-operative joint mechanics and improved knee function. We hypothesised that a patient-specific bicruciate-retaining prosthesis preserves near-normal kinematics better than standard off-the-shelf posterior cruciate-retaining and bicruciate-retaining prostheses in TKA.

Methods

We developed the validated models to evaluate the post-operative kinematics in patient-specific bicruciate-retaining, standard off-the-shelf bicruciate-retaining and posterior cruciate-retaining TKA under gait and deep knee bend loading conditions using numerical simulation.