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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 52 - 52
1 Mar 2021
Harris A O'Grady C Sensiba P Vandenneucker H Huang B Cates H Christen B Hur J Marra D Malcorps J Kopjar B
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Patients ≤ 55 years have a high primary TKA revision rate compared to patients >55 years. Guided motion knee devices are commonly used in younger patients yet outcomes remain unknown. In this sub-group analysis of a large multicenter study, 254 TKAs with a second-generation guided motion knee implant were performed between 2011–2017 in 202 patients ≤ 55 years at seven US and three European sites. Revision rates were compared with Australian Joint Registry (AOANJRR) 2017 data. Average age 49.7 (range 18–54); 56.4% females; average BMI 34 kg/m2; 67.1% obese; patellae resurfaced in 98.4%. Average follow-up 4.2 years; longest follow-up six years; 27.5% followed-up for ≥ five years. Of eight revisions: total revision (one), tibial plate replacements (three), tibial insert exchanges (four). One tibial plate revision re-revised to total revision. Revision indications were mechanical loosening (n=2), infection (n=3), peri-prosthetic fracture (n=1), and instability (n=2). The Kaplan-Meier revision estimate was 3.4% (95% C.I. 1.7% to 6.7%) at five years compared to AOANJRR rate of 6.9%. There was no differential risk by sex. The revision rate of the second-generation guided motion knee system is lower in younger patients compared to registry controls


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 154 - 154
1 Jul 2014
Kurtz S Zielinska O MacDonald D Cates H Mont M Malkani A Parvizi J Kraay M Rimnac C Klein G
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Summary Statement. This study assesses oxidation, mechanical behavior and revision reasons of 2. nd. generation HXLPE used in total hip and knee arthroplasty. While oxidation was low for both X3 and E1 HXLPEs, oxidative regional variations were detected in the sequentially annealed cohort. Introduction. First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1. st. generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2. nd. generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2. nd. generation HLXPEs. The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA. Methods. 251 2. nd. Generation HXLPE hip and knee components were consecutively retrieved during revision surgeries and continuously analyzed in a prospective, IRB approved, multicenter study. 123 acetabular liners (Implanted 1.2y; Range 0–5.0y) and 117 tibial inserts (Implanted 1.6y; Range 0–5.8y) were highly crosslinked and annealed in 3 sequential steps (X3). Five acetabular liners (Implanted 0.6y; Range 0–2.0y) and six tibial inserts (Implanted 1.3y; Range 0.5–1.8y) were diffused with Vitamin E (E1). Patient information was collected from medical records. Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Surface damage of tibial components was assessed using the Hood method. Thin sections were taken from the acetabular liners (along the superior/inferior axis) and the tibial components (along the medial condyle and central spine) for oxidation analysis and analyzed according to ASTM 2102. Mechanical behavior was assessed via the small punch test (ASTM 2183). Results. The liners and tibial components fabricated from both HXLPEs were revised predominantly for loosening, instability, and infection. The average penetration rate for the Sequentially Annealed group was low (PR=0.045mm/yr). Pitting, scratching and burnishing were the predominant damage mechanisms of the tibial inserts within both material groups, with no evidence of delamination. Oxidation indices were low (Mean OI≤0.3) and similar between liners and inserts of the Sequentially Annealed components at the bearing and backside surface (p≥0.15). Oxidation was positively correlated with implantation time at the bearing surface of the Sequentially Annealed groups (Rho>0.29, p<0.005). The Ultimate Load of the Sequentially Annealed acetabular liners was statistically higher than the tibial components (p<0.001), however the mean difference was minimal (∼6N). Discussion. This study evaluated the properties of 2. nd. generation HXLPEs used in THA and TKA. Sequentially Annealed liners had penetration rates comparable with 1. st. generation HXLPEs. While oxidation was low for both sequentially annealed and Vitamin E HXLPEs, we were able to detect regional variations in the oxidative in the sequentially annealed cohort. Longer-term retrievals are necessary to fully assess the oxidative stability of Vitamin E diffused HXLPE used in TKA and THA


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. 96-B, Issue SUPP_11 | Pages 167 - 167
1 Jul 2014
Iwamoto K Tomita T Yamazaki T Sasaki A Kii Y Futai K Miyamoto T Fujii M Yoshikawa H Sugamoto K
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Summary. The effect of the geometry of the tibial polyethylene insert was investigated in vivo loaded conditions. Introduction. The decision to choose CR (cruciate retaining) insert or CS (condylar stabilised) insert during TKA remains a controversial issue. Triathlon CS type has a condylar stabilised insert with an increased anterior lip that can be used in cases where the PCL is sacrificed but a PS insert is not used. The difference of the knee kinematics between CR and CS insert remains unclear. This study measured knee kinematics of deep knee flexion under load in two insert designs using 2D/3D registration technique. Patients and Methods. We investigated the in vivo knee kinematics of 20 knees (18 patients) implanted with Triathlon CR components (Stryker Orthopedics, Mahwah, NJ), 10 knees in the CR insert with retaining PCL, and 10 knees in the CS insert with sacrificing PCL. All TKAs were judged clinically successful (Knee Society knee scores >90), with no ligamentous laxity or pain. Mean patient age at the time of operation was 72±12 years in CR and 69±9 years in CS. Mean period between operation and surveillance was 20±11 months in CR and 11±5 months in CS. Under fluoroscopic surveillance, each patient did a wight-bearing deep knee bending motion. Femorotibial motion including tibial polyethylene insert was analyzed using 2D/3D registration technique, which uses computer-assisted design (CAD) models to reproduce the spatial position of the femoral, tibial components from single-view fluoroscopic images. We evaluated the range of motion, femoral axial rotation, and antero-posterior (AP) translation of the nearest points. Results. The average range of motion between femoral component and tibial component was 113.3±22.3° in CR and 107.4±13.1° in CS. The amount of femoral axial rotation from 0° to 110° flexion was 8.6±2.9° in CR insert, and 7.6±2.6° in CS insert, respectively. No significant difference was observed in the amount of femoral external rotation (p=0.71). In CR insert, the medial contact point moved 4.0±2.9mm anteriorly from 0° to 100° flexion. The lateral contact point moved 2.0±1.1mm anteriorly from 60° to 90° flexion. In CS insert, the medial contact point moved 6.4±2.1mm anteriorly from 20° to 100° flexion. The lateral contact point moved 1.9±1.7mm anteriorly from 50° to 110° flexion. There was significant differences were observed in the amount of medial anterior translation between the two insert (medial; p=0.04, lateral; p=0.94). Discussion and Conclusion. Triathlon CR and CS insert had a similar kinematics pattern. However, there was significant differences were observed in the amount of medial anterior translation between the two insert. These results indicated that the increased anterior lip could not control medial anterior sliding. The posterior part of the two insert were almost same, so the kinematics are similar


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.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 11 | Pages 1528 - 1533
1 Nov 2007
Jeffcote B Nicholls R Schirm A Kuster MS

Achieving deep flexion after total knee replacement remains a challenge. In this study we compared the soft-tissue tension and tibiofemoral force in a mobile-bearing posterior cruciate ligament-sacrificing total knee replacement, using equal flexion and extension gaps, and with the gaps increased by 2 mm each. The tests were conducted during passive movement in five cadaver knees, and measurements of strain were made simultaneously in the collateral ligaments. The tibiofemoral force was measured using a customised mini-force plate in the tibial tray. Measurements of collateral ligament strain were not very sensitive to changes in the gap ratio, but tibiofemoral force measurements were. Tibiofemoral force was decreased by a mean of 40% (sd 10.7) after 90° of knee flexion when the flexion gap was increased by 2 mm. Increasing the extension gap by 2 mm affected the force only in full extension. Because increasing the range of flexion after total knee replacement beyond 110° is a widely-held goal, small increases in the flexion gap warrant further investigation.