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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 4th 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].


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 24 - 24
1 Apr 2019
Hettich G Schierjott RA Schilling C Maas A Ramm H Bindernagel M Lamecker H Grupp TM
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Introduction

Acetabular bone defects are still challenging to quantify. Numerous classification schemes have been proposed to categorize the diverse kinds of defects. However, these classification schemes are mainly descriptive and hence it remains difficult to apply them in pre-clinical testing, implant development and pre-operative planning. By reconstructing the native situation of a defect pelvis using a Statistical Shape Model (SSM), a more quantitative analysis of the bone defects could be performed. The aim of this study is to develop such a SSM and to validate its accuracy using relevant clinical scenarios and parameters.

Methods

An SSM was built on the basis of segmented 66 CT dataset of the pelvis showing no orthopedic pathology. By adjusting the SSM's so called modes of shape variation it is possible to synthetize new 3D pelvis shapes. By fitting the SSM to intact normal parts of an anatomical structure, missing or pathological regions can be extrapolated plausibly.

The validity of the SSM was tested by a Leave-one-out study, whereby one pelvis at a time was removed from the 66 pelvises and was reconstructed using a SSM of the remaining 65 pelvises. The reconstruction accuracy was assessed by comparing each original pelvis with its reconstruction based on the root-mean-square (RMS) surface error and five clinical parameters (center of rotation, acetabulum diameter, inclination, anteversion, and volume). The influence of six different numbers of shape variation modes (reflecting the degrees of freedom of the SSM) and four different mask sizes (reflecting different clinical scenarios) was analyzed.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 128 - 128
1 Apr 2019
Kebbach M Geier A Darowski M Krueger S Schilling C Grupp TM Bader R
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Introduction

Total knee replacement (TKR) is an established and effective surgical procedure in case of advanced osteoarthritis. However, the rate of satisfied patients amounts only to about 75 %. One common cause for unsatisfied patients is the anterior knee pain, which is partially caused by an increase in patellofemoral contact force and abnormal patellar kinematics. Since the malpositioning of the tibial and the femoral component affects the interplay in the patellofemoral joint and therefore contributes to anterior knee pain, we conducted a computational study on a cruciate-retaining (CR) TKR and analysed the effect of isolated femoral and tibial component malalignments on patellofemoral dynamics during a squat motion.

Methods

To analyse different implant configurations, a musculoskeletal multibody model was implemented in the software Simpack V9.7 (Simpack AG, Gilching, Germany) from the SimTK data set (Fregly et al.). The musculoskeletal model comprised relevant ligaments with nonlinear force-strain relation according to Wismans and Hill-type muscles spanning the lower extremity. The experimental data were obtained from one male subject, who received an instrumented CR TKR. Muscle forces were calculated using a variant of the computed muscle control algorithm. To enable roll-glide kinematics, both tibio- and patellofemoral joint compartments were modelled with six degrees of freedom by implementing a polygon-contact-model representing the detailed implant surfaces. Tibiofemoral contact forces were predicted and validated using data from experimental squat trials (SimTK). The validated simulation model has been used as reference configuration corresponding to the optimal surgical technique. In the following, implant configurations, i.e. numerous combinations of relative femoral and tibial component alignment were analysed: malposition of the femoral/tibial component in mediolateral (±3 mm) and anterior-posterior (±3 mm) direction.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 125 - 125
1 Apr 2019
Sanchez E Schilling C Grupp TM Verdonschot N Janssen D
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Introduction

Although cementless press-fit femoral total knee arthroplasty (TKA) components are routinely used in clinical practice, the effect of the interference fit on primary stability is still not well understood. Intuitively, one would expect that a thicker coating and a higher surface roughness lead to a superior fixation. However, during implant insertion, a thicker coating can introduce more damage to the underlying bone, which could adversely influence the primary fixation. Therefore, in the current study, the effect of coating thickness and roughness on primary stability was investigated by measuring the micromotions at the bone-implant interface with experimental testing.

Methods

A previous experimental set-up was used to test 6 pairs of human cadaveric femurs (47–60 years, 5 females) implanted with two femoral component designs with either the standard e.motion (Total Knee System, B. Braun, Germany) interference fit of 350 µm (right femurs) or a novel, thicker interference fit of 700 µm (left femurs). The specimens were placed in a MTS machine (Figure 1) and subjected to the peak loads of normal gait (1960N) and squat (1935N), based on the Orthoload dataset for Average 75.

Varus/valgus moments were incorporated by applying the loads at an offset relative to the center of the implants, leading to a physiological mediolateral load distribution. Under these loads, micromotions at the implant-bone interface were measured using Digital Image Correlation (DIC) at different regions of interest (ROIs – Figure 1). In addition, DIC was used to measure opening and closing of the implant-bone interface in the same ROIs.


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Modular hip prostheses were introduced to optimize the intra-surgical adaptation of the implant design to the native anatomy und biomechanics of the hip. The downside of a modular implant design with an additional modular interface is the potential susceptibility to fretting, crevice corrosion and wear. For testing hip implants with proximal femoral modularity according to ISO & ASTM, sodium chloride solutions are frequently used to determine the fatigue strength and durability of the stem-neck connection. The present study illustrate that the expansion of standard requirements of biomechanical testing is necessary to simulate metal ion release as well as fretting and crevice corrosion by using alternative test fluids. To assess the primary stability of tibial plateaus in vitro, different approaches had been undergone: cement penetration depth analysis, static tension or compression loading until interface failure. However, these test conditions do not reflect the in vivo physiologic loading modes, where the tibial plateau is predominantly subjected to combined compression and shear forces. The objectives were to evaluate the impact of the tibial keel & stem length on the primary stability of a posterior-stabilised tibial plateau under dynamic compression-shear loading conditions in human tibiae.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 48 - 48
1 Apr 2018
Reyna ALP Fritz B Schwiesau J Summer B Thomas P Grupp TM
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Total knee arthroplasty is a well established treatment for degenerative joint disease with good clinical results. However, complications may occur due to a biological response to polyethylene wear particles, leading to osteolysis and aseptic loosening, as well as local and systemic hypersensitivity reactions triggered by metal ions and particles such as chromium, cobalt and molybdenum. Moreover, there is an increasing demand on the performance of these implants, as this treatment is also performed in heavier, younger and middle-aged adults who have a significant physical activity and higher life expectancy. The purpose of the following study was to compare the wear characteristics and performance of a zirconium nitride (ZrN) coated knee implant, designed for patients with metal ion hypersensitivity, against the clinically established cobalt-chromium (CoCr) version under a high demanding activities wear simulation.

Medium size AS Columbus® DD (Aesculap AG, Tuttlingen, Germany) femoral and tibial components with a ZrN surface were tested in comparison with the cobalt-chromium version Columbus® DD. For both groups, ultra-high-molecular weight polyethylene (UHMWPE) gliding surfaces (size T3, high 10 mm) were used. Wear simulation was performed on a load controlled 4 station knee wear simulator (EndoLab GmbH, Thansau, Germany) capable of reproducing loads and movement of daily activities measured in vivo (Bergmann et al, 2014) on 8 patients and normalized to a patient weight of 100 kg (Schwiesau et al, 2014). The load profiles were applied for 5 million cycles in a combination of 40% stairs up, 40% stairs down, 10% level walking, 8% chair raising and 2% deep squatting. Test serum was changed every 0.5 million cycles and all the components were cleaned and analyzed according to ISO 14243-2:2009(E). The gliding surfaces were evaluated for gravimetric wear and wear patterns, femur components analyzed for scratches and the test medium analyzed for metal ion concentration (cobalt, chromium, molybdenum and zirconium) using ICP-MS according to ISO 17294-2.

The present study showed a wear rate reduction for the ZrN group (1.01 ± 0.29 mg/million) in comparison with the CoCr group (2.40 ± 1.18 mg/million cycles). The articulation surface of the ZrN coated femurs remained polished after the testing period, whereas the uncoated femurs showed wear scratches. Furthermore, the metal ion release from the ZrN coated implants was reduced orders of magnitude in comparison with the CoCr implants through the entire test. These results demonstrate the efficiency of ZrN coated knee implants to reduce wear as well as to prevent metal ion release in the knee joint.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 46 - 46
1 Jan 2017
Mulliez M Holderied M Grupp TM
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INTRODUCTION

Highly cross linked polyethylenes (HXPE) have to be treated thermally after irradiation to eliminate residual free radicals. By adding vitamin E in the polyethylene powder a post-irradiation thermal treatment is not necessary.

In this review the correlation between the intrinsic properties and the long-term stability of Vitelene® as a high performance material for artificial hip articulation will be displayed.

MATERIALS & METHODS

Three different types of polyethylene (UHMWPE; GUR1020) were analyzed to compare mechanical properties as well as oxidative stability: PESTD (γ, 30 kGy, N2), HXPEREM (γ, 75 kGy, remelted, EO), Vitelene® (β, 80 kGy, 0.1% Vitamin E, EO).

Artificial aging (ASTM F2003 − 70 °C, O2 at 5 bar) was used to simulate environmental damage. To evaluate the oxidation stability the Oxidation-Induction-Time (OIT) was measured by Differential Scanning Calorimetry (DSC - ASTM D3895) and the Oxidation Index (OI) was determined by Fourier-Transformation-Infrared-Spectroscopy (FTIR - ASTM F2102). The mechanical properties were analyzed by tensile- and impact investigations (ASTM D638 and ISO 11542-2) as well as by Small Punch Testing (SPT - ASTM F2183). The amount of wear was measured gravimetrically (ISO 14242-2).


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 456 - 456
1 Sep 2009
Grupp TM Stulberg SD Kaddick C Maas A Schwiesau J Fritz B Blömer W
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Introduction: Total knee arthroplasty (TKA) has become a successful clinical treatment for patients in regard to relief of pain, correction of deformity and restoration of function with promising long term behaviour [Pradhan et al. 2006].

In TKA the generation of polyethylene wear debris is mainly affected by the factors design of the articulating bearing, contact stresses, kinematics, implant material and surface finish [McEwen et al. 2005].

The objective of our study was to evaluate the in vitro wear behaviour of fixed bearing knee designs in comprehension to the contact mechanics and resultant kinematics for different degrees of congruency.

Material and Methods: Wear simulator testing on 12 TKA devices has been performed according to ISO 14243-1 under load control. The knee replacements were tested in the fixed bearing configurations LC, CR and DD with different degrees of tibio-femoral congruency.

For gravimetric wear assessment the protocol described in ISO 14243-2 has been used, followed by a kinematic analysis of the single test stations.

The articulating contact and subsurface stresses have been investigated in a finite element analysis.

Results: The contact areas are increasing from Search® Evolution LC (144 mm2) to Columbus® CR (235 mm2) and Columbus® DD (279 mm2), whereas the peak surface contact stresses are decreasing from Search® Evolution LC (34.4 MPa) to Columbus® CR (20.9 MPa) and Columbus® DD (18.1 MPa). The estimated amount of wear has decreased from Search® Evolution LC (21.4 mg/million cycles) to Columbus® CR (8.9 mg/million cycles) and Columbus® DD (2.2 mg/million cycles).

The wear rates between the knee design configurations differ substantially and statistically analysis demonstrates a significant difference (p< 0.01) between the test groups in correlation with congruency.

Conclusion: The present study demonstrates the influence of different bearing types on contact stresses, abrasive wear and kinematics for three different degrees of tibio-femoral congruency under elimination of production, material and sterilization parameters.

Corresponding author: Dr.-Ing. Thomas M. Grupp

Research and Development: e-mail: thomas.grupp@aesculap.de