Christoph Schilling

Biotribology of a new bearing material combination in a rotating hinge knee articulation

The objective of the present study was to evaluate the biotribological behaviour, in terms of wear and particle release, of bushings and flanges made of carbon fibre reinforced poly-ether-ether-ketone (CFR-PEEK) in articulation with a zirconium nitride (ZrN) multilayer surface coating in a rotating hinge knee system. For the bushings of the rotational and flexion axles and the medial and lateral flanges, a CFR-PEEK with 30% polyacrylonitrile fibre content was used in a new bearing combination with ZrN. In vitro wear simulation was performed for patients with metal ion hypersensitivity, using a new rotating hinge knee design with a ZrN surface articulation in comparison with the clinically established cobalt-chromium version. For the bushings and flanges made of CFR-PEEK subjected to wear simulation, the volumetric wear rates were 2.3±0.48mm(3)million(-1) cycles in articulation to cobalt-chromium as reference and 0.21±0.02mm(3)million(-1) cycles in the coupling with ZrN, a 10.9-fold decrease. The released CFR-PEEK particles were comparable in size and shape for the coupling to cobalt-chromium and ZrN with most of the particles in a size range between 0.1 and 2μm. The study reveals comparable low wear and no macroscopic surface fatigue in a new rotating hinge knee design with highly congruent flanges and axles bushings made of CFR-PEEK articulating to a ZrN multilayer surface coating. Favourable wear behaviour of the newly introduced CFR-PEEK/ZrN coupling in comparison with the clinically established CFR-PEEK/cobalt-chromium articulation was found.

Effect of anterior–posterior and internal–external motion restraint during knee wear simulation on a posterior stabilised knee design

The objective of our study was to examine the effect of biphaseal AP translation and IE rotation restraint, using a system defined specifically for posterior stabilised knee designs, on wear, kinematics and particle release in comparison to linear motion restraint as required by the established ISO 14243-1:2002(E) protocol. In the ISOlinear groups, an AP motion restraint of 30 N/mm and an IE rotation restraint of 0.6 Nm/° were applied in the knee wear simulation. In the ISOgap biphaseal groups with PCL sacrificing implants, the restraining AP force was zero in a ±2.5mm range with, externally, a constant of 9.3N/mm applied proportionally to the AP translation of the tibia plateau, whereas the restraining IE torque was zero in a ±6° range with, externally, a constant of 0.13 Nm/° applied proportionally to the IE rotation of the tibia plateau. Using the ISOgap biphaseal protocol on a posterior stabilised knee design, we found an increase of 41% in AP translation and of 131% in IE rotation, resulting in a 3.2-fold higher wear rate compared to the results obtained using the ISOlinear protocol. Changes in AP translation and IE rotation ligament motion restraints have a high impact on knee joint kinematics and wear behaviour of a fixed bearing posterior stabilised knee design.

Fluid-flow dependent response of intervertebral discs under cyclic loading: On the role of specimen preparation and preconditioning

In vivo during the day, intervertebral discs are loaded mainly in compression causing fluid and height losses that are subsequently fully recovered overnight due to fluid inflow under smaller compression. However, in vitro, fluid flow through the endplates, in particular fluid imbibition, is hampered possibly by blood clots formed post mortem. Despite earlier in vitro studies, it remains yet unclear if and how fluid flow conditions in vitro could properly emulate those in vivo. Effects of various preload magnitudes (no preload, 0.06 and 0.28 MPa) and disc-bone preparation conditions (e.g., w/o bony endplates) on disc height and nucleus pressure were investigated using 54 bovine specimens. Changes in specimen height and pressure at different nucleus locations were used as surrogate measures to assess the fluid content and flow within the discs. Under all investigated preparation conditions and preload magnitudes, no significant pressure recovery could be obtained during low loading phases, even without bony endplates. On the contrary, partial to full displacement recovery were reached in particular under 0.28 MPa preload. Results highlight the significant role of disc preload magnitude in disc height recovery during low loading periods. Attention should hence be given in future studies to the proper selection of preload magnitude and duration as well as the animal models used if in vivo response is intended to be replicated. Findings also indicate that flushing the endplates or injection of bone cement respectively neither facilitates nor impedes fluid flow into or out of the disc to a noticeable degree in this bovine disc model.

Preload substantially influences the intervertebral disc stiffness in loading-unloading cycles of compression.

Disc hydration is controlled by fluid imbibition and exudation and hence by applied load magnitude and history, internal osmotic pressure and disc conditions. It affects both the internal load distribution and external load-bearing of a disc while variations therein give rise to the disc time-dependent characteristics. This study aimed to evaluate the effect of changes in compression preload magnitude on the disc axial cyclic compression stiffness under physiological loading. After 20h of free hydration, effects of various preload magnitudes (no preload, 0.06 and 0.28MPa, applied for eight hours) and disc-bone preparation conditions on disc height and axial stiffness were investigated using 36 disc-bone and 24 isolated disc (without bony endplates) bovine specimens. After preloading, specimens were subjected to ten loading/unloading cycles each of 7.5min compression at 0.5MPa followed by 7.5min at 0.06MPa. Under 0.06MPa preload, the specimen height losses during high loading periods of cyclic loading were greater than corresponding height recoveries during low loading phases. This resulted in a progressive reduction in the specimen height and increase in its stiffness. Differences between disc height losses in high cyclic loads and between stiffness in both load increase and release phases were significant for 0 and 0.06MPa vs. 0.28MPa preload. Results highlight the significant role of disc preload magnitude/history and hence disc height and hydration on disc stiffness in loading/unloading and disc height loss in loading periods. Proper preconditioning and hence hydration level should be achieved if recovery in height loss similar to in vivo conditions is expected.

Vitamin E stabilised polyethylene for total knee arthroplasty evaluated under highly demanding activities wear simulation

As total knee arthroplasty (TKA) patients are getting more active, heavier and younger and structural material fatigue and delamination of tibial inserts becomes more likely in the second decade of good clinical performance it appears desirable to establish advanced pre-clinical test methods better characterizing the longterm clinical material behaviour. The questions of our study were 1) Is it possible to induce subsurface delamination and striated pattern wear on standard polyethylene TKA gliding surfaces? 2) Can we distinguish between γ-inert standard polyethylene (PEstand.30kGy) as clinical reference and vitamin E stabilised materials (PEVit.E30kGy & PEVit.E50kGy)? 3) Is there an influence of the irradiation dose (30vs 50kGy) on oxidation and wear behaviour? Clinical relevant artificial ageing (ASTM F2003; 2weeks) of polyethylene CR fixed TKA inserts and oxidation index measurements were performed by Fourier transform infrared spectroscopy prior testing. The oxidation index was calculated in accordance with ISO 5834-4:2005 from the area ratio of the carbonyl peak (between 1650 and 1850cm-1) to the reference peak for polyethylene (1370cm-1). Highly demanding patient activities (HDA) measured in vivo were applied for 5million knee wear cycles in a combination of 40% stairs up, 40% stairs down, 10% level walking, 8% chair raising and 2% deep squatting with up to 100° flexion. After 3.0mc all standard polyethylene gliding surfaces developed noticeable areas of progressive delamination. Cumulative gravimetric wear was 355.9mg for PEstand.30kGy, 28.7mg for PEVit.E30kGy and 26.5mg for PEVit.E50kGy in HDA knee wear simulation. Wear rates were 12.4mg/mc for PEstand.30kGy in the linear portion (0-2mc), 5.6mg/mc for PEVit.E30kGy and 5.3mg/mc for PEVit.E50kGy. In conclusion, artificial ageing of standard polyethylene to an oxidation index of 0.7-0.95 in combination with HDA knee wear simulation, is able to create subsurface delamination, structural material fatigue in vitro, whereas for the vitamin-E-blended materials no evidence of progressive wear, fatigue or delamination was found. STATEMENT OF SIGNIFICANCE As total knee arthroplasty patients are getting more active, heavier and younger and structural material fatigue and delamination of polyethylene tibial inserts becomes more likely in the second decade of good clinical performance, it appears desirable to establish advanced pre-clinical test methods better characterizing the longterm clinical material behaviour. Various studies reported in literature attempted to artificially create delamination during in vitro knee wear simulation. We combined artificial ageing to clinically observed oxidation of gamma inert and vitamin E stabilised polyethylene inserts and highly demanding patient activities knee wear simulation based on in vivo load data. With this new method we were able to create clinically relevant subsurface delamination and structural material fatigue on standard polyethylene inserts in vitro.

Primary stability of tibial plateaus under dynamic compression-shear loading in human tibiae – Influence of keel length, cementation area and tibial stem

The objective of our study was to evaluate the impact of the tibial keel & stem length in surface cementation, of a full cemented keel and of an additional tibial stem on the primary stability of a posterior stabilised tibial plateau (VEGA® System Aesculap Tuttlingen, Germany) under dynamic compression-shear loading conditions in human tibiae. We performed the cemented tibial plateau implantations on 24 fresh-frozen human tibiae of a mean donor age of 70.7years (range 47-97). The tibiae were divided into four groups of matched pairs based on comparable trabecular bone mineral density. To assess the primary stability under dynamic compression shear conditions, a 3D migration analysis of the tibial component relative to the bone based on displacements and deformations and an evaluation of the cement layer including penetration was performed by CT-based 3D segmentation. Within the tested implant fixation principles the mean load to failure of a 28mm keel and a 12mm stem (40mm) was 4700±1149N and of a 28mm keel length was 4560±1429N (p=0.996), whereas the mean load to failure was 4920±691N in full cementation (p=0.986) and 5580±502N with additional stem (p=0.537), with no significant differences regarding the dynamic primary stability under dynamic compression-shear test conditions. From our observations, we conclude that there is no significant difference between a 40mm and a 28mm tibial keel & stem length and also between a surface and a full cementation in the effect on the primary stability of a posterior stabilised tibial plateau, in terms of failure load, migration characteristics and cement layer thickness including the penetration into the trabecular bone.

Backside Wear Analysis of Retrieved Acetabular Liners with a Press-Fit Locking Mechanism in Comparison to Wear Simulation In Vitro

Backside wear due to micromotion and poor conformity between the liner and its titanium alloy shell may contribute to the high rates of retroacetabular osteolysis and consequent aseptic loosening. The purpose of our study was to understand the wear process on the backside of polyethylene liners from two acetabular cup systems, whose locking mechanism is based on a press-fit cone in combination with a rough titanium conical inner surface on the fixation area. A direct comparison between in vitro wear simulator tests (equivalent to 3 years of use) and retrieved liners (average 13.1 months in situ) was done in order to evaluate the backside wear characteristics and behavior of these systems. Similar wear scores between in vitro tested and retrieved liners were observed. The results showed that this locking mechanism did not significantly produce wear marks at the backside of the polyethylene liners due to micromotion. In all the analyzed liners, the most common wear modes observed were small scratches at the cranial fixation zone directly below the rough titanium inner surface of the shell. It was concluded that most of the wear marks were produced during the insertion and removal of the liner, rather than during its time in situ.

Metal ion release barrier function and biotribological evaluation of a zirconium nitride multilayer coated knee implant under highly demanding activities wear simulation

Total knee arthroplasty is a well established treatment for degenerative joint disease, which is also performed as a treatment in younger and middle-aged patients who have a significant physical activity and high life expectancy. However, complications may occur due to biological responses to wear particles, as well as local and systemic hypersensitivity reactions triggered by metal ions and particles such as cobalt, chromium and molybdenum. The purpose of the study was to perform a highly demanding activities (HDA) knee wear simulation in order to compare the wear characteristics and metal ion release barrier function of a zirconium nitride (ZrN) coated knee implant, designed for patients with suspected metal ion hypersensitivity, against an uncoated knee implant made out of CoCrMo. The load profiles were applied for 5 million HDA cycles, which represent 15-30 years of in vivo service depending on the activity level of the patient. Results showed a significant wear rate reduction for the coated group (1.01 ± 0.29 mg/million cycles) in comparison with the uncoated group (2.89 ± 1.04 mg/million cycles). The zirconium nitride coating showed no sign of scratches nor delamination during the wear simulation, whereas the uncoated femurs showed characteristic wear scratches in the articulation areas. Furthermore, the metal ion release from the coated implants was reduced up to three orders of magnitude in comparison with the uncoated implants. These results demonstrate the efficiency of zirconium nitride coated knee implants to reduce wear as well as to substantially reduce metal ion release in the knee joint.

Primary stability of unicompartmental knee arthroplasty under dynamic flexion movement in human femora

Background: The objective of our study was to evaluate the impact of a trabecular stem fixation versus a cortical teeth fixation technique on the primary stability of cemented unicompartmental femoral components under dynamic flexion movement loading conditions in human femora. Methods: Ten fresh‐frozen human knees of a mean donor age of 73.9 years were used to perform medial unicompartmental knee arthroplasty under a less invasive parapatellar surgical approach. The femora were divided into two groups of matched pairs based on comparable trabecular bone mineral density. To assess the primary stability, a new method based on a combination of dynamic flexion movement, double‐peak loading simulating stair climbing, kinematic analysis of the femoral component migration relative to the bone and an evaluation of the cement layer by fragments cut through the implant‐cement‐bone interface in the sagittal plane of the medial condyle was introduced. Findings: For the “trabecular stem fixation” technique the mean load to failure was 2340 (SD 650) N and for “cortical teeth fixation” it was 1080 (SD 455) N, with a substantially enhanced dynamic fixation strength for the “trabecular stem fixation” (p = 0.008). In the distal area the cement layer of the “trabecular stem fixation” showed a significant decreased thickness compared to the “cortical teeth fixation” (p = 0.029), while a substantially deeper cement penetration (p = 0.044) has been achieved for the “trabecular stem fixation”. Interpretation: From our observations, we conclude that there is a significantly enhanced primary stability with a “trabecular stem fixation” compared to a “cortical teeth fixation” technique of cemented unicompartmental femoral components, in terms of dynamic failure load and migration characteristics. HighlightsHuman knees were used for medial UKA in a less invasive parapatellar approach.Primary stability was evaluated for a trabecular stem vs a cortical teeth fixation.Dynamic flexion & double‐peak loading simulating stair climbing was applied.A 3D displacement & migration analysis of the femoral implant to the bone was used.An increased primary stability of the trabecular stem fixation was found.