Startseite Wear of a total intervertebral disc prosthesis
Artikel Open Access

Wear of a total intervertebral disc prosthesis

Abrasion tests of a tribological system of total intervertebral disc prosthesis with dampening characteristics
  • Carina Micheler , Erhard Krampe EMAIL logo , Peter Foehr , Miriam Haerst und Rainer Burgkart
Veröffentlicht/Copyright: 30. September 2016
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Abstract

In this study we characterized the wear behavior of a tribological system with material combinations of the total intervertebral disc prosthesis InDisc (Institute of Medical and Polymer Engineering) – consisting of two laser sintered titanium alloy plates with an elastomer inbetween. For the tests a translatory oscillation test bench was used which simulates the kinematic and the physiological environment of the lumbar spine. In the interface between the elastomer (Silopren LSR 2670) and the laser sintered titanium alloy (Ti6Al4V) abrasion cords out of silicone rubber with a maximal area of 500 × 700 μm2 were generated as well as individual particles with a size of 10 × 20 to 40 × 50 μm2. In the second prosthesis interface of Ti6Al4V and bone, bone particles with an area of 0.5 × 0.5 to 1 × 1 μm2 were detected. The wear particles and the amount of wear volume influence the biological response of a total intervertebral disc prosthesis in the body.

1 Introduction

Backache is a widespread disease in Germany [1] mainly caused by degenerative changes of the intervertebral disc and the rise of sedentary activities [2]. Current treatments for backache are medication and conservative physiotherapy or surgical methods [3]. If conservative physiotherapy achieves no pain relief or there is already a herniated disc, surgical treatments will be performed, e.g. cages for fusion or mobility-retaining total intervertebral disc prostheses are implanted. The standard treatment is the fusion of the vertebral segment [4]. Meanwhile a rising number of intervertebral disc prostheses are implanted and therefore it is necessary to follow up the wear behaviour of total intervertebral disc prosthesis since wear particles can result in foreign body reactions and loosening of the implant from the corresponding bone.

2 Methods

2.1 Total intervertebral disc prosthesis

The total intervertebral disc prosthesis InDisc of the Institute of Medical and Polymer Engineering (Figure 1A) for the lumbar disc between the vertebral bodies L4 and L5 consist of two endplates with a porous structure for osseointegration and a flexible silicone (Silopren LSR 2670, Momentive Performance Materials) component, which imitates the dampening characteristics of the anatomical disc. The silicone is a liquid silicone rubber for injection mould purpose and has a hardness of 70 Shore A. The endplates are made of the titanium alloy Ti6Al4V by direct metal laser sintering [5].

Figure 1 Intervertebral disc prosthesis InDisc: (A) CAD-model, (B) Interfaces of InDisc: (1) Ti6Al4V – LSR 2670, (2) Ti6Al4V – vertebral body.
Figure 1

Intervertebral disc prosthesis InDisc: (A) CAD-model, (B) Interfaces of InDisc: (1) Ti6Al4V – LSR 2670, (2) Ti6Al4V – vertebral body.

Due to the ease of accessibility technical silicone was used as in a medical grade silicone, the same abrasion characteristics can be expected.

2.2 Interfaces

The two interfaces of the InDisc prosthesis (Figure 1B) were examined, the titanium alloy Ti6Al4V with a laser sintering respectively rapid prototyping surface (further referred to as “RP”) and the hardened silicone LSR 2670 and the second interface Ti6Al4V with a bone-like porous structure (further referred to as “por”) and the cortical bone of the vertebral body of a bovine cervical spine. Furthermore the friction behaviour between Ti6Al4V RP and bone (cortical and cancellous bone, respectively) were also compared.

2.3 Experimental setup

For the analysis of the wear behaviour a translatory oscillation test bench was used with the test specimens pin and the plate material (Figure 2). The cyclic test applied a shear load to the specimen. This shear load was induced by a predefined normal force (axial compression) that was adjusted via a load cell. To allow an indenter movement along the normal axis a proportional spring was additionally integrated into the loading chain. The wear amplitude in anterior-posterior direction was set by an adjustable eccentric. The test duration was determined by the frequency and the number of loading cycles, which was defined with respect to the material combination (Table 1). To simulate a physiological environment, constructs were placed in a specimen chamber, fully covered with Ringer’s solution and heated up to a temperature of 37°C. All tests were performed at a frequency of 2 Hz, a normal force of 100 N and wear amplitude of 1 mm. [6]

Figure 2 Test bench: (A) experimental setup: (1) predefined normal force, (2) adjustable eccentric, (3) rev counter, (4) axial compensation and bearing, (5) motor and gear, (B) detailed view of the specimen chamber, (C) test specimen.
Figure 2

Test bench: (A) experimental setup: (1) predefined normal force, (2) adjustable eccentric, (3) rev counter, (4) axial compensation and bearing, (5) motor and gear, (B) detailed view of the specimen chamber, (C) test specimen.

Table 1

Results for different loading setups and constructs.

No.ComponentsCyclesWear Vol. (mm3)Wear Rate (mm3/Nm)
1Ti (RP)/LSR 2670750,00014.15931.59E-05
2Ti (RP)/LSR 2670750,00011.50426.59E-05
3Ti (RP)/cortical375,00059.667268.32E-05
4Ti (RP)/cortical375,00066.333301.86E-05
5Ti (por)/cortical125,000
6Ti (por)/cortical125,000
7Ti (RP)/cancellous125,0006.33386.58E-05

Ti, Ti6Al4V; RP, Rapid Prototyping; por, porous topography; Cortical, cortical bone; Cancellous, cancellous bone Loading duration (cycles), wear volume (mm2) and wear rate (mm2/Nm).

2.4 Wear analysis

After the wear simulation tests the topography of the friction partners, the amount of abrasion and the wear particles were analysed (Table 1). The analysis of the topography was performed by using a light microscope with a magnification of 100 to 800-fold.

The amount of abrasion was determined by the weight measurement of the test specimens before and after the simulation with a high-precision scale. However, this method only works with the titanium and silicone specimen, but not with the bone preparations, because the weight components of the bone marrow were extracted by the surrounding medium. This made the weight measurement of the samples obsolete. To measure the weight of the particles using filters is an alternative method to determine the amount of abrasion. The filters are utilized to extract the particles from the Ringer’s solution. However, this method is more imprecise compared to the first method, since particles of the environment are also in the filters. By using reference experiments, a factor can be determined to subtract the extra weight. Since this method is still inaccurate, the determined values are only seen as reference values.

For the characterization of the wear particles sections of the filter paper were examined by scanning electron microscope.

3 Results

3.1 Ti6Al4V and LSR 2670

In the friction tests with Ti6Al4V RP and LSR 2670 an abrasive wear of silicone was generated with the wear rate of 31.59E-05 or 26.59E-05 mm3/Nm. The wear is mainly presented as abrasive cords, which form a clew (Figure 4).

The clews were measured and have an area of approximately 200 × 300 to 500 × 700 μm2. In addition to the abrasion cords individual particles were detected, which have a size range of 10 × 20 up to 40 × 50 μm2. During the experiments the topography of the two test specimens changed. The titanium pins before the tests had a rough surface due to the direct metal laser sintering process and were smoothed by the tribological stress and showed grooves in sliding direction. The silicone surface had the same grooves (Figure 3).

Figure 3 Results Ti6Al4V – LSR 2670: Ti6Al4V surface (A) before and (B) after wear simulation, LSR 2670 surface (C) before and (D) after wear simulation (scale bars represent 50 μm, arrows indicate the sliding direction).
Figure 3

Results Ti6Al4V – LSR 2670: Ti6Al4V surface (A) before and (B) after wear simulation, LSR 2670 surface (C) before and (D) after wear simulation (scale bars represent 50 μm, arrows indicate the sliding direction).

Figure 4 Scanning electron microscopy (SEM) of an abrasion cord to measure the particle size after filtration at different magnitues (A: ×100, B: ×500).
Figure 4

Scanning electron microscopy (SEM) of an abrasion cord to measure the particle size after filtration at different magnitues (A: ×100, B: ×500).

3.2 Ti6Al4V and bone

The combinations of Ti6Al4V RP with cortical and cancellous bone generated bone particles with a size of 0.5 × 0.5 to 1 × 1 μm2 (Figure 6). The titanium pins showed the same topographical change as in the tests with silicone and the bone specimens had grooves in the sliding direction (Figure 5).

Figure 5 Grooves in sliding direction after abrasion tests in (A) Ti6Al4V (×100) and (B) cortical bone (×800) (arrows indicate the sliding direction).
Figure 5

Grooves in sliding direction after abrasion tests in (A) Ti6Al4V (×100) and (B) cortical bone (×800) (arrows indicate the sliding direction).

Figure 6 Covered filter paper with a giant amount of cortical bone-meal (SEM), circles: highlighted individual particles for measurement.
Figure 6

Covered filter paper with a giant amount of cortical bone-meal (SEM), circles: highlighted individual particles for measurement.

The tests with cortical bone had a wear rate of 268.32E-05 or 301.86E-05 mm3/Nm. In contrast the friction pairing with cancellous bone had a lower wear rate of 86.58E-05 mm3/Nm.

In the experiments with the trabecular-like structured Ti6Al4V and cortical bone no correct wear rate could be determined due to the catching of the structure in the cortical bone. Despite that bone particles that were broken out were discovered with the maximum size of 100 × 100 μm2.

4 Discussion

The experiments between Ti6Al4V and silicone have a 4–5 times higher wear rate due to the rapid prototyping surface compared to the literature [5] without a rapid prototyping surface.

The wear tests with cortical bone compared to cancellous bone have approximately a 3-fold wear rate.The higher wear rate can be explained by the higher proportion of bone tissue per volume fraction in the corical bone.

The biological response to wear particles depends on its kind and amount. Macrophages and giant cells in the periprosthetic membrane absorb the non-degradable particles and thus lead to a tissue formation and associated osteolysis, which can initiate aseptic loosening.

Acknowledgement

Special thanks to eos GmbH (Krailling), Momentive Performance Materials (Leverkusen), Dr. Handwerker from Henkel AG & Co. KGaA (Garching), Metzgerei Blösch (Niederraunau) and Dr.-Ing. Obst from the Department of Orthopaedics at Technical University of Munich (Munich).

Author’s Statement

Research funding: This study was co-funded by the German Federal Ministry of Education and Research (BMBF) with grant number 0315577C (Funktionale Qualitätssicherung für regenerative Gewebeersatzmaterialien für Knorpel und Meniskus – QuReGe). Conflict of interest: Authors state no conflict of interest. Material and Methods: Informed consent: Informed consent has been obtained from all individuals included in this study. Ethical approval: The conducted research is not related to either human or animal use.

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Published Online: 2016-9-30
Published in Print: 2016-9-1

©2016 Erhard Krampe et al., licensee De Gruyter.

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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