In Vitro Wear of a Novel Vitamin E Crosslinked Polyethylene Lumbar Total Joint Replacement
Abstract
:1. Introduction
2. Methods
2.1. Standard Wear Testing
2.2. Adverse Abrasive Testing
2.3. Impingement Testing
2.4. Interval Analyses
3. Results
3.1. Standard Wear Testing
3.2. Adverse Abrasive Testing
3.3. Impingement Testing
4. Discussion
5. Conclusions
Author Contributions
Funding
Data Availability Statement
Conflicts of Interest
References
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Test | VE-HXLPE TJR | activL SSED [34] | ProDisc SSED [31] |
---|---|---|---|
Standard Wear Testing | The average mass wear rate up to 10 MC was 1.2 ± 0.5 mg/MC for the superior UHMWPE components and 0.4 ± 0.1 mg/MC for the inferior (CoCr) components. | Average cumulative wear at 10 million cycles was 25.3 mg and the mean wear rate was 2.7 mg/MC. The test setup was unable to create any backside wear of the polyethylene inlay. | The average mass wear rate of the polyethylene insert up to 5.0 MC was 5.4 ± 1.3 mg/MC and 4.8 ± 1.1 mg/MC for the large- and medium-sized devices, respectively. |
Adverse Abrasive Testing | The average mass wear rate up to 5 MC was 1.1 ± 0.6 mg/MC for the superior UHMWPE components and 0.2 ± 0.1 mg/MC for the inferior (CoCr) components. | Not included in SSED. | Not included in SSED. |
Impingement Testing | The average mass wear rate up to 1.0 MC was 1.7 ± 1.1 mg/MC (short) and 3.9 ± 1.1 mg/MC (long) for the superior UHMWPE components and 1.2 ± 0.4 mg/MC (short) and 1.2 ± 0.1 mg/MC (long) for the inferior (CoCr) components. | Impingement behavior of the activL® included contact between the cobalt chromium endplates. Based on gravimetric measurements, the mean total material loss from both endplates was 1.5 ± 0.4 mm3. The UHMWPE inlays gained mass during testing.Volume to mass loss using 8.4 mg/mm3 for density: 12.6 ± 3.4 mg/MC. | Under impingement conditions, the rate of mass loss of the polyethylene insert was less than in the Mode I testing condition. The polyethylene demonstrated impingement on the posterior surface. Characteristic of the contact observed on published retrievals, metal-on-metal contact was observed in the 2 mm offset test group. The maximum mass loss experienced by the metal components was converted to maximum volume losses of 0.6 mm3 and 0.5 mm3 for the inferior and superior components, respectively.Volumes to mass loss using 8.4 mg/mm3 for density: 5.4 mg/MC. |
Authors | Lumbar ADR Design Evaluated | Clean Standard Wear Test Methods | Wear Rate | Notes |
---|---|---|---|---|
Hyde et al. (2017) [36] | CHARITÉ | ISO 18192-1 for 5 MC (“Baseline”), followed by testing a lower cross shear, lower loads, and changes in center of rotation | 14.4 ± 2.1 mm3/MC | Lower cross shear reduced baseline wear by 49% |
Siskey et al. (2016) [27] | CHARITÉ | ISO 18192-1 | 13.8 ± 3.8 mg/MC | Conventional polyethylene cores were reverse engineered and tested with retrieved endplates |
Vicars et al. (2012) [37] | CHARITÉ | ISO 18192-1 for 5 MC (“4DOF”), then 5 MC with additional shear load profile (“5DOF”) | 12.2 ± 1.0 mg/MC for 5 MC standard test (“4DOF”); 22.3 ± 2.0 mg/MC for 5 MC standard test (“5DOF”); | Height loss of polyethylene cores was not sensitive to changes in the standard test method |
Kettler et al. (2012) [38] | ProDisc L | ISO 18192-1 for 6 MC at 1 and 2 Hz | 5.6 ± 2.3 mg/MC at 1 Hz 7.7 ± 1.6 mg/MC at 2 Hz | Authors recommended testing at 1 Hz |
Grupp et al. (2009) [39] | Activ-L | ISO/FDIS18192-1 (2006) for 10 MC followed by ASTM F2423-05 | 2.7 ± 0.3 mg/MC (ISO test method) 0.14 ± 0.06 mg/MC (ASTM 2005 test method) | ASTM 2005 lower wear rate explained by linear wear track |
Serhan et al. (2006) [40] | CHARITÉ | Adaptation of ASTM Draft 2 Protocol | 0.13 mg/MC | Linear wear track explains low wear rate |
Authors | Lumbar TDR Design Evaluated | Test Methods | Wear Rate | Notes |
---|---|---|---|---|
Siskey et al. (2016) [27] | CHARITÉ | Impingement protocols (1 MC) with and without facet engagement developed | −1.0 ± 1.2 mg/MC (wear not detectable due to UHMWPE deformation and mass gain due to fluid adsorption) | Test protocols and impingement scars validated with clinical retrievals |
Grupp et al. (2015) [41] | Activ-L | Four different protocols: flexion, extension, lateral bending, flexion and bending | Flexion: 0.67 mm3/MC Extension: 0.21 mm3/MC Lateral bending: 0.06 mm3/MC Flexion and bending: 1.44 mm3/MC | CoCr-CoCr endplate impingement simulated, validated with clinical retrievals |
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Siskey, R.L.; Yarbrough, R.V.; Spece, H.; Hodges, S.D.; Humphreys, S.C.; Kurtz, S.M. In Vitro Wear of a Novel Vitamin E Crosslinked Polyethylene Lumbar Total Joint Replacement. Bioengineering 2023, 10, 1198. https://doi.org/10.3390/bioengineering10101198
Siskey RL, Yarbrough RV, Spece H, Hodges SD, Humphreys SC, Kurtz SM. In Vitro Wear of a Novel Vitamin E Crosslinked Polyethylene Lumbar Total Joint Replacement. Bioengineering. 2023; 10(10):1198. https://doi.org/10.3390/bioengineering10101198
Chicago/Turabian StyleSiskey, Ryan L., Ronald V. Yarbrough, Hannah Spece, Scott D. Hodges, Steven C. Humphreys, and Steven M. Kurtz. 2023. "In Vitro Wear of a Novel Vitamin E Crosslinked Polyethylene Lumbar Total Joint Replacement" Bioengineering 10, no. 10: 1198. https://doi.org/10.3390/bioengineering10101198