Vitamin E-diffused liners show less head penetration than cross-linked polyethylene liners in total hip arthroplasty: a ten-year multi-arm randomized trial

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Aims
The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA).

Methods
A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size.

Results
A total of 116 patients participated, of whom 77 were male. The median ages of the vE-PE 32 mm and 36 mm groups were 65 (interquartile range (IQR) 57 to 67) and 63 years (IQR 56 to 66), respectively, and of the XLPE 32 mm and 36 mm groups were 64 (IQR 58 to 66) and 61 years (IQR 54 to 66), respectively. Mean total head penetration was significantly lower into vE-PE acetabular liner groups than into XLPE acetabular liner groups (-0.219 mm (95% confidence interval -0.348 to -0.090); p = 0.001). There were no differences in wear according to head size, acetabular component migration, or PROMs, except for UCLA. There were no cases of aseptic loosening or failures requiring revision at long-term follow-up.

Conclusion
Significantly lower wear was observed in vE-PE acetabular liners than in XLPE acetabular liners. No difference in wear was observed between different head size or PROMs except for the UCLA at ten years.
OriginalsprogEngelsk
TidsskriftBone and Joint Journal
Vol/bind105 B
Udgave nummer10
Sider (fra-til)1052-1059
Antal sider8
ISSN2049-4394
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
The authors disclose receipt of the following financial or material support for the research, authorship, and/or publication of this article: a grant from Zimmer Biomet covered the cost of study materials and a research nurse, moreover the role of the Funder/Sponsor had the rights to comment on the manuscript but with no changes. We thank Annie Gam-Pedersen, the project nurse, for her essential role in patient recruitment. We also extend our appreciation to statisticians Frank Sjøberg Kjeldsen and Sören Möller from Open Patient data Explorative Network (OPEN), Odense University Hospital (OUH), for their invaluable assistance with statistical analyses. Special thanks to medical student David Karimi from SDU for his help with data collection. Their contributions were vital to the successful completion of this study.

Publisher Copyright:
© 2023 El-Sahoury et al.

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