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Vitamin E-blended highly cross-linked polyethylene liners in total hip arthroplasty: a randomized, multicenter trial using virtual CAD-based wear analysis at 5-year follow-up

  • Orthopaedic Surgery
  • Published:
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Abstract

Background

Progressive oxidation of highly cross-linked ultra-high molecular weight (UHMPWE-X) liners is considered to be a risk factor for material failure in THA. Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE) were supplemented into the latest generation of polyethylene liners. To prevent inhomogenous vitamin E distribution within the polymer, blending was established as an alternative manufacturing process to diffusion. The purpose of the present study was to investigate the in vivo wear behavior of UHMWPE-XE in comparison with conventional UHMWPE-X liners using virtual CAD-based radiographs.

Methods

Until now, 94 patients from a prospective, randomized, controlled, multicenter study were reviewed at 5-year follow-up. Of these, 51 (54%) received UHMWPE-XE and 43 (46%) UHMWPE-X liners. Anteroposterior pelvic radiographs were made immediately after surgery and at 1 and 5 years postoperatively. The radiographs were analyzed using the observer-independent analysis software RayMatch® (Raylytic GmbH, Leipzig, Germany).

Results

The mean wear rate was measured to be 23.6 μm/year (SD 13.7; range 0.7–71.8 μm). There were no significant differences between the two cohorts (UHMWPE-X: 23.2 μm/year vs. UHMWPE-XE: 24.0 μm/year, p = 0.73). Cup anteversion significantly changed within the 1st year after implantation independent from the type of polyethylene liner [UHMWPE-X: 18.2–23.9° (p = 0.0001); UHMWPE-XE: 21.0–25.5° (p = 0.002)]. No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)].

Conclusion

The present study demonstrates that the addition of vitamin E does not adversely affect the midterm wear behavior of UHMWPE-X. The antioxidative benefit of vitamin E is expected to become evident in long-term follow-up. Cup anteversion increment by 5° within the 1st year is likely a result of the released hip flexion contracture resulting in an enhanced posterior pelvic tilt. Therefore, a reassessment of target values in acetabular cup placement might be considered.

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Availability of data and materials

All patient-related data were collected by file research from the archives of the participating centers.

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Funding

The study is financially supported by B. Braun-Aesculap AG, Germany; Trial registration: NCT01713062. This study was supported by B. Braun Melsungen (AAG-G-H-1113).

Author information

Author notes

  1. André Busch and Marcus Jäger equally contributed to the article.

Authors and Affiliations

  1. Department of Orthopaedics, Trauma and Reconstructive Surgery Marienhospital Mülheim an der Ruhr, Chair of Orthopaedics and Trauma Surgery University of Duisburg–Essen, Essen, Germany

    André Busch, Marcus Jäger & Marcel Haversath

  2. Institut für Medizintechnik und Forschungscampus STIMULATE, Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany

    Stefan Klebingat

  3. Department of Orthopaedic Surgery, Hannover Medical School, Hannover, Germany

    Josef Baghdadi

  4. Department für Orthopädie, Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Halle (Saale), Ernst-Grube-Str. 40, 06114, Halle (Saale), Germany

    Thilo Flörkemeier

  5. Department of Orthopaedics and Trauma Surgery, Elisabeth-Klinikum Olsberg, Olsberg, Germany

    Felix Hütter

  6. Aesculap AG, Research and Development, 78532, Tuttlingen, Germany

    Thomas M. Grupp

  7. Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Campus Grosshadern, Ludwig Maximilians University Munich, Munich, Germany

    Thomas M. Grupp

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All authors ensured that they had furnished a substantial contribution to the article and that they are in agreement with form and contents of the manuscript.

Corresponding author

Correspondence to André Busch.

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The study was approved by the local ethics committee (11-4845-BO). The study was registered on Clinicaltrials.gov. The trial registration number is NCT01713062.

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All patients consented to publish personal data in an anonymised form.

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Busch, A., Jäger, M., Klebingat, S. et al. Vitamin E-blended highly cross-linked polyethylene liners in total hip arthroplasty: a randomized, multicenter trial using virtual CAD-based wear analysis at 5-year follow-up. Arch Orthop Trauma Surg 140, 1859–1866 (2020). https://doi.org/10.1007/s00402-020-03358-x

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