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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

  • André BuschEmail author
  • Marcus Jäger
  • Stefan Klebingat
  • Josef Baghdadi
  • Thilo Flörkemeier
  • Felix Hütter
  • Thomas M. Grupp
  • VITAS-Group
  • Marcel Haversath
Orthopaedic Surgery
  • 3 Downloads

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.

Keywords

Total hip arthroplasty CAD-based wear analysis UHMWPE-XE Particle-induced osteolysis 

Notes

Author contribution

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.

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).

Compliance with ethical standards

Ethics approval and consent to participate

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.

Consent to publish

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

Conflict of interest

The authors declare they have no conflict of interest.

Patient confidentiality

Data were protected according to the U.S. Health Insurance Portability and Accountability Act (HIPAA).

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2020

Authors and Affiliations

  1. 1.Department of Orthopaedics, Trauma and Reconstructive Surgery Marienhospital Mülheim an der RuhrChair of Orthopaedics and Trauma Surgery University of Duisburg–EssenEssenGermany
  2. 2.Institut für Medizintechnik und Forschungscampus STIMULATEOtto-von-Guericke-Universität MagdeburgMagdeburgGermany
  3. 3.Department of Orthopaedic SurgeryHannover Medical SchoolHannoverGermany
  4. 4.Department für Orthopädie, Unfall- und WiederherstellungschirurgieUniversitätsklinikum Halle (Saale)Halle (Saale)Germany
  5. 5.Department of Orthopaedics and Trauma SurgeryElisabeth-Klinikum OlsbergOlsbergGermany
  6. 6.Aesculap AG, Research and DevelopmentTuttlingenGermany
  7. 7.Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Campus GrosshadernLudwig Maximilians University MunichMunichGermany

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