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
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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.
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).
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)].
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.
KeywordsTotal hip arthroplasty CAD-based wear analysis UHMWPE-XE Particle-induced osteolysis
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.
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.
Data were protected according to the U.S. Health Insurance Portability and Accountability Act (HIPAA).
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