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Vitamin E-blended versus conventional polyethylene liners in prostheses

Prospective, randomized trial with 3-year follow-up

Vitamin-E-vermischte vs. konventionelle Polyethyleninlays in der Prothetik

Prospektive, randomisierte Studie mit 3-Jahres-Follow-up

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Abstract

Background

Despite continuous technical improvements, polyethylene wear debris induced periprosthetic osteolysis remains the main cause for failure of hip arthroplasty. Progressive oxidation of polyethylene was identified as another risk factor for material failure. To overcome this problem, antioxidants such as vitamin E (alpha-tocopherol) were supplemented by diffusion into the latest generation of polyethylene liners.

Objective

The purpose of the present study was to investigate the clinical outcome of patients treated with vitamin E blended highly cross-linked ultra-high molecular weight polyethylene liners (UHMWPE-XE) in comparison with conventional UHMWPE‑X liners by evaluating patient-reported outcome measures (PROM’s) at 3‑year follow-up.

Methods

A total of 143 patients were recruited into this prospective, randomized trial in our academic center. Three years after implantation, 101 patients were examined in the outpatient clinic for follow-up. Of these, 51 (50.5%) received UHMWPE-XE and 50 (49.5%) UHMWPE‑X liners. Clinical outcome was evaluated using Harris-Hip-Score (HHS) UCLA-Score and Hip Disability and Osteoarthritis Outcome Score (HOOS).

Results

There was a significant improvement in all PROM’s at one- and three-year follow-up compared to the status before implantation. PROM’s did not differ significantly between the first and third year follow-up. Both liner groups showed an equal clinical outcome.

Conclusion

The present study demonstrates that the supplementation of vitamin E to polyethylene liners is reliable and safe without showing higher complication rates compared with conventional polyethylene liners. The shortterm clinical outcome of vitamin E-blended (UHMWPE‑XE) is equivalent to those of conventional highly cross-linked polyethylene liners.

Zusammenfassung

Hintergrund

Trotz der stetigen Verbesserung der Materialeigenschaften bleibt die durch Abriebpartikel von Polyethylen im periprothetischen Gewebe induzierte aseptische Inflammation mit Osteoklastenaktivierung und aseptischer Prothesenlockerung eine der Hauptkomplikationen in der Hüftendoprothetik. Als weitere Gründe für den Materialverschleiß von Polyethylen wurden Oxidationsprozesse identifiziert. Zur Überwindung dieser Problematik, werden seit einigen Jahren hochvernetzte Polyethylen-Inlays hergestellt, die mit dem Antioxidans Tocopherol (Vitamin E) vorbehandelt werden. Das Ziel dieser Studie war es, die klinischen Ergebnisse von Patienten, denen Vitamin E “blended” bzw. konventionelle Polyethylen-Inlays in der Hüftendoprothetik implantiert wurden, anhand von PROM’s (patient related outcome measurements) zu bewerten.

Methoden

In unserem Zentrum wurden insgesamt 143 Patienten in diese prospektive, randomisierte Studie eingeschlossen. Zur 3‑Jahresnachuntersuchung kamen insgesamt 101 Patienten, von denen 51 ein Vitamin E vermischtes (50,5%) und 50 ein konventionelles (49,5%) Polyethylen-Inlay erhielten. Das klinische Ergebnis wurde anhand von Harris-Hip-Score (HHS) UCLA-Score und Hip Disability und Osteoarthritis Outcome Score (HOOS) bewertet.

Ergebnis

Es zeigte eine signifikante Verbesserung von allen PROM’s bei der 1-Jahresnachuntersuchung im Vergleich zum präoperativen Befund in beiden Kohorten. Die Ergebnisse verblieben auf hohem Niveau bei der 3-Jahresnachuntersuchung.

Schlussfolgerung

Die vorliegende Studie zeigt, dass der Einsatz von Vitamin E „blended“ Polyethylen-Inlays in der Hüftendoprothetik zuverlässig und sicher ist. Die klinischen Kurzzeitergebnisse sind denen von konventionellen Polyethylen-Inlays gleichwertig.

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Abbreviations

ADL:

Activities of daily living

ASA:

American Society of Anesthesiologists

CoC:

Ceramic-on-ceramic

HHS:

Harris hip score

HOOS:

Hip disability and osteoarthritis outcome score

HXLPE:

Highly cross-linked polyethylene

MoM:

Metal-on-metal

PROM:

Patient-reported outcome measures

QOL:

Quality of life

SD:

Standard deviation

THA:

Total hip arthroplasty

UCLA:

University of California Los Angeles

UHMWPE:

Ultrahigh molecular weight polyethylene

UHMWPE‑X:

Conventional cross-linked ultrahigh molecular weight polyethylene

UHMWPE-XE:

Highly cross-linked ultrahigh molecular weight polyethylene

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Funding

The study is financially supported by B. Braun-Aesculap AG, Tuttlingen, Germany; trial registration: NCT01713062.

Members of the Vitas group

Jäger M (Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marienhospital Mülheim, Contilia Gruppe für die Universität Duisburg-Essen, Germany), Landgraeber S, Serong S (Department of Orthopaedics, University of Saarland, Saarbrücken, Germany), Haversath M, von Wasen A (Department of Orthopaedics and Trauma Surgery, University of Duisburg-Essen, Essen, Germany), Windhagen H, Flörkemeier T, Budde S, Kubilay J, Noll Y (Klinik für Orthopädie, Diakovere Annastift, Medizinische Hochschule Hannover, Hannover, Germany), Delank KS, Baghdadi J (Klinik für Orthopädie und Unfallchirurgie, Universität Halle, Halle, Germany), Willburger R (Orthopädie und Unfallchirurgie, Katholisches Klinikum Bochum, Ruhr-Universität Bochum, Bochum, Germany), Dücker M (Klinik für Orthopädie, Marienhaus Klinikum St. Josef, Bendorf, Germany), Wilke A, Hütter F (Orthopädie, Unfall‑, Hand- und Wiederherstellungschirurgie, Elisabeth-Klinik, Bigge-Olsberg, Germany)

Author information

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

Correspondence to Dr. André Busch.

Ethics declarations

Conflict of interest

A. Busch, M. Haversath, VITAS group, A. Wegner and M. Jäger declare that they have no competing interests.

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1975 Helsinki declaration and its later amendments or comparable ethical standards. All patients consented to publish personal data in an anonymized form. The study was approved by the local ethics committee (11-4845-BO). The study was registered on Clinicaltrials.gov. (registration number NCT01713062).

Additional information

All authors were fully involved in the study and preparation of the manuscript.

The members of the Vitas group are listed at the end of the article.

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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Busch, A., Jäger, M., Jäger, M. et al. Vitamin E-blended versus conventional polyethylene liners in prostheses. Orthopäde (2019). https://doi.org/10.1007/s00132-019-03830-6

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Keywords

  • Biomaterials
  • Antioxidant
  • Patient-related outcome measurement
  • Total hip replacement
  • Prosthesis durability

Schlüsselwörter

  • Biomaterialien
  • Antioxidans
  • Patientenbezogene Ergebnismessung
  • Hüfttotalendoprothese
  • Prothesenhaltbarkeit