The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up

Yama Afghanyar, Sebastian Joser, Jonas Tecle, Philipp Drees, Jens Dargel, Philipp Rehbein, Karl Philipp Kutzner, Yama Afghanyar, Sebastian Joser, Jonas Tecle, Philipp Drees, Jens Dargel, Philipp Rehbein, Karl Philipp Kutzner

Abstract

Background: The newest generation of cementless titanium-coated, isoelastic monoblock cup with vitamin E-blended highly cross-linked polyethylene (HXLPE) was introduced to the market in 2009. The aim of the present study was to obtain mid-term follow-up data including migration and wear analyses.

Methods: This prospective study investigated 101 primary total hip arthroplasty (THA) cases in 96 patients treated at a single institution. Patients were allowed full weight-bearing on the first day postoperatively. Harris hip score (HHS) and pain and satisfication on a visual analogue scale (VAS) were assessed at a mean follow-up of 79.0 months. Migration and wear were assessed using Einzel-Bild-Roentgen-Analyse (EBRA) software. Radiological acetabular bone alterations and complications were documented.

Results: At mid-term follow-up (mean 79.0 months, range: 51.8-101.7), 81 cases with complete clinical and radiological data were analyzed. Utilisable EBRA measurements were obtained for 42 hips. The mean HHS was 91.1 (range 38.0-100.0), VAS satisfaction was 9.6 (range 6.0-10.0), VAS rest pain was 0.2 (range 0.0-4.0), and VAS load pain was 0.6 (range 0.0-9.0). Mean migration was 0.86 mm (range: 0.0-2.56) at 24 months and 1.34 mm (range: 0.09-3.14) at 5 years, and the mean annual migration rate was 0.22 (range: - 0.24-1.34). The mean total wear was 0.4 mm (range: 0.03-1.0), corresponding to a mean annual wear rate of 0.06 mm per year (range: 0.0-0.17). Radiographic analysis did not reveal any cases of osteolysis, and no revision surgeries had to be performed.

Conclusions: After using vitamin-E blended HXLPE in cementless isoelastic monoblock cups, there were no obvious signs of osteolysis or aseptic loosening occurred. No patients required revision surgery after mid-term follow-up. Cup migration and wear values were well below the benchmarks considered predictive for potential future failure.

Trial registration: The trial registration number on ClinicalTrials.gov : NCT04322916 (retrospectively registered at 26.03.2020).

Keywords: Cementless acetabular cup; EBRA; Migration; Total hip arthroplasty; Vitamys; Wear.

Conflict of interest statement

KPK and PR serve as instructors for Mathys Ltd., Bettlach, Switzerland. PR also serves as medical advisor. All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
a RM Classic cup; b RM Pressfit cup; c RM Pressfit vitamys cup. (Mathys Ltd., Bettlach, Switzerland)
Fig. 2
Fig. 2
Radiographs of an RM Pressfit vitamys cup (Mathys Ltd. Bettlach, Switzerland) immediately after surgery (a) and at 5-year follow-up (b). The patient showed signs of a sclerotic line in Zones 1 and 2
Fig. 3
Fig. 3
Study flow diagram

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