High Revision Rate for Large-head Metal-on-metal THA at a Mean of 7.1 Years: A Registry Study
Authors: Seppänen Matti , Laaksonen Inari , Pulkkinen Pekka , Eskelinen Antti , Puhto Ari-Pekka , Kettunen Jukka , Leskinen Jarkko , Manninen Mikko , Mäkelä Keijo 
Published: June 2018

Abstract

Background
Large-diameter head metal-on-metal (MoM) THA has largely been abandoned as a result of higher than anticipated revision rates. However, the majority of these implants are still in situ. Although earlier reports from the Finnish Arthroplasty Register noted similar short-term survivorship between large-diameter head MoM THA and conventional cemented THA, longer term survivorship of this population is unclear. Although reported revision rates for this implant group have been high, the majority of these implants have not been revised and followup is important to improve long-term management.

Questions/purposes
The purposes of this study were (1) to compare the 10-year competing risk survivorship of large-diameter head MoM THA with the survivorship of conventional THA in the Finnish Arthroplasty Register; (2) to report the large-diameter head MoM THA survival at the manufacturer/brand level; and (3) to identify the most common reasons for revision of large-diameter head MoM THA in the Finnish Arthroplasty Register.

Methods
The six most commonly used large-diameter head (≥ 38 mm) MoM THA devices in Finland between years 2004 and 2013 were selected (n = 10,959 implants). The completeness of the Finnish Registry is > 95% in primary THA and patients are censored from the date of death or at the point of emigration; followup continued until the end of 2015. The conventional THA control group consisted of the two most frequently used devices (Vision/Bimetric and ABG II/ABG II) with metal-on-polyethylene or ceramic-on-ceramic bearing surfaces implanted between 2002 and 2013 (n = 5177). The study group was formed by selecting all pairs of large-diameter head MoM and reference THA protheses within the same age group ( < 49, 50-54, 55-59, 60-64, 65-69, 70-74, and 75+ years), sex, diagnosis (osteoarthritis, other), and hospital yearly operation count (< 100 operations yearly, ≥ 100 operations yearly); 5166 matched pairs were identified. Revision for any reason was considered as the failure endpoint of followup. Implant survival (the proportion not revised) was calculated from corresponding cumulative incidence function adjusted for patient death as a competing event for revision. Large-diameter head MoM implant group revision hazard ratios with 95% confidence intervals were estimated with age group, sex, diagnosis, and hospital yearly operation count as confounding factors in a Cox regression model.

Results
Ten-year survivorship free from all-cause revision was lower for THAs that used a large-diameter femoral head than it was for the control group of conventional THA (83% [95% confidence interval {CI}, 82%-84%] versus 92% [95% CI, 91%-93%]). At the implant level, every large-diameter head MoM THA had a higher risk for revision compared with the conventional THA control group from the fourth postoperative year onward. The highest survival of MoM THA was 88% (95% CI, 86%-90%) for the ReCap/Bimetric and the lowest survival was 46% (95% CI, 41%-51%) for the recalled ASR with either the Summit® or Corail® stem. The most common revision reason in the MoM THA group was adverse reaction to metal debris, whereas dislocation was predominant in the conventional THA control group.

Conclusions
The revision rate for all large-diameter head MoM THAs in this timeframe in the Finnish Arthroplasty Register is unacceptably high and in our view supports the decision to abandon their use. In agreement with the directives of other national organizations, we recommend regular followup of all patients with large-diameter head MoM THA. Based on our results, strict guidelines for followup should be maintained over the lifetime of the implant to assess patient symptoms and recommend revision when indicated.

Level of Evidence
Level III, therapeutic study.