Increased Mortality in Metal-on-Metal versus Non-Metal-on-Metal Primary Total Hip Arthroplasty at 10 Years and Longer Follow-Up: A Systematic Review and Meta-Analysis

PLoS One. 2016 Jun 13;11(6):e0156051. doi: 10.1371/journal.pone.0156051. eCollection 2016.

Abstract

Importance: There are concerns about increased mortality in patients with metal-on-metal bearings in total hip arthroplasty (THA).

Objective: To determine the mortality and the morbidity in patients with metal-on-metal articulations (MOM THA) compared to patients with non-metal-on-metal articulations (non-MOM THA) after primary total hip arthroplasty.

Data sources: Search of PubMed, MEDLINE, EMBASE, Web of Science, Cochrane, CINAHL, AcademicSearchPremier, ScienceDirect, Wiley and clinical trial registers through March 2015, augmented by a hand search of references from the included articles. No language restrictions were applied.

Study selection: Two reviewers screened and identified randomised controlled trials and observational studies of primary total hip arthroplasty comparing MOM THA with non-MOM THA.

Data extraction and synthesis: Two reviewers independently extracted study data and assessed risk of bias. Risk differences (RD) were calculated with random effect models. Meta-regression was used to explore modifying factors.

Main outcomes and measures: Difference in mortality and difference in morbidity expressed as revisions and medical complications between patients with MOM THA and non-MOM THA.

Results: Forty-seven studies were included, comprising 4,000 THA in randomised trials and over 500,000 THA in observational studies. For mortality, random effects analysis revealed a higher pooled RD of 0.7%, 95%, confidence interval (CI) [0.0%, 2.3%], I-square 42%; the heterogeneity was explained by differences in follow-up. When restricted to studies with long term follow-up (i.e. 10 years or more), the RD for mortality was 8.5%, 95%, CI [5.8%, 11.2%]; number needed to treat was 12. Further subgroup analyses and meta-regression random effects models revealed no evidence for other moderator variables (study level covariates, e.g. resurfacing vs. non-resurfacing MOM) than follow-up duration. The quality of the evidence presented in this meta-analysis was characterized as moderate according to the CLEAR-NPT (for non-pharmacological trials) and Cochrane risk of bias Table.

Conclusions and relevance: Meta-analysis suggests there may be an increased long-term risk of mortality and revision surgery for patients with MOM THA compared to patients with non-MOM THA.

Registration: PROSPERO 2014:CRD42014007417.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Arthroplasty, Replacement, Hip / adverse effects
  • Arthroplasty, Replacement, Hip / methods*
  • Arthroplasty, Replacement, Hip / mortality*
  • Follow-Up Studies
  • Hip Prosthesis / adverse effects
  • Hip Prosthesis / statistics & numerical data*
  • Humans
  • Metal-on-Metal Joint Prostheses / adverse effects
  • Metal-on-Metal Joint Prostheses / statistics & numerical data*
  • Mortality / trends
  • Prosthesis Failure / trends
  • Reoperation / mortality
  • Reoperation / statistics & numerical data

Grants and funding

There was no external funding for this work. All authors are employees of the Leiden University Medical Center or FDA Medical Device Epidemiology (MDEpiNet) Science and Infrastructure Center. The sponsor did not take part in the design or conduct of the study; nor in the collection, management, analysis, or interpretation of the data; nor in the preparation, review, or the approval of the manuscript. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.