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

被引:34
作者
Pijls, B. G. [1 ]
Meessen, J. M. T. A. [1 ]
Schoones, J. W. [4 ]
Fiocco, M. [2 ,3 ]
van der Heide, H. J. L. [1 ]
Sedrakyan, A. [5 ,6 ]
Nelissen, R. G. H. H. [1 ]
机构
[1] Leiden Univ, Med Ctr, Dept Orthopaed, Leiden, Netherlands
[2] Leiden Univ, Med Ctr, Dept Med Stat, Leiden, Netherlands
[3] Leiden Univ, Inst Math, NL-2300 RA Leiden, Netherlands
[4] Leiden Univ, Med Ctr, Walaeus Lib, Leiden, Netherlands
[5] US FDA, FDA Med Device Epidemiol MDEpiNet Sci & Infrastru, Silver Spring, MD USA
[6] Weill Cornell Med Coll, Dept Healthcare Policy & Res, New York, NY USA
关键词
RANDOMIZED CONTROLLED-TRIAL; BONE-MINERAL DENSITY; SERUM-COBALT LEVELS; BEARING SURFACES; ION LEVELS; CANCER-RISK; POLYETHYLENE; REPLACEMENT; HEAD; TOXICITY;
D O I
10.1371/journal.pone.0156051
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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, Academic-SearchPremier, 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.
引用
收藏
页数:17
相关论文
共 62 条
[31]   Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial [J].
Jensen, C. ;
Aagaard, P. ;
Overgaard, S. .
OSTEOARTHRITIS AND CARTILAGE, 2011, 19 (09) :1108-1116
[32]   MORTALITY AFTER HIP REPLACEMENT Response to two recent BMJ papers on mortality after hip replacement: comparative modelling study [J].
Kandala, Ngianga-Bakwin ;
Connock, Martin ;
Pulikottil-Jacob, Ruth ;
Mistry, Hema ;
Sutcliffe, Paul ;
Costa, Matthew ;
Clarke, Aileen .
BMJ-BRITISH MEDICAL JOURNAL, 2014, 348
[33]   Mortality rates at 10 years after metal-on-metal hip resurfacing compared with total hip replacement in England: retrospective cohort analysis of hospital episode statistics [J].
Kendal, Adrian R. ;
Prieto-Alhambra, Daniel ;
Arden, Nigel K. ;
Carr, Andrew ;
Judge, Andrew .
BMJ-BRITISH MEDICAL JOURNAL, 2013, 347
[34]   Changes in metal levels and chromosome aberrations in the peripheral blood of patients after metal-on-metal hip arthroplasty [J].
Ladon, D ;
Doherty, A ;
Newson, R ;
Turner, J ;
Bhamra, M ;
Case, CP .
JOURNAL OF ARTHROPLASTY, 2004, 19 (08) :78-83
[35]   Patterns of Risk of Cancer in Patients with Metal-on-Metal Hip Replacements versus Other Bearing Surface Types: A Record Linkage Study between a Prospective Joint Registry and General Practice Electronic Health Records in England [J].
Lalmohamed, Arief ;
MacGregor, Alexander J. ;
de Vries, Frank ;
Leufkens, Hubertus G. M. ;
van Staa, Tjeerd P. .
PLOS ONE, 2013, 8 (07)
[36]   Short-term results of the M2a-taper metal-on-metal articulation [J].
Lombardi, AV ;
Mallory, TH ;
Alexiades, MM ;
Cuckler, JM ;
Faris, PM ;
Jaffe, KA ;
Keating, EM ;
Nelson, CL ;
Ranawat, CS ;
Williams, J ;
Wixson, R ;
Hartman, JF ;
Capps, SG ;
Kefauver, CA .
JOURNAL OF ARTHROPLASTY, 2001, 16 (08) :122-128
[37]   A comparative assessment of small-head metal-on-metal and ceramic-on-polyethylene total hip replacement [J].
Luebbeke, A. ;
Gonzalez, A. ;
Garavaglia, G. ;
Roussos, C. ;
Bonvin, A. ;
Stern, R. ;
Peter, R. ;
Hoffmeyer, P. .
BONE & JOINT JOURNAL, 2014, 96B (07) :868-875
[38]   Metal-on-metal versus polyethylene in hip arthroplasty: A randomized clinical trial [J].
MacDonald, SJ ;
McCalden, RW ;
Chess, DG ;
Bourne, RB ;
Rorabeck, CH ;
Cleland, A ;
Leung, F .
CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 2003, (406) :282-296
[39]   Cancer incidence and cause-specific mortality in patients with metal-on-metal hip replacements in Finland [J].
Makela, Keijo T. ;
Visuri, Tuomo ;
Pulkkinen, Pekka ;
Eskelinen, Antti ;
Remes, Ville ;
Virolainen, Petri ;
Junnila, Mika ;
Pukkala, Eero .
ACTA ORTHOPAEDICA, 2014, 85 (01) :32-38
[40]   What advantage is there to be gained using large modular metal-on-metal bearings in routine primary hip replacement? A PRELIMINARY REPORT OF A PROSPECTIVE RANDOMISED CONTROLLED TRIAL [J].
Malviya, A. ;
Ramaskandhan, J. R. ;
Bowman, R. ;
Kometa, S. ;
Hashmi, M. ;
Lingard, E. ;
Holland, J. P. .
JOURNAL OF BONE AND JOINT SURGERY-BRITISH VOLUME, 2011, 93B (12) :1602-1609