ARTHROPLASTY
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.
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2017;5(2):6 PLoS One. 2016 Jun 13;11(6):e0156051. doi: 10.1371/journal.pone.0156051. eCollection 201638 randomized controlled trials and 9 observational studies were included in this systematic review and meta-analysis to compare mortality and morbidity rates between metal-on-metal total hip arthroplasty (MOM THA) and non-metal-on-metal THA (non-MOM THA). Results of the meta-analysis indicate no significant differences in mortality rate within 5 years, or from 5-10 years. However, mortality rate was significantly higher among MOM THA groups compared to non-MOM THA groups in studies with >10-year follow-up. Additionally, a trend towards a greater rate of surgical revision was observed in the MOM THA group.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Introduction
4/4
Accessing Data
4/4
Analysing Data
4/4
Results
3/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Recent observational studies providing long-term follow-up have demonstrated an increased risk of mortality with the first generation of metal-on-metal total hip arthroplasty implants. However, conflicting data has been presented for second-generation metal-on-metal implants. Metal-on-metal total hip arthroplasty implants are still in use today in some settings and a comprehensive meta-analysis is needed to determine the mortality and morbidity of the different generations of MOM THA implants over the long-term.
主な研究課題は何ですか？
What are the overall mortality and morbidity rates of first- and second-generation metal-on-metal bearings when compared to non-metal-on-metal bearings in primary total hip arthroplasties evaluated in randomized controlled trials and observational studies?
重要な知見は？
- Mortality risk difference was assessed between MOM THA and non-MOM THA at three different follow-up periods; <5 years, 5-10 years, and >10 years. No significant difference was observed within 5 year follow-up (13 RCTs; RD 0.1% [95%CI -1.3% to 1.0%]) or from 5-10 year follow-up (9; RD 0.7% [95%CI -3.0% to 1.7%]). In studies with >10-year follow-up, a significantly higher rate of mortality was observed among MOM THA groups compared to non-MOM THA groups (3 RCTs/1 Observational; RD 4.4% [95%CI1.4% to 7.4%]).
- Observational studies of first-generation MOM THA demonstrated a trend toward increased mortality compared to non-MOM THA (RR 1.05) This finding was in line with the results from RCTs. Observational studies evaluating second generation MOM demonstrated a decreased risk of mortality for MOM THA compared to non-MOM THA, which was in contrast to long-term results from RCTs.
- Morbidity in the form of surgical complications was reported in 26 RCTs, all evaluating second generation MOM THA in comparison to non-MOM THA. The risk of revision was greater in the MOM group RD: 0.8% [95%CI -0.1% to 1.7%] I-squared 0%, but this difference was not significant.
- The risk of cancer was reported in 4 observational studies: 1 evaluating first generation MOM THA and 3 evaluating second generation MOM THA. The first generation MOM THA demonstrated a greater risk of cancer compared to non-MOM THA, but this increased risk was not significant, while the second generation demonstrated no difference compared to non-MOM THA.
最も覚えておくべきことは？
The long-term mortality rates appear to be increased in metal-on-metal total hip arthroplasty compared to non-metal-on-metal hip arthroplasty, while mortality rate within 10 years does not appear to differ significantly. Additionally, the rate of surgical revision appears to be higher with the use of metal-on-metal total hip arthroplasty compared to non-metal-on-metal total hip arthroplasty.
それが私の患者ケアにどのように影響するか？
The results of this meta-analysis demonstrated a higher rate of mortality with the use of metal-on-metal implants in total hip arthroplasty in randomized controlled trials with long-term follow-up. In addition to the higher rate of mortality, there was a trend towards increased morbidity requiring surgical revision. The result from this study highlights the need for patients who have received a metal-on-metal implant in the past to be closely followed. Additionally, the result of this trial indicates that there is no case for the use of metal-on-metal THA implants due to the increased risk of mortality.
免責事項
このページに記載されている内容は、情報提供のみを目的としたものであり、専門的な医療アドバイス、診断、治療の代わりとなるものではありません。治療が必要な場合は、必ず医師の診断を仰ぐか、最寄りの救急外来を受診してください。このページに記載されている内容に関して個人が表明した意見、信念、見解は、OrthoEvidenceの意見、信念、見解を反映するものではありません。
0の4 月間無料記事のロック解除
