ARTHROPLASTY
Metal release and metal allergy after total hip replacement with resurfacing versus conventional hybrid prosthesis 5-year follow-up of 52 patients
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(20):2 Acta Orthop. 2014 Aug;85(4):348-54. doi: 10.3109/17453674.2014.922730. Epub 2014 Jun 16.54 patients with primary osteoarthritis were randomized to undergo either reintroduced metal-on-metal (MOM) total hip resurfacing arthroplasty or metal-on-polyethylene (MOP) total hip arthroplasty, with the purpose of determining if the added excretion of metal ions from MOM results in heightened prevalence of metal allergies. A significant increase in cobalt and chromium in the MOM group was observed throughout the 5 year study period, but did not translate to increased metal allergy.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
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。
3/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
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？
Metal-on-metal (MOM) total hip arthroplasties were the standard of care in the 1960's and 1970's, but researchers soon discovered MOM implants released high levels of cobalt, chromium, and nickel. Focus shifted towards metal-on-polyethylene (MOP) arthroplasties instead, which were later found to have a high incidence of osteolysis and aseptic loosening in young, active patients, which many consider an even greater problem. Consequently, MOM arthroplasties were reintroduced, but the risk of metal hypersensitivity has become an issue due to greater absolute number of wear particles. Based on the hypothesis that metal allergies can be caused by prolonged metal exposure, the aim of this study was to determine if MOM arthroplasties increased the incidence of metal allergies in exposed patients.
主な研究課題は何ですか？
Is there greater incidence of metal allergy in patients undergoing metal-on-metal total hip resurfacing arthroplasty compared to patients undergoing metal-on-polyethylene total hip arthroplasty 5 years post-surgery?
重要な知見は？
- A significant 10- to 20- fold increase in cobalt and chromium was observed in the urine of the MOM group throughout the 5 year follow-up (p<0.05), while no differences were observed in patients receiving implants with MOP or COP.
- The patch test revealed no significant difference in the incidence of metal hypersensitivity at 5 years between the MOM and MOP/COP groups, nor between MOP and COP patients (both p>0.05).
- The lymphocyte transformation assay revealed no significant difference in cellular reactivity at 5 years between the MOM and MOP/COP groups, nor between MOP and COP patients (both p>0.05).
最も覚えておくべきことは？
The significant increase of cobalt and chromium levels throughout the 5 year study period did not translate to increased metal allergy in patients that underwent metal-on-metal (MOM) total hip arthroplasty.
それが私の患者ケアにどのように影響するか？
It appears MOM total hip arthoplasty does not increase the incidence of metal allergies, but the long-term effects of metal exposure still remain uncertain. Results must be interpreted with caution, as the metel-on-metal group lost 7 patients to final follow-up.
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