ARTHROPLASTY
A randomized study on migration of the Spectron EF and the Charnley flanged 40 cemented femoral components using radiostereometric analysis at 2 years
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):31 Acta Orthop. 2011 Oct;82(5):538-44. Epub 2011 Sep 6150 patients with primary or secondary osteoarthritis of the hip were randomized to undergo THA with either a Charnley or Spectron EF femoral stem. The 2 year results indicate that the Spectron EF stem has superior stability when compared to the Charnley stem, which demonstrated significantly more stem retroversion and posterior translation. Future studies are required to determine if similar results are found over longer follow-up periods.
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
Randomização
2/4
Medidas de resultado
2/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
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？
There are many possible mechanisms that can cause femoral stem loosening in cemented total hip replacements including the material, design, and surface finish. Debonding between the cement and femoral stem initiates this loosening, and to address this issue there are many different femoral stem designs aimed at increasing fixation and preventing loosening. The Spectron femoral stem is increasingly being used and has resulted in successful outcomes; however, there is a lack of comparisons to other femoral stems.
主な研究課題は何ですか？
What effect does the use of a Charnley or Spectron EF femoral stem have on migration in patients with hip osteoarthritis undergoing cemented total hip replacement, measured over 2 year follow-up period?
重要な知見は？
- At 2 years, stem retroversion (mean internal rotation) was 2.3 and 0.7 degrees (p<0.001), and posterior translation (negative translation along z-axis) was 0.44mm and 0.17mm (p=0.002) for the patients in the Charnley group and Spectron EF groups respectively.
- At 2 years, subsidence (migration along y-axis) was 0.26mm for Charnley group, compared to 0.20mm for Spectron EF group (p=0.5).
最も覚えておくべきことは？
Results from the two year follow-up found that the Charnley stem had more significantly more stem retroversion and posterior translation, compared to the Spectron EF stem.
それが私の患者ケアにどのように影響するか？
Although the Spectron EF stem proved to be more stable throughout the 2 year duration of this study, these good short-term results do not necessarily translate into successful long-term outcomes. Therefore, studies with longer-term follow up periods, which evaluate the impact of design, materials and surface finish of the implant on loosening and resulting migration, are required.
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