ARTHROPLASTY
Excessive distal migration of fiber-mesh coated femoral stems
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):23 Acta Orthop. 2011 Jun;82(3):308-14. Epub 2011 Apr 1950 arthritic patients undergoing total hip arthroplasty were randomized to receive either distally tapered, extended coated stems, or straight proximally coated stems, to study potential differences in implant migration. At 2 years post-surgery, radiostereometric analysis revealed that both stem types demonstrated large amounts of implant migration, with no significant differences between groups.
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。
4/4
Randomization
3/4
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？
The varying types of femoral stem coatings used for total hip arthroplasty have been investigated in studies to determine implant migration and rotation. This study aims to further investigate the outcomes with respect to extended coating versus proximal coating.
主な研究課題は何ですか？
Does an extended coated stem lead to reduced implant migration two years postoperatively, when compared to a proximally coated stem in patients undergoing total hip arthroplasty for primary osteoarthritis?
重要な知見は？
- no statistically significant difference during RSA assessment with respect to rotation or translation detected between groups at any of the follow-up points
- implant migration of both groups was significant from initial postoperative measurements
最も覚えておくべきことは？
Both implant stem groups demonstrated significant migration in comparison to baseline measures; however, no statistically significant difference was detected between the groups. The authors recommend that additional follow-ups are required in future trials.
それが私の患者ケアにどのように影響するか？
Both implants demonstrate significant migration,which warrants further investigation; however, this trial was unable to conclude which coating is superior. Additionally, the authors cite this study as an evidence for the necessity of RSA, as standard protocol to monitor all new implants.
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