ARTHROPLASTY
A randomized RSA study concentrating especially on continuous migration
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(20):1 Acta Orthop. 2016 Jun;87(3):262-760 patients with knee osteoarthritis and scheduled for total knee arthroplasty were randomized to receive either a newer-generation Triathlon total knee system, or older-generation Duracon total knee system. The purpose of this study was to compare tibial component stability between groups at short- and mid-term follow-up. Three-dimensional translation and rotation of the component were assessed using radiostereometric analysis. After 5 years, significant difference between groups was only observed in varus-valgus rotation.
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。
2/4
Randomization
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
0/4
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 evolution of prostheses for total knee arthroplasty is continuously ongoing. Newer-generation implants are typically released and phased into clinical practice, ultimately replacing routine use of earlier-generation implants over many years. Within this process, careful consideration of long-term outcome of new implants is crucial to ensure patients are not experiencing worse stability and survivorship compared to older implants with proven track records.
主な研究課題は何ですか？
In total knee arthroplasty, was there any significant difference in radiostereometrically-assessed micromotion of the tibial component between the Triathlon and Duracon cemented knee systems over 5-year follow-up?
重要な知見は？
- No significant differences between the Duracon and Triathlon groups were observed after 5 years in medial-lateral translation (-0.34+/-1.26 vs. -0.33+/-0.46mm; p=1.0), caudal-cranial translation (-0.5+/-0.51 vs. 0.1+/-0.27mm; p=0.2), or posterior-anterior translation (-0.33+/-1.22 vs. 0.18+/-0.59; p=0.1).
- Overall, mean MTPM after 5 years did not significantly differ between the Duracon group (1.10+/-1.21) and the Triathlon group (0.66+/-0.38)
- No significant differences between the Duracon and Triathlon groups were observed after 5 years in anterior-posterior tilt (0.10+/-0.38 vs. -0.9+/-0.31deg; p=0.1) or internal-external rotation (-0.19+/-0.64 vs. -0.09+/-0.31deg; p=0.5). A significant difference was observed between groups in varus-valgus rotation of the component after 5 years, with 0.18deg (+/-0.48) varus rotation in the Duracon group versus 0.09deg (+/-0.28) valgus rotation in the Triathlon group.
- Continuous migration of the tibial component between years 1 and 2 was observed in 7/24 patients of the Duracon group and 5/26 patients of the Triathlon group.
- Continuous migration of the tibial component between years 2 and 5 was observed in 6/21 patients of the Duracon group and 3/21 patients of the Triathlon group (p=0.2).
最も覚えておくべきことは？
In total knee arthroplasty, 5-year maximum total point motion of the tibial component did not significantly differ between patients treated with a Triathlon or Duracon prosthesis. A similar number of patients between groups throughout follow-up demonstrated MTPM values exceeding the thresholds set by the current study as indicative of continuous migration.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that the newer-generation Triathlon total knee system has a similar mid-term migration profile to that of the predecessor-generation Duracon total knee system. Continued follow-up is necessary to determine if the migration profiles of these two systems remain similar into the long-term.
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
