ARTHROPLASTY
Migration and clinical outcome of mobile-bearing versus fixed-bearing single-radius total knee arthroplasty
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2018;6(11):6 Acta Orthop. 2018 Apr;89(2):190-19648 patients scheduled for total knee arthroplasty with a single radius implant were randomized to either a mobile-bearing or fixed-bearing design. Patients were primarily followed up for tibial component migration after 6 years. Secondary outcomes also included clinical scores and knee range of motion. Results demonstrated no significant differences between groups for any of the assessed outcome measures.
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。
1/4
Randomization
3/4
Outcome Measurements
0/4
Inclusion / Exclusion
2/4
Therapy Description
3/5
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？
Many studies and analyses have been conducted comparing outcomes between mobile-bearing and fixed-bearing total knee implants. However, a number of these studies were completed using older implant designs, and may not reflect the comparative efficacy of newer designs. Furthermore, specific efficacy when considering single radius implants has not been thoroughly investigated previously.
主な研究課題は何ですか？
In single-radius total knee arthroplasty, is there a significant difference in mid-term (6-year) migration between a mobile-bearing implant and a fixed-bearing implant?
重要な知見は？
- Maximum total point motion at 6 years did not significantly differ between the MB group (1.22mm [95%CI 0.75-1.80]) and the FB group (0.90mm [95%CI 0.49-1.41]) (p=0.30).
- Change in range of knee flexion after 6 years did not significantly differ between the MB group and the FB group (p=0.2).
- Change in range of knee extension after 6 years did not significantly differ between the MB group and the FB group (p=0.2).
- Change in Knee Society Knee Scores after 6 years did not significantly differ between the MB group and the FB group (p=0.7).
- Change in Knee Society Function Scores after 6 years did not significantly differ between the MB group and the FB group (p=0.2).
- Revision due to aseptic loosening was performed in no patients of the MB group and 1 patient of the FB group. Revision due to septic loosening was performed in 1 patient of the MB group and 1 patients of the FB group.
- Recruitment was stopped early due to the investigation of one case of mobile bearing insert dislocation.
最も覚えておくべきことは？
In single-radius total knee arthroplasty, no significant differences in 6-year tibial migration, clinical outcome or revision rate were observed between cases completed using a mobile-bearing design and cases completed using a fixed-bearing design.
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 mid-term migration and clinical outcome is similar between mobile-bearing and fixed-bearing single-radius total knee implants. Therefore, it is unknown if there is any clear advantage of one design over the other.
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