ARTHROPLASTY
Preoperative methylprednisolone does not reduce loss of knee-extension strength after total knee arthroplasty: A randomized, double-blind, placebo-controlled trial of 61 patients
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2018;6(2):4 Acta Orthop. 2017 Oct;88(5):543-54970 patients undergoing unilateral fast-track total knee arthroplasty were included in this trial to determine if a single preoperative dose of methylprednisolone can reduce the loss of knee-extension strength at discharge. Patients were randomized to receive a preoperative injection of methylprednisolone or placebo. Outcomes included knee extension strength (Nm/kg), knee circumference, the timed up-and-go (TUG) test, knee pain, on a visual analog scale, during knee extension strength test and TUG test, and C-reactive protein levels. There were no differences between groups in the loss of knee extension strength, knee circumference, timed up-and-go tests and knee pain. C-reactive protein levels were significantly reduced in the methylprednisolone group at 24 and 48 hours.
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
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/5
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 patients face strength deficit in the knee following total knee arthroplasty. The inflammatory response following surgery has been theorized to be a potential major contributor to extension strength deficit. Therefore, modifying the inflammatory response with a corticosteroid, such as methylprednisolone, may help mitigate strength loss after total knee arthroplasty.
主な研究課題は何ですか？
In total knee arthroplasty, does preoperative intravenous methylprednisolone lead to a significantly smaller drop in knee extension strength when compared to placebo saline, assessed at discharge?
重要な知見は？
- Reduction in knee extension strength from baseline to discharge did not significantly differ between the methylprednisolone group (-1.04Nm/kg [range; 0.22-1.9]) and the placebo group (-1.02Nm/kg [range; 0.22-1.6]) (p=0.8).
- The increase in VAS pain from baseline to discharge, during both strength testing and TUG test did not significantly differ between the methylprednisolone group and the placebo group (p=0.7 and 0.1, respectively).
- The increase in knee circumference from baseline to discharge did not significantly differ between the methylprednisolone group (+3.6cm [range; -1.5, 6.5]) and the placebo group (+3.8cm [range; 0.8-7.2]) (p=0.7).
- C-reactive protein levels were significantly reduced at 24 and 48 hours in the methylprednisolone group compared to the placebo group (P<0.001)
- The increase in TUG test time from baseline to discharge did not significantly differ between the methylprednisolone group (+16s [range; 2.9-40]) and the placebo group (+17s [range; 0.6-53]) (p=0.8).
最も覚えておくべきことは？
In total knee arthroplasty, intravenous methylprednisolone 125mg did not have a significant effect on knee extension strength mitigation when compared to intravenous placebo saline.
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 intravenous methylprednisolone in total knee arthroplasty does not have a significant benefit on early clinical parameters after surgery, including knee extension strength, knee pain, swelling, and function. Additional research should be undertaken to identify optimal strategies in recovery knee strength and function following total knee arthroplasty.
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