FOOT & ANKLE
Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation
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これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):73 J Bone Joint Surg Am. 2010 Dec 1;92(17):2767-75. Epub 2010 Oct 29.144 patients with primary complete Achilles tendon rupture were randomized to be treated with either a surgical repair and accelerated functional rehabilitation or with only the accelerated functional rehabilitation. Over the course of a two year follow up, it was observed that Achilles tendon rupture led to clinically similar results between the two treatment 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。
3/4
Randomização
3/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
5/5
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？
Achilles tendon rupture is a common sporting injury in adults with an increasing incidence due to continued sporting activity with growing age. So far evidence had favored surgical repair to be better in preventing re-rupture rates. However, the treatment of choice still remains controversial. Early weight-bearing with protected range of motion demonstrates better range of motion, strength, and return to activity, while minimizing re-ruptures or possibility of healing in a lengthened position. This study aimed to compare outcome of patients with acute Achilles tendon ruptures, who had been treated with operative repair and accelerated functional rehabilitation, with outcomes of similar patients who had been treated with accelerated functional rehabilitation alone.
主な研究課題は何ですか？
Are there any long-term differences in the results between patients receiving operative repair and accelerated functional rehabilitation versus those patients receiving accelerated functional rehabilitation alone, in the two-year post-operative period?
重要な知見は？
- At the 2-year follow-up, re-rupture occurred in two patients in the operative group at one and three months after injury and in three patients in the nonoperative group at one, two, and three months after injury.
- There was significant difference in the plantar flexion strength ratio (affected to unaffected limb) at 240 degrees at two years (mean difference, 14.15%; 95% CI, 1.12% to 27.19%; p = 0.03) in favor of the operative group.
- The mean range of dorsiflexion was 20.3 degrees +/- 12 degrees in the operative group and 17.9 degrees +/- 6.0 degrees in the nonoperative group. The mean range of plantar flexion was 44.5 degrees +/- 8.4 degrees in the operative group and 46.8 degrees +/- 8.5 degrees in the nonoperative group.
- The side-to-side difference in plantar flexion range of motion was greater in the nonoperative group than in the operative group (mean difference between groups, 2.21 degrees; 95% CI, 3.9 degrees to 0.5 degrees; p = 0.01)
- The mean side-to-side difference in calf circumference was 1.7 +/- 2.0 cm in the operative group and 1.5 +/- 5.6 cm in the nonoperative group. This difference was not significant (mean difference between groups, 0.2 cm; 95% CI, 1.8 to 1.3 cm; p = 0.75).
- The mean Leppilahti score was 82.6 +/- 11.1 points in the operative group and 82.2 +/- 12.3 points in the nonoperative group. These values were not significant (mean difference: 0.4 point; 95% CI, 5.4 to 5.0 points; p = 0.89).
- Study pitfalls, however, included no specification of intent to treat analysis, a largely male population, and an under-powered sample size.
最も覚えておくべきことは？
The results of this study supported the use of accelerated functional rehabilitation and nonoperative treatment for acute Achilles tendon ruptures. All measured outcomes were clinically similar to those experienced for operative treatment. However, this study was under-powered.
それが私の患者ケアにどのように影響するか？
In patients with Achilles tendon rupture, accelerated functional rehabilitation appears to be effective when used after surgical and nonsurgical treatments. Further methodologically sound studies with sufficient power are necessary to confirm these findings.
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