HAND & WRIST
External or internal fixation in the treatment of non-reducible distal radial fractures?
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):151 Acta Orthop. 2011 Oct;82(5):610-3. Epub 2011 Sep 650 patients with unstable, irreducible, or comminuted distal radial fractures were randomized to either receive open reduction with internal fixation (ORIF) or closed reduction with bridging external fixation. The purpose of this trial was to compare grip strength and range of motion over a medium-term follow-up. The 1 year results indicated that there was a significant difference in grip strength and ROM between groups favoring ORIF. However, this difference was not maintained at 5 years with both groups approaching the normal grip strength and ROM values of the uninjured side.
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
Randomização
2/4
Medidas de resultado
1/4
Inclusão/Exclusão
2/4
Descrição do tratamento
2/4
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？
Surgical treatment is typically recommended for patients with unstable, non-reducible distal radial fractures. The standard method of fixation is external fixation however, ORIF has increased in popularity due to introduction of the volar locking plate technique. A previous randomized study demonstrated superior grip strength and forearm rotation at year with ORIF compared to closed reduction and external fixation. This present study provided an evaluation of the same patients at a 3-7 year follow-up (mean 5). This study was needed to determine if the short term results found in the 1 year study persist over time.
主な研究課題は何ですか？
Does ORIF result in improved grip strength and forearm rotation compared to external fixation in the treatment of unstable distal radial fractures, measured at a mean follow up of 5 years?
重要な知見は？
- All 50 patients that were randomized completed the QuickDASH questionnaire, and 45 patients participated in the clinical and radiographic assessment.
- The mean grip strength (reported as a percentage of the uninjured side) was 95% (SD 12) in patients that underwent internal fixation, compared to 90% (SD 21) in the external fixation group (p=0.3, 95% CI:-4 to 16 percent units).
- QuickDASH scores, range of motion, general health and radiographic outcomes were similar between both groups.
最も覚えておくべきことは？
At the 1 year follow up of the study, there were statistically significant differences between groups regarding grip strength and pronation-supination that favoured ORIF. However, this previously reported difference was lost at the 5 year follow-up, as both groups approached the normal grip strength and ROM values of the uninjured side.
それが私の患者ケアにどのように影響するか？
ORIF and external fixation appear to provide similar long-term strength and ROM outcomes for non-reducible distal radial fractures when compared to the uninjured arm. However, the short term outcomes should be considered when determining the best treatment option as ORIF may provided better strength and ROM outcomes over the first post-operative year.
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