TRAUMA
Bridging external fixation and supplementary Kirschner-wire fixation versus volar locked plating for unstable fractures of the distal radius: A RANDOMISED, PROSPECTIVE TRIAL
This report has been verified
by one or more authors of the
original publication.
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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(3):107 J Bone Joint Surg Br. 2008 Sep;90(9):1214-2188 patients with distal radius fracture were selected for surgical fixation. This group was randomized to be managed with either bridging external fixation with supplementary Kirschner-wire (K-Wire) fixation or volar locked plating with screws. The patients treated by volar plating had a significant early improvement in the range of movement of the wrist; this advantage diminished with time, and in absolute terms the difference in range of movement was clinically non-relevant. No clinically significant differences in the reductions was observed on radiographs. Both groups had comparable function at one year. No definitive advantage of either treatment could be established; however, fewer re-operations were required in the external fixation group.
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
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
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？
Distal radius fractures are a common injury, especially in the bones weakened by osteoporosis in post-menopausal women. As with any other fractures the anatomic reduction and immobilization is the key management principle. A wide variety of options are available ranging from conservative management in a cast to closed reduction and pinning, bridging and non-bridging external fixation, and open reduction with plate and screw fixation through a variety of approaches. Each technique has its own sets of merits and demerits.This study aimed to compare the clinical outcomes of bridging external fixation and supplementary Kirschner-wire fixation to volar locked plating.
主な研究課題は何ですか？
Does the bridging external fixation and supplementary Kirschner-wire fixation has better clinical outcomes at 1 year than volar locked plating for unstable fractures of the distal radius?
重要な知見は？
- No differences in the mean DASH scores at any of the follow-up assessments were observed between the groups and compared to the patients self-reported baseline levels. A trend towards significantly improved DASH scores was, however, found at 6 months, in favour of the external fixation group (p=0.06)
- Patients treated by volar plating had a statistically significant improvement in the range of movement of the wrist at 3 months: pronation (p<0.001), supination (p=0.05), extension (p=0.05) and radial deviation (p=0.002). This improvement diminished at 6 months and 1 year.
- Radiologically, there were no clinically significant differences in the reductions, although more patients with AO/OTA (Orthopaedic Trauma Association) type C fractures were allocated to the external fixation group.
- Radiologically, all the fractures united except one. Complication rate was comparable with 7 patients (18.4%) in the external fixation group having 7 complications compared with 8 (20.5%) in the plate group.
最も覚えておくべきことは？
The patients treated by volar plating had a statistically significant early improvement in the range of movement of the wrist, which diminished with time and was clinically non-relevant. No clinically significant differences in the reductions was observed on radiographs. Both groups had comparable function at one year. No definitive advantage of either treatment could be established; however, fewer re-operations were required in the external fixation group.
それが私の患者ケアにどのように影響するか？
Each method has its own sets of merits and demerits, which must be considered for each patient's profile, and appropriate method should be chosen based on thorough assessment. Further research with larger populations is needed.
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