PEDIATRIC ORTHOPAEDICS
Hemiepiphysiodesis: Similar treatment time for tension-band plating and for stapling
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by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(8):18 Acta Orthop. 2013 Apr;84(2):202-6. doi: 10.3109/17453674.2013.782526. Epub 2013 Mar 14The present trial evaluated 20 children with idiopathic genu valgum (IGV) who were randomized for hemiepiphysiodesis with either a tension band construct or staples to correct angular deformities. To compare the efficiency of both treatment methods, the time for correction of deformity, changes in angles as measured on radiographs, pain by visual analog scale (VAS) and analgesic consumption were recorded. The post-operative results indicated no differences between using staples and tension band plating for all outcomes.
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
3/4
Outcome Measurements
3/4
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？
Hemiepiphysiodesis is used to correct excessive angular deformities in the extremities of children. Implants stop unilateral growth until the deformity is corrected and are then removed to resume growth. Staples have been used for this procedure, but are associated with complications such as staple migration, breakage, and premature growth plate closure. More recently, tension-band plating has been introduced for faster correction and prevention of growth plate compression. However, no known randomized trial has demonstrated superiority of tension-band plating technique over stapling.
主な研究課題は何ですか？
How do the clinical and radiographic effects of stapling compare to tension-band plating in children with IGV of the distal femur?
重要な知見は？
- The tension band group and staples group had similar time taken to correct idiopathic genu valgum deformity (mean 340 days (286–394) vs. mean 349 days (263–435), respectively) (p=0.8). Cohen’s delta showed an estimated effect size of 0.075.
- No implant failures, infection or growth arrests occurred, while all 20 children achieved correction of genu valgum deformity.
- Although groups differed in gender (M/F in staples group = 3/7 vs tension band = 8/2) and age (tension band group mean age = 10.1 ( 8–14 years) vs. staples group mean age = 11.1 (6–13) years), there were no differences in treatment time, preoperative intermalleolar distance, and measured radiographic values (LDFA, MPTA, and MAD) treatment (p>0.05).
- VAS pain was recorded for 18/20 children and was similar in both groups (p>0.05) 72 hours postoperatively.
- 1 child in tension-band group had a rebound of intermalliolar distance of 8 cm and was scheduled for surgery
最も覚えておくべきことは？
Hemiepiphysiodesis with both tension band and staples have similar treatment time and angle correction of idiopathic genu valgum.
それが私の患者ケアにどのように影響するか？
The trial was not able to show superiority of either hemiepiphysiodesis methods. Further studies with larger populations need to be conducted as this study may be underpowered.
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