HAND & WRIST
Cast versus splint in children with minimally angulated fractures of the distal radius: a randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(18):28 CMAJ. 2010 Oct 5;182(14):1507-1296 children with a minimally angulated greenstick or transverse fracture of the wrist were randomized to receive either a wrist splint or a short arm cast for 4 weeks. The children were assessed for physical function at 6 weeks and degree of angulation at 4 weeks. Range of motion, grip strength, and complications were also noted. The two groups were not found to have significant differences for any of the outcome measures.
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
4/4
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？
Minimally angulated (15 degrees or less) distal radius fractures in children do not usually require reduction and are most commonly treated with a short arm cast for 4-6 weeks. Negative features of a cast include poor hygiene, risks from a poor fit, and discomfort. Splinting may be a viable alternative based on studies in adults, though a direct comparison with casting in children is needed before recommendations can be made.
主な研究課題は何ですか？
Is a prefabricated wrist splint as effective as routine casting in the recovery of physical function in children with a minimally angulated distal radius fracture at 6 weeks?
重要な知見は？
- At 6 weeks, the physical function score was a mean of 92.8 in the splint group compared to a mean of 91.4 in the cast group. The mean difference between the groups was 1.44 (95% CI -1.75-4.62). This was not a significant difference.
- At 1 week, the mean angulation of the splint group was 8.65 degrees compared to 7.92 degrees for the cast group. The mean difference was -2.43 (95% CI -2.43-3.90) and not significant. At 4 weeks the mean angulation had increased to a mean of 9.85 degrees in the splint group and 8.20 in the cast group for a mean difference of -1.65 (95% CI -1.82-5.11), which was not significant.
- The range of motion at 6 weeks was not significantly different between the groups.
- Grip strength at 6 weeks was not significantly different between groups, with a mean of 26.6 pounds in the splint group and 28.8 pounds in the cast group (mean difference of -2.16, 95% CI -7.34-3.02).
- The wrist pain score was not significantly different between groups at any time point.
- In terms of patient preference, 12% of the patients in the splint group would have preferred casting treatment. In contrast, 68% of patients in the cast group reported a preference for splinting. This difference in patient preference was significant (p<0.001). In addition, 5% of parents of children assigned to splinting expressed a preference for casting, whereas 60% of parents of children in the cast group would have preferred a splint (p<0.001).
最も覚えておくべきことは？
The use of a prefabricated splint was shown to have similar effectiveness to a cast in terms of patient function and fracture stability. In addition, the splint was associated with a higher level of patient and parental satisfaction.
それが私の患者ケアにどのように影響するか？
Due to what appear to be similar outcomes but different levels of patient convenience and satisfaction, the use of a splint may be a preferred alternative to casting in the treatment of minimally angulated distal radius fractures. The authors note that the sample size may have been too small to detect differences in all outcome measures.
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