HAND & WRIST
Effectiveness of cast immobilization in comparison to the gold-standard self-removal orthotic intervention for closed mallet fingers: A randomized clinical trial
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(16):14 J Hand Ther. 2013 Jul-Sep;26(3):191-201. doi: 10.1016/j.jht.2013.01.004. Epub 2013 Feb 2760 patients with distal interphalangeal joint (DIPj) active extensor lag were randomized to determine the efficacy between cast immobilization treatment using either a Quickcast orthosis to be worn 24 hours a day or a removable, low temperature thermoplastic, lever-type orthosis. After 24-28 weeks, there were no significant differences between the two groups in regard to success rate, orthosis discomfort, satisfaction with orthotic design, DIPj flexion stiffness, incidence of complications, and grip and tip-to-tip pinch strengths. However, the Quickcast group experienced significantly greater active extension at the distal interphalangeal joint at 10-12 weeks and significantly less edema at 6-8 weeks compared to the low temperature thermoplastic, lever-type orthosis 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。
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
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？
Mallet finger occurs when the extensor terminal tendon in the long fingers is either lacerated or ruptured. Although this injury can be treated surgically, conservative methods where the distal interphalangeal joint (DIPj) is immobilized are usually preferred. However, it is unclear what type of immobilization device is the most appropriate in handling this injury. Therefore this study aimed to compare efficacy of treating closed mallet fingers using a cast worn 24 hours a day versus a removable, lever-type thermoplastic orthosis.
主な研究課題は何ですか？
Is cast immobilization of Type I mallet finger injuries more effective with Quickcast or a self-removable, thermoplastic, lever-type orthosis, measured over 24-28 weeks?
重要な知見は？
- At the 10-12 week evaluation, the QC group had a mean of 5° more active extension at the DIPj compared to the LTTP group (p=0.05). It was also determined that there was a correlation between edema and active extension, where the lower the edema, the more active extension at the DIPj (p=0.003).
- There was no significant difference in the orthosis success rate between the LTTP group (60%) and the QC group (81%) (Chi-squared: 3.31; Degrees of freedom: 1; p=0.08).
- ¬-At the 6-8 week assessment, significantly less edema was experienced in the QC group (0.4 +/- 0.9), compared to the LTTP group (1.1 +/- 0.8) (p=0.03). At all other time points there was no significant difference between groups.
- At the 3-4 week assessment there was no significant difference in median VAS pain scores between the LTTP group (0.2 cm) and the QC group (0.6 cm) (Wilcoxon Rank Sum (WRS) test: p=0.14). However, at the 6-8 week assessment median pain scores were significantly lower in the LTTP group (0 cm), compared to the QC group (0.4 cm) (WRS test: p=0.03).
- At the final 24-28 week evaluation there were no significant differences in mean VAS outcome satisfaction scores based on the orthotic design between the LTTP group (1.8 cm) and the QC group (1.0 cm) (p=0.23).
- There were no significant differences between the two groups in regard to active DIPj flexion stiffness, grip, and tip-to-tip pinch strength at any time point throughout the 28 weeks. At the final 24-28 week assessment nearly full recovery of both grip strength and pinch strength comparative to the uninjured finger were achieved for both the QC group (Grip strength: 96%; Pinch strength: 90.8%) and the LTTP group (Grip strength: 98.2%; Pinch strength: 93.4%).
- None of patients reported any cases of severe skin complications, such as ulcerations or necrosis.
最も覚えておくべきことは？
Following 24-28 weeks, the results of this study indicated that there were similarities between the Quickcast and custom-fabricated low temperature thermoplastic, lever-type orthosis groups regarding success rate, orthosis discomfort, satisfaction with orthotic design, distal interphalangeal joint flexion stiffness, incidence of complications, and grip and tip-to-tip pinch strengths. However, the Quickcast group experienced significantly greater active extension at the distal interphalangeal joint and less edema.
それが私の患者ケアにどのように影響するか？
Both the Quickcast and custom-fabricated low temperature thermoplastic, lever-type orthosis provide effective treatment of distal interphalangeal joint active extensor lag following injury. However, Quickcast may be a more suitable immobilization device as in this study less edema and more active extension at the distal interphalangeal joint were associated with this orthosis. In order to improve success rates further research is required to determine what the optimal immobilization period and orthosis discontinuation process are following a mallet finger injury.
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