HAND & WRIST
Early functional postoperative therapy of distal radius fracture with a dynamic orthosis: results of a prospective randomized cross-over comparative study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(9):10 PLoS One. 2015 Mar 30;10(3):e011772029 patients with displaced distal radius fracture were randomized in this cross-over trial comparing a vacuum-fitted orthosis and a plaster splint in postoperative rehabilitation. Following volar locking plate fixation, patients were randomized to one week orthosis wear followed by 3 weeks splint wear, or to one week splint wear followed by 3 weeks orthosis wear. Patient satisfaction and SF-36 scores were examined at 1 and 2 weeks after surgery, and range of motion and DASH scores were reported at 4 and 12 weeks after surgery. Aesthetics, handling, and hygiene were rated higher for the orthosis than the plaster splint, though no significant differences were noted in range of motion, SF-36 scores, or DASH scores.
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
1/4
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？
Distal radius fractures are a commonly sustained injury, with an increasing trend in patients undergoing surgery for treatment, particularly in displaced fractures. While extensive research focus has been placed on different methods of surgical management, by comparison very little research has gone into postoperative management and optimal rehabilitation strategies. More specifically, methods and duration of immobilization remain points of interest. Traditionally, plaster casts have been implemented, but there has been interest in whether removable, dynamic orthoses may also be effective while offering better comfort.
主な研究課題は何ですか？
How does patient satisfaction and functional outcomes compare between patients treated with a dynamic orthosis versus a plaster cast following volar locking plate fixation of a displaced distal radius fracture?
重要な知見は？
- After the first week, patients who received the orthosis rated aesthetics significantly higher than those who received the splint (p<0.001), though difference after the cross-over was nonsignificant (p=0.719). Handling and hygiene were rated significantly higher with the orthosis versus the splint among those who received orthosis in the first week (p<0.001), and those who received the orthosis in the second week (p=0.001).
- No significant differences were noted between groups in the rating of activity limitation, physical resilience, fitting, or postoperative pain items within the patient-satisfaction questionnaire (all p>0.05).
- Preference for the orthosis was expressed in 23/29 patients (p=0.017).
- No statistically significant differences between groups were observed in range of motion, SF-36, or DASH scores.
最も覚えておくべきことは？
Following surgical fixation of a displaced distal radius fracture, a vacuum-fitted orthosis was associated with greater patient satisfaction compared to a semicircumferential plaster splint with respect to aesthetics, handling, and hygiene, leading to greater patient preference. Patient-reported and function outcome did not significant differ in the short-term.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that fitted orthoses, such as the VacoHand dynamic orthosis, may be more appealing to patients, although the increased patient satisfaction does not appear to lead to, or be the result of, improved clinical outcome. The cost-effectiveness of fitted orthoses should be considered in subsequent trials.
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