SHOULDER & ELBOW
A multicenter, prospective, randomized, controlled trial of open reduction-internal fixation versus total elbow arthroplasty for displaced intra-articular distal humeral fractures in elderly patients
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(5):67 J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):3-12. Epub 2008 Sep 2642 elderly patients with displaced intra-articular, distal humeral fractures were managed using open reduction and internal fixation (ORIF) or with total elbow arthroplasty (TEA). Assessment 2 years post-operatively supported the use of TEA in this elderly population. MEPS scores were significantly better in the TEA group, while DASH sores were superior during early follow-ups. These findings were accompanied by a trend towards a reduction in complications in the TEA 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
2/4
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？
Currently, the gold standard of treatment for displaced intra-articular, distal humeral fractures in young patients is open reduction and internal fixation (ORIF). The use of ORIF in the elderly is associated with less predictable outcomes, increasing the number of complications. Total elbow arthroplasty is an established treatment option for revision of internal fixation and may provide superior outcomes, if used as a primary treatment in this elderly population.
主な研究課題は何ですか？
Did open reduction and internal fixation or total elbow arthroplasty provide the best clinical and functional outcomes for elderly patients with displaced intra-articular, distal humeral fractures, when measured over a 2 year period?
重要な知見は？
- Intra-operative conversion between groups resulted in 16 patients receiving ORIF and 26 patients receiving TEA; 5 patient randomized to ORIF received TEA due to severe fracture comminution.
- The mean operative time was significantly shorter for the TEA group (108 +/- 21 minutes) in comparison to the ORIF group (140 +/- 38 minutes) (p=0.001).
- The mean duration of hospitalization was shorter for the TEA group (7.7 +/- 6.3 days), compared to the ORIF group (9.3 +/- 9.7 days), but this difference did not reach statistical significance (p=0.5).
- Patients who underwent TEA had significantly better MEPS scores at 3 , 6, 12, and 24 month follow-up (p=0.01, p=0.003, p=0.01, p=0.015, respectively).
- DASH scores at 6 week and 6 month follow-up assessments were significantly better in the TEA group (6 weeks: 43; 6 months: 31), compared to the ORIF group (6 weeks: 77; 6 months: 47) (6 weeks: p=0.02; 6 months: p=0.04)
- Re-operation rates were not significantly different between the ORIF group (27%, 4/15 patients) and TEA group (12%, 3/25 patients) (p=0.2)
最も覚えておくべきことは？
Total elbow arthroplasty resulted in significantly better MEPS at two years and provided superior DASH scores during early follow-up assessments, in comparison to those who received open reduction-internal fixation. These positive results were also accompanied by a trend towards fewer revision surgeries.
それが私の患者ケアにどのように影響するか？
Total elbow arthroplasty is a preferable treatment option for elderly patients with displaced intra-articular, distal humeral fractures, providing superior clinical and functional outcomes.
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