SHOULDER & ELBOW
Design and application of Nickel-Titanium olecranon memory connector in treatment of olecranon fractures: a prospective randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):218 Int Orthop. 2013 Jun;37(6):1099-105. doi: 10.1007/s00264-013-1878-5. Epub 2013 Apr 1840 patients who suffered olecranon fractures were randomized to be treated with either the nickel-titanium olecranon memory connector (OMC) or by locking plate fixation. The purpose was to determine the efficacy of the OMC for functional recovery. After an average of 3.2 years of follow-up, functional recovery assessed through the Mayo Elbow Performance score indicated a significantly better outcome with OMC, whereas functional recovery measured using the Disabilities of the Arm, Shoulder and Hand (DASH) suggested no significant difference between groups.
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。
3/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
3/4
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？
Olecranon fractures represent a significant number of fractures occurring around the elbow. Internal fixation, tension-band wiring, plate fixation and intramedullary screws/nails have commonly been used to treat such fractures, although entail limitations. A nickel-titanium olecranon memory connector, made up of an intramedullary fixing lock, a base arc and two compression fixing arms, has been developed as a potential alternative treatment. Accordingly, a comparison to standard treatment methods was needed to determine its efficacy.
主な研究課題は何ですか？
What was the efficacy of the olecranon memory connector when compared to locking plate fixation for the treatment of olecranon fractures, assessed at an average of 3.2 years follow-up?
重要な知見は？
- Mean DASH score was 3.3 (+/-4.0) in the OMC group and 4.0 (+/-6.9) in the locking plate group. The difference was not significant (P=0.38).
- Mean MEP score was 86.7 (+/-12.5) in the OMC group and 79.8 (+/-12.3) in the locking plate group. The difference was found to be significant, indicating a superior outcome in the OMC group (P<0.05).
- MEP score for elbow function in the OMC group was excellent in 10 patients (50%), good in 7 (35%), and fair in 3 (15%). For the locking plate group, MEP score was excellent in 5 patients (25%), good in 10 (50%), fair in 4 (20%) and poor in 1 (5%).
- Poor MEP outcome for the locking plate group was due to a postoperative superficial infection. The was the only implant-related complication noted in either group. This also resulted in the patient being dissatisfied with their treatment
- Seventeen patients (85%) of both groups were very satisfied with their treatment. The remaining patients were satisfied with treatment (except for the case described above).
- Groups did not significantly differ with respect to range of motion in flexion, extension, pronation and supination.
最も覚えておくべきことは？
Functional recovery was significantly better with the olecranon memory connector when measured by the Mayo Elbow Performance score, but no significance was displayed between treatments for the DASH evaluation. Range of motion was not demonstrated to be significantly different between groups.
それが私の患者ケアにどのように影響するか？
These results preliminarily outline the possibility of alternative treatment of olecranon fractures with the olecranon memory connector, with a potential benefit in functional recovery. An investigation with a larger number of patients is required to confirm these results.
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