FOOT & ANKLE
Surgical versus functional treatment for acute ruptures of the lateral ligament complex of the ankle in young men: A randomized controlled trial
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):77 J Bone Joint Surg Am. 2010 Oct 20;92(14):2367-74. Epub 2010 Sep 10.51 physically active Finnish men with the acute rupture of the lateral ligament of the ankle were randomized to be treated with either the surgical repair and accelerated functional treatment or with traditional functional treatment using Aircast ankle brace. The long-term results of surgical treatment of acute lateral ligament rupture of the ankle corresponded well with functional treatment modalities alone; however, the surgical treatment had a lower re-rupture incidence, but was associated with higher rates of osteoarthritis of the ankle joint.
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
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
1/4
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？
Lateral ligament ankle injuries are very common with over 300,000 cases reporting annually to emergency rooms in UK alone. The treatment of acute ruptures of the lateral ligaments is a controversial issue with insufficient evidence to compare surgical and non-surgical modalities. Previous studies have shown notable design flaws, such as short follow-ups, faulty randomizations, and heterogeneous study samples. This study evaluated the long term outcomes of the surgical vs non-surgical approaches.
主な研究課題は何ですか？
Does the surgery provide better long-term outcomes than a purely functional rehabilitation for the grade 3 lateral ankle ruptures?
重要な知見は？
- The prevalence of reinjury was 1/15 in the surgical group and 7/18 in the functional treatment group (risk difference: 32%; 95% confidence interval: 6% to 58%).
- The mean ankle score on Performance Test Protocol and Scoring Scale for the Evaluation of Ankle Injuries was not significantly different between the groups (mean difference: 8.3 points; 95% confidence interval:-0.03 to 16.6 points)
- Stress radiographs showed no differences between groups, with regard to the mean anterior drawer (1 mm in the surgical group and 0 mm in the functional group; mean difference: 0.7 mm; 95% confidence interval:1.4 to 2.7 mm) or mean tilt angle (0 degrees in both groups; mean difference: 0.1 degrees; 95% confidence interval: 3.2 degrees to 3.5 degrees)
- Grade-II osteoarthritis was observed on magnetic resonance images of 4/15 surgically treated patients and 0/18 for the functionally treated patients (risk difference: 27%; 95% confidence interval: 4% to 49%)
- 10/15 patients in the surgical group and 7/18 in functional group subjectively reported complete recovery (risk difference: 28%; 95% confidence interval: -5% to 61%). All patients in both groups recovered to preinjury activity level (walk and run normally)
- The level of physical activity, range of motion compared to contralateral ankle, and number of patients visiting a physician at the time of follow-up did not differ between the two groups.
- 3/15 surgical patients had loss of sensation in the lateral aspect of ankle and foot. No re-operations due to ankle instability, infections, or incidences of venous thrombosis were seen in either group.
最も覚えておくべきことは？
The recovery to preinjury levels of acute lateral grade III ligament rupture of the ankle was equivalent when using either surgical or nonoperative methods. Re-injury was significantly less in surgical group; however, there was significantly more OA present.
それが私の患者ケアにどのように影響するか？
This study questions whether to subject patients to surgical risks given the evidence of equal pre-injury recovery, and suggests that non-surgical treatments can be equally beneficial. However, larger sample sizes are needed to confirm these findings.
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